Euro OTC News · 2013-06-25 · AESGP Euro OTC News No. 248 - 3 - 25 June 2013 The lack of...

Euro OTC News

The Association of the European Self-Medication Industry (AESGP)

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E-mail: [email protected] http://www.aesgp.eu

f 60BS e l f - c a r e : t h e f i r s t c h o i c e i n h e a l t h c a r e

No. 248 Special edition 25 June 2013

49TH AESGP ANNUAL MEETING LISBON ................................. 2

Main outcomes ............................................................................................................................... 2

The conference in detail: Setting the agenda for the self-care sector ............................................ 3 An insight into GSK’s strategic thinking ........................................................................................ 4 The OTC market in figures ............................................................................................................. 5 How to react to unexpected challenges ........................................................................................... 6

Industry leaders’ vision for the self-care sector’s future ................................................................. 8

Meeting citizens’ information and communication needs ........................................................... 11 New research on the public’s perception of self-care ................................................................... 11 The consumer’s expectations ........................................................................................................ 12 How best to communicate with consumers ................................................................................... 13 A 2.0 strategy to connect pharmacies and citizens ........................................................................ 14

Switch: A key driver of innovation in self-care .......................................................................... 14 Case studies of new self-care indications ...................................................................................... 15

Benign prostatic hyperplasia (BPH) in the United Kingdom ..........................................................15 Overactive bladder in the United States ..........................................................................................16

Regulatory considerations for reclassification – the Portuguese case ........................................... 18 The pharmacist’s perspective on switches .................................................................................... 19

Finding the right balance in the regulation of health claims for self-care products .................... 20

The perspective of the European Food Safety Authority (EFSA)................................................. 20 Where do we stand with health claims? ........................................................................................ 21 “Commission, you are not applying the law on health claims” .................................................... 22 Update on herbal medicines .......................................................................................................... 23

The role and potential of the medical devices sector in self-care ................................................ 24 The Parliamentary debate on the Commission’s proposed Regulation on medical devices ......... 24 Goal is safety and access ............................................................................................................... 25 The perspective of the notified bodies .......................................................................................... 25 The Commission’s comments on Parliament’s suggestions ......................................................... 26

A policy framework fostering innovation and empowering citizens to self-care ........................ 26 Good governance in the self-care sector - the view of the UK as co-chair ................................... 26 The view of the initiator – the European Commission .................................................................. 29

The view of a supporting Member State ....................................................................................... 30 Patient empowerment: European Commission launches two studies ........................................... 31

The European Medicines Agency’s view on patient empowerment ............................................. 32

Empowering citizens: Views from around the world .................................................................. 33 International Self-Care Day Promoting better lives for citizens across the world ........................ 33 Self-care school education programmes in Japan ......................................................................... 34

Self-care policy in Portugal ........................................................................................................... 34 Making concrete progress: The UK Self-Care Week .................................................................... 35 Farewell David Webber ................................................................................................................ 36 Invitation to London 2014 ............................................................................................................. 36

AESGP Euro OTC News No. 248 - 2 - 25 June 2013

49TH AESGP ANNU AL ME ETING L ISBON

MAIN OUTCOMES

The AESGP 49th Annual Meeting - the annual gathering of the self-care sector in Europe –

was held in Lisbon, Portugal, from 5-7 June 2013. Entitled ‘Realising the Self-Care Poten-

tial’, the conference looked at this overarching theme from three angles: marketplace, regu-

lation and policy covering non-prescription medicines – including herbal medicinal prod-

ucts - food supplements and self-care medical devices, the last area being relatively new for

AESGP. With more than 400 participants, including representatives from industry, Europe-

an and national governments and regulatory authorities, and the umbrella organisations of

pharmacists and consumers, the conference was once again very well attended.

The key outcomes of the conference can be summarised as follows.

Cooperation to realise the self-care potential

Participants agreed that in order for the potential of self-care to be fully realised, all stake-

holders need to work together, with each undertaking their responsibilities to ensure that the

value of self-care is well understood and communicated, and that products effectively reach

consumers, allowing them to practise responsible self-care.

An excellent basis for future collaboration is the report on “Promoting good governance for

non-prescription medicines”1. The report, published by the European Commission during

the AESGP conference, is the outcome of the work of a multi-stakeholder project group set

up in the context of the European Commission’s “Process on Corporate Responsibility in

the pharmaceutical sector”2 which included a Platform on “Access to medicines in Eu-

rope”3. Endorsed by the 27 EU Member States and 10 stakeholder organisations represent-

ing industry, health professionals, patients and consumers, the report acknowledges the val-

ue and contribution of self-care to citizens and healthcare systems and calls for continuing

action to promote the practice of responsible self-care. Stakeholders expressed their com-

mitment for action and the delivery of results in the coming months based on the project

group’s recommendations.

Support for innovation and commitment to evidence-based expansion of self-care

The challenges in getting market approval for innovative medicines and making them wide-

ly available to consumers were illustrated with case studies. Speakers identified unneces-

sary regulatory hurdles on the way to getting a product on to the market. Regulatory and

benefit-risk assessment procedures for medicinal products often focus on risks and fail to

take account of the benefits of non-prescription use and the need for a balanced evaluation.

References to the benefit-risk model developed by Brass et al. (2011) entitled “Improving

the decision making process for non-prescription drugs”4 served as a reminder that there is

scientific evidence indicating how to better regulate non-prescription medicines.

1 http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/otc_report_en.pdf

2 http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/process_on_corporate_responsibility/ index_en.htm

3 http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/process_on_corporate_responsibility/ plat-

form_access/index_en.htm#h2-5 4 http://www.nature.com/clpt/journal/v90/n6/abs/clpt2011231a.html

http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/otc_report_en.pdf

http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/process_on_corporate_responsibility/%20index_en.htm

http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/process_on_corporate_responsibility/%20platform_access/index_en.htm#h2-5

http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/process_on_corporate_responsibility/%20platform_access/index_en.htm#h2-5

http://www.nature.com/clpt/journal/v90/n6/abs/clpt2011231a.html


The lack of incentives to innovate in the self-care sector was also addressed, with case stud-

ies indicating that the current European regulatory framework falls behind other countries

with regard to basic reward measures (for reclassifications / new indications for non-

prescription medicines, EU countries offer only a one-year data protection period compared

to three years in the United States and Japan). Moreover, implementation of these data ex-

clusivity measures in the EU often proves inadequate.

Aimed at ensuring a better understanding of the practice of self-care, AESGP launched the

18th

Edition of the “Economic and Legal Framework study for non-prescription medicines”1

during the conference. This is a reference guide including market data and information on

the regulation of non-prescription medicines in 29 European and 16 non-European coun-

tries.

Advancing self-care to the benefit of citizens and health professionals

Sessions on self-care medical devices and food supplements addressed the challenges to and

opportunities for expanding the practice of self-care in these areas. Additionally, national

initiatives such as self-care education programmes in schools in Japan and multi-stakeholder

self-care platforms were presented, providing conference participants the occasion to dis-

cuss how to best communicate the value of self-care and engage citizens and health profes-

sionals in the promotion of self-care.

THE CONFERENCE IN DETAIL: SETTING THE AGENDA FOR THE SELF-CARE SECTOR

Pictured at the AESGP 49th Annual Meeting in Lisbon, Portugal, 5-7 June 2013 (from l):

Hans REGENAUER, AESGP President, Merz GmbH; Emma WALMSLEY, President, GlaxoSmithKline Con-sumer Health; and Andy TISMAN, Senior Principal, IMS Health

As AESGP President Hans REGENAUER indicated in his opening address, marketplace, regula-

tion and policy are the fields where the obstacles to the development of responsible self-care are

most prominent. They are the fields where appropriate measures to promote self-care need to be

designed and implemented. And even though they may not always be clearly separated, market-

place, regulation and policy are arguably the areas where the level of success in realising the self-

care potential can best be measured and assessed.

1 http://www.aesgp.eu/publications/studies/elf/

http://www.aesgp.eu/publications/studies/elf/


To achieve success, said Regenauer, we need to work together and create understanding among all

stakeholders. “Time and again we are faced with obstacles in the self-care sector that stem purely

out of a lack of understanding of self-care, its effectiveness, its potential, and even its limits. This

lack of understanding means that we often do not have the common ground needed to work with

others to achieve our common objective of empowered citizens getting rid of symptoms and becom-

ing healthy by using the right products and receiving the appropriate level of professional support.

In a sensitive area such as healthcare it is well accepted that concerns and precaution have their

place. But it is precisely because of the critical importance of healthcare for citizens and societies

in general that all stakeholders have an obligation to provide evidence to shed light on, to justify or

to dispel any concerns people may have. This is an absolute requirement to fight complacency,

meaning that current market, regulatory and policy conditions and limitations should constantly be

put into question. We should therefore take bold steps forward in order to innovate and improve.

Let us not forget that we all need to work together to realise the self-care potential.”

An insight into GSK’s strategic thinking

Emma WALMSLEY, the President of GlaxoSmithKline Consumer Health, said that the last three

years (i.e. since she joined GSK) had been very busy and exciting. “Our business is mainly fast-

moving consumer goods (FMCG) but the wellness business, including non-prescription medicines,

is at the best end of consumer goods. We therefore try bringing the best features together, taking

from FMCG the branding, the category management, the customer and retail and channel focus,

cost-consciousness, speed and agility and combining it with first-class core healthcare capabilities

such as guarantee of quality and compliance, serious science and the right partnership with

healthcare professionals. Taken together these are powerful capabilities for the broader self-care

sector.”

“So far we have been able to deliver on our core business’ growth and profitability. In a broader

perspective, for self-care I am extremely optimistic and ambitious. All citizens and all sectors are

increasingly talking about the healthcare agenda, be it retail, education or governments, the food

and cosmetics industry. Demographics are definitely on our side, with an ageing population requir-

ing 50% of healthcare expenditure, the growing urbanisation, the digital consumer. From the side

of market penetration there are huge growth opportunities, especially in Asia. We work in a chal-

lenging economic environment but it is up to our industry to free up the market for innovation and

communication.”

The Chair agreed that it is up to large companies such as GSK to make appropriate investment deci-

sions in line with the changing economic and demographic environment in all parts of the world.

He wondered if this would eventually translate into lower investments being made in Europe.

To this Walmsley replied with a heartfelt ‘no’. “There is no doubt about our long-term commitment

to the bigger healthcare agenda even if some short-term divestment decisions are taken to accelerate

profitability and create growth opportunities. This may be clear from the large investments made

over the past year in businesses around the world and in R&D. Portfolio management is just good

business, and 85% of our global business is now with 16 brand platforms. The divestment of our

drinks business is part of this rationalisation. We have been able to accelerate R&D into innovation

across our category platforms and have streamlined our supply chain. New investments have been

made in emerging markets such as India and Nigeria and these need the right kind of proximity in

local knowledge and management. But half of our consumer turnover is still in established markets

such as Europe and North America,” said Walmsley, “and the consumer business is very much at

the heart of our corporate strategy, also in these ‘old’ markets.”

Walmsley stressed the importance of harnessing the powerful pharmacy channel in Europe, of of-

fering true consumer value through innovation and of good communication with the consumer, also

in the new media. The industry is perfectly capable of controlling this communication through self-

regulation, she said. The growing of eHealth applications make it absolutely necessary for us in


Europe to get our act together if we do not want to be left behind in the electronic healthcare revolu-

tion.

The OTC market in figures

Andy TISMAN, Senior Prin-

cipal at IMS Health, provided

an insight into the performance

of the worldwide OTC market.

Although the OTC market

growth continues to outpace

the prescription sector (+4.6%

v +2.6%), growth is mainly

generated by emerging mar-

kets. This is driven by several

factors, including a high level

of out-of-pocket expenditure,

no legal Rx/OTC differentia-

tion, limited access to

healthcare and limited control

of Rx dispensing.

Worldwide, the traditional ma-

jor categories still dominate the

market, with Cough & Cold clearly

leading growth after a strong winter,

although the biggest growth

er - the category of traditional medi-

cines such TCM and Ayurveda – is

included in the category “All others”

(+11.6%).

In Europe, Cough & Cold products

enjoyed a strong 2012-2013 winter

season (+10.5%).

In Western Europe France and Ger-

many have returned to growth whereas

Italy - the recent growth

er - shows slowing performance

(see next page).

On the other hand, the emerging

regions Central & Eastern Europe

(CEE) and Middle-East/Africa

(MEA) have very different dynam-

ics from Western Europe.

In Central & Eastern Europe, Rus-

sia is continuing to drive most of

the region’s growth. In MEA,

South Africa’s fast growth is slow-

ing, Egypt and Algeria perform

strongly and other major markets are close to maintaining historic growth levels.


Latin American performance is driven by Brazil in terms of scale with Venezuela driving the

strongest growth. In the Asia-Pacific region, the different sub-regions show very different perfor-

mances. At country level, China drives scale growth for the region while India, Indonesia and Aus-

tralia are also important growth contributors. In this region the contribution of the “big 5” catego-

ries is smaller than in other regions due to the importance of TCMs. Many large Western compa-

nies are therefore investing into the R&D of this category of medicines, in response to wide con-

sumer demand for ‘natural’ products.

Asked what role traditional Chinese medicines might play in developing a strategy for emerging

markets such as China, India, Africa or Latin America, Emma Walmsley said she believed in global

brand platforms which can however be executed by local carrier brands. Overall, global brands are

being supported by local insight, and many traditional products are being imported into mature

markets such as Western Europe. “As long as we serve our consumers with innovation and the

products they need, we will be carrying out a winning strategy.”

How to react to unexpected challenges

Brian McNAMARA, the Division Head at Novartis Consumer Health, believes self-care will play

a much bigger role in future but to realise this we need to take action.

Sharing some of Novartis’ challenges in 2012 could provide learning for

the industry as a whole. Novartis had a very successful run from 2007-

2011, increased market share on key global brands, had profitability growth

and a strong reputation among consumers and healthcare professionals.

However, the company ‘stumbled’ at the end of 2011 through some quality

issues with the Lincoln, Nebraska plant supplying the Americas following

an FDA inspection. As quality issues could not be resolve while continu-

ing supplies, the plant was shut down voluntarily as providing the highest

quality products is of high priority for the company. Letting down loyal

consumers for nine months (for instance by being unable to supply Excedrin Migraine) was even

more difficult for us than dealing with the financial side, said McNamara. Getting quality right is

important for us but also for the industry as a whole. As a results of the shutdown we reviewed our


quality systems globally, made upgrades where needed, introduced new supply chain strategies and

invested heavily in plant equipment but also in people and processes. This experience should be a

lesson for industry as a whole.

We are on a journey. The Lincoln, Nebraska plant is now back up and running, although not at full

capacity. But we still have many things to do, and we will take them one step at a time, in order to

make sure that consumers everywhere in the world get products of the highest quality.

Despite the internal challenges at No-

vartis McNamara believed the industry

was facing a bright future. In order to

be successful we need to recognise

trends in healthcare in order to provide

people all over the world with products

that are easily accessible and affordable

to improve their day-to-day lives.

Three of these trends are: emerging

markets, an ageing population; and the

growing burden this put on the

healthcare systems.

On the first point, the OECD estimates

that the middle class in Asia alone will

grow by over 1.2 billion people by

2020, meaning that over 70% of growth in the self-care sector in the coming five years will come

from the emerging markets, which will need the right infrastructure to meet these demands.

As life expectance increases, the need for maintaining a healthy lifestyle increases, and our industry

can help by providing innovative therapies that will aid ageing consumers manage chronic illness

safely, easily and affordably.

According to the World Bank public expenditure on healthcare in the European Union could hit

14% of GDP by 2030 versus 8% just ten years ago. As governments are struggling to control costs

and spending, the weight is going to shift towards the individual. Self-care can therefore play an

important role in providing cost-effective solutions to decreased government spending while

providing consumers with more access to healthcare options.

In order to be successful, we need to align on the most important issues facing the industry (see

slide). Our success will depend on how good we are at shaping the issues, removing the barriers

and creating opportunities. We need to increase switches, continue to improve existing products

and reward innovation,

Consumer communication such as advertising, product labelling, brands, social and digital media is

fundamental to our industry, said McNamara, in order for the consumer to understand what our

products do, what the health benefits are and how to use them safely. There is a debate going on

around two critical areas, advertising and branding. Some stakeholders are concerned that umbrella

branding or advertising could lead to confusion, inappropriate use and overconsumption. I believe

on the other hand that these forms of communication are critical to conveying the right message on

the proper and safe use of our products, and that banning them would have a negative impact on

healthcare and lead to confusion.

To solve these issues we need to work together, said McNamara. One good example of stakeholder

collaboration leading to a win-win situation comes from Portugal, and the details will be revealed

during this conference. This good example should be taken forward in all countries and all regions.


Industry leaders’ vision for the self-care sector’s future

According to Vincent WARNERY, Vice President Consumer

Healthcare Europe and Global Development, Sanofi, regular consumer

research shows that consumers increasingly trust their self-medication

products. However, a recent study in France showed that there is a rela-

tively big gap in both consumer and general practitioner (GP) trust be-

tween self-medication and prescription-only medicines and also between

reimbursed and non-reimbursed medicines. This lack of trust in non-

reimbursed medicines is of course something that needs to be addressed

between the industry, the medical profession and the French government.

Some of the brands, which are

mainly local, said Warnery, are

‘sleeping beauties’ that can be

brought back to life through a

media campaign. This shows

great brand loyalty in the self-

medication sector, something

rarely seen in other sectors such

as cosmetics. This trust is sup-

ported by the pharmacy distribu-

tion channel, the absence of ma-

jor public health issues with self-

medication products and the re-

sponsible behaviour of the self-care industry.

But there is still room for improvement, said Warnery, as witnessed by the modest self-medication

market in France (7.6% v 10-12% in Europe) and the low consumer spending per inhabitant (€32.56

p.a. v almost €60 in Belgium). In France 69% of consumers ask their pharmacist for advice when

choosing a self-medication product and that only 11% are ready to buy these products on line.

Udit BATRA, President and Chief Executive Officer Consumer Healthcare at Merck KGaA,

looked into how the true value of self-care can be assessed and how this can

be communicated in a way that is well understood and accepted by all

stakeholders, including the general public, healthcare professionals and pol-

icy makers.

From a value perspective there is a financial and a non-financial compo-

nent. From a financial viewpoint, a U.S. study showed annual savings for

the healthcare sector of USD 100 billion from the use of non-prescription

products versus prescription products, 75% of which were indirect cost sav-

ings and 25% were from lower medicines costs. So there are financial ben-

efits for the system and for the consumer.

“Another benefit comes directly from the products themselves, and the most striking example for

me is smoking cessation,” said Batra. “In the first year after the introduction of the non-prescription

version of nicotine replacement therapy (NRT) the number of people wanting to quit smoking had

doubled.”

And this is only half the story which should be communicated, but it should not only be us, the self-

care industry, to do so. Behind us are the regulators and global organisations such as WHO. Once

the value and the long-term health benefits of self-care have been established in the minds of these

parties, the true value of self-care should be disseminated to consumers in a simplified and straight-

forward manner.


Asked by the Chair what to do when a growing number of products are getting de-reimbursed and

consumers are facing an ever higher out-of-pocket healthcare bill, Batra recognised this was a prob-

lem but that it would be rather short-term thinking if the self-care industry were to stop promoting

its products for that reason. In Europe; the funds saved to the healthcare system by self-medication

will primarily go to life-saving medication. And in other parts of the world self-medication is actu-

ally cost-effective, on top of having a long-term positive effect on public health.

David WRIGHT, Senior Vice President and Global Head at Boehringer Ingelheim Consumer

Health Care shed light on how consumers could be enabled to have access

to their self-care products. The places where consumers can have access to

non-prescription medicines are heavily regulated. When looking at the

marketplace 10-20 years ago it was fairly traditional and pharmacy orien-

tated, but then some markets became mixed with some or all non-

prescription medicines becoming available in multiple channels. Today

we see even more complexity and even more challenges for the industry in

the form of buying groups, integrated wholesale / retail organisations, na-

tional and international multiples; online sales, etc.

We should set ourselves a big task by choosing where to put our brands and how to calculate mar-

gins and profitability. Most of the investment will probably go to where the maximum return can

be expected from above the line and below the line communication. The dichotomy is that retail

compliance is not always as promised. Trust building with retailers is therefore important. Return

on the deployment of the sales force also needs to be maximised, and we have to reconsider some-

times carefully where to place our resources.

Pharmacists are best placed to capitalise on self-care by providing proper advice to their customers

but in many places, especially in Europe; they often fail to do so, and this needs to change. So be-

tween industry and retail distribution we need to work a lot harder by building education and trust

so that accessibility and visibility are enhanced. There is however no easy answer and success will

depend on our choices which we carry through.

Asked about the lack of success of the Flomax switch for Benign prostatic hyperplasia (BPH) in the

United Kingdom – a case study of which was to be presented the next day – Wright mentioned that

the company had learned a very difficult lesson: commercially, the switch was a disaster. The regu-

latory process developed a protocol which essentially bound together the patient, the pharmacist and

the doctor. For a man afflicted by a urinary problem this did not really feel like true access to self-

care which would allow him to go to the pharmacy and pick up the product. Another obstacle is

men themselves, who may feel that urinary problems are just part of ‘getting old’ and tend to wait

until the problem gets so bad that they will eventually go to see a doctor who may prescribe a medi-

cation which persons of a certain age may be given for free. Flomax was therefore a switch of

which industry as a whole cannot really be proud of.

The Chair remarked that this switch failure was in fact in conflict with the advice industry is given

to innovate and make more challenging products available for self-care.

Building a relationship with the pharmacist and the consumer, said Briain DE BUITLEIR, Chief

Executive Officer of PGT Healthcare (Procter & Gamble / Teva Joint Venture), is to be ‘a true

friend’. What does it feel like when somebody is a true friend to you? And what are you doing

when you are a true friend to somebody else? True friends know you better than most others, and

they get something from the friendship which is a two-way symbiotic relationship in which each

party is trusted.

1. We need to be a true friend to the consumer, especially to the developing middle classes in the

emerging markets. De Buitleir showed that virtually all over the world large international


companies are losing market share to local manufacturers, meaning “we are doing something

fundamentally wrong with the consumer, and there is a real opportunity to improve”.

2. We need to be a true friend to the recommender – a pharmacy assistant, your best friend in the

social media, your mother, etc. Even with the principal recommender - the pharmacist – we

need more scientific credentials, more support for services such as tests, and more advice for

commercial development.

3. We need to be a true friend to the regulator. I want more and better regulation, maintained De

Buitleir, because this drives out the poorly performing companies and

rewards the strongly performing companies which are prepared to in-

vest – the more the better.

To conclude, said De Buitleir, we know when we are being a true friend to

all three stakeholders, and we know when we are letting them down. I

believe there is too much complexity. I believe we can serve the consum-

er better without a single new ingredient. Instead, we should ask the

pharmacists more often how we can help them and we should ask the con-

sumers how we can better explain our products to them. We should

moreover demonstrate to the regulators that all the ingredients going into our products are of the

best quality and come from a trusted source.

Erica MANN, Worldwide President of the Bayer Consumer Care Division, agreed that it was

sometimes hard for consumers to make the right choices given the multi-

tude of products available, but said she still wanted to bring new products

to the market. Continuing on the importance of harmonisation of the

rules in which the industry operates, Mann highlighted the value of en-

gaging constructively with the people that regulate the self-care industry.

She quoted an example from the nutritional (food supplement) field to

illustrate this.

An increasing number of consumers look at their food to stay healthy and

at products that can help them do so. More than two-thirds of consumers

in Canada, Germany or Brazil are interested in preventative care, but regulations may vary. In Eu-

rope there have been

good efforts to harmonise

regulations, but when

looking at the 27 Mem-

ber States every one of

them may decide on

maximum and minimum

levels of nutrients.

The Member States also

decide how to regulate

herbal products, in spite

of some helpful global

and regional guidelines

from WHO on traditional

Chinese medicine (TCM)

and supplements and the

opportunity to reach

harmonisation through free-trade agreements.


“As a global leader I can confirm that just about every country in the world wants it done ‘their

way’, so you can imagine the complexity to provide consumers with the products they want to stay

healthy. It makes it hard from a regulatory but also from a manufacturing, distribution and cost per-

spective,” said Mann

“Satisfying the regulatory requirements concerning nutritionals of every country in the world really

puts an impediment on innovation.” But she remained convinced of the huge opportunity for indus-

try to step up its action and work together to generate better opportunities for consumers across the

globe. “We need to show the true value of self-care!”

MEETING CITIZENS’ INFORMATION AND COMMUNICATION NEEDS

Chair Urs HARTMANN, speaking on behalf of AESGP Vice-President Joerg OHLE, introduced

this session in which speakers looked at consumer expectations and perceptions of self-care.

New research on the public’s perception of self-care

Recent research by the Rheingold Institute on the public’s perceptions of

self-medication in Germany was presented by Anton van de PUTTE,

Member of the Board of Germany’s Bundesverband der Arzneimittel-

Hersteller (BAH). With the de-reimbursement of nearly all non-

prescription medicines in Germany in 2004, the turnover of non-

prescription medicines which were previously reimbursed (OTX) de-

creased considerably, both in value and in volume, and this trend is still

continuing. The BAH therefore wanted to find out what consumers feel

and expect with regard to self-medication and how communication can

be improved.

A morphological (in-depth-

psychological) study was car-

ried out through one-on-one

and group interviews among

58 participants (67% female,

33% male) aged 18-70 years

from four categories of con-

sumers (from occasional to

long-term medication users).

The study was designed to un-

cover sub-conscious percep-

tions, images and emotions.

Concerning the use of medi-

cines, German consumers are

ambivalent, said Van de Putte.

On the one hand they admire the progress achieved in medicine and pharmacology. On the other

hand they are sceptical about the use of medicines, and the reasons for this are threefold: Germans

have a certain innate anxious attitude (‘Angst’); they have a tendency to romanticise ‘nature’, and

they have a lot of perseverance and ‘will power’. The three taken together means that German con-

sumers will wait for a long time before “letting the genie out of the bottle” by taking a (chemical)

medicine as this is seen as an “external intrusion” and “meddling with nature”. This will in turn

lead to feelings of guilt, fear, bad conscience, risks and side-effects, which German consumers want

to avoid. This ambivalent attitude leads to an essential psychological problem which cannot be

solved, maintained Van de Putte.


Consumers perceive illness as the re-

sult of stress or overexploitation of

one’s own nature, but also as an ines-

capable destiny, as an external inva-

sion of “foreign powers” and as one

of the limitations of “everyday life”.

Consequently they will take medi-

cines, preferably ‘natural’ ones, only

when they are suffering, in particular

once their use has been “justified” by

a doctor or a pharmacist. They see

medicines as “prolonging life” but

like their medication to be dosed indi-

vidually. They also think that more

knowledge makes medicines more

predictable.

Consumers get information on medicines from peer recommendation, the Internet, TV and special-

ised magazines. Not surprisingly, doctors generally prefer prescribing Rx medication. The per-

ceived dissociation from traditional medicine leads to increased attention for ‘natural’ medicines.

Another feature appearing from the research is that consumers perceive a cloud of definitions (in

particular medicinal product, food supplements and medical devices) which they generally do not

understand. It is up to pharmaceutical manufacturers and pharmacists to strengthen the consumers’

own responsibility by providing orientation and safety and having them realise the intrinsic value of

these self-care products (pharmacy-only, medicine, self-medication…).

In conclusion, said Van de Putte, we need to build trust that:

Consumers can choose and use appropriately,

Companies intend to promote responsibly,

Pharmacist can be first-line healthcare professionals for less serious conditions, and

Regulators will take into account the value of access to and efficacy of non-prescription

medicines.

This trust will allow a self-regulatory post-publication control system for non-prescription advertis-

ing to work efficiently and responsibly.

The consumer’s expectations

The consumer’s expectations concerning self-care were presented by

Ilaria PASSARANI, Senior Health Policy Officer at the European Con-

sumer Organisation (BEUC), who thanked AESGP for the open dia-

logue of the past few years. Making better use of healthcare profession-

als in managing their own health is very much at the forefront of con-

sumers’ mind, especially

as consumer empower-

ment evolves with the

large number of mobile

applications becoming available (already more than

13,000). By the year 2030, said Passarani, the so-

called “bathroom doctor” will be taking a large

number of measurements recommending consumers

which medication to take. Moreover, the incentives

for consumers to maintain their health and lead a

healthy lifestyle are becoming stronger.


The guidelines for manufacturers concerning the information to be provided to consumers were en-

dorsed during the High-Level Pharmaceutical Forum in which both AESGP and BEUC participat-

ed, and the distinction information / advertising should be maintained.

According to figures from the European Medicines Agency, a large majority of package leaflets are

now being evaluated through user testing, leading to better package leaflets with less medical jar-

gon, better design and layout, larger print, more use of pictograms, more consistency between leaf-

lets for the same medicines in different

countries, and other improvements. For

non-prescription medicines the package

leaflet is even more important than for pre-

scription products, said Passarani. She was

therefore pleased that the European Com-

mission is conducting a study on the added

value of the PIL for the patient.

Among the information overload, it is often

difficult for consumers to choose, which

may in turn lead to paralysis. Her advice

was that consumer choice should be facili-

tated by making the information in the package leaflet / label as simple as possible so that consum-

ers trust it and can apply a simple checklist.

How best to communicate with consumers

Ana Margarida OLIVEIRA of the Portuguese Autoridade Nacional do Medicamento e Produtos

de Saúde (Infarmed) looked at consumer communication from the

point of view of a national competent authority. She confirmed what

the previous speaker had said about better access to information about

self-care and self-medication and greater consumer empowerment on

health. This had led to a change in attitude on control over health,

away from the paternalistic model towards a more participative model

and a patient / healthcare provider partnership. Good information on a

self-medication product and access to information for safe and correct

use will contribute to safe self-medication, said Oliveira. The role of

the national competent authority in this is to ensure that the information provided is accurate, rele-

vant, unbiased, easily accessible and up to date. This type of information is provided on the website

of the national competent authority, through labelling, package inserts, Public Assessment Report

and the assessment of advertising.

The changes in the EU’s pharmaceutical legislation introduced in 2005 had, according to Oliveira,

improved the quality of patient information (leaflets and labelling) and introduced publication of the

assessment reports. This was complemented in January 2009 by a revision of the Guideline on the

readability of the labelling and package leaflet. Subsequent transparency requirements had con-

cerned safety data (EudraVigilance), clinical trials (EudraCT) and medicinal products themselves

(EudraPharm).

Concerning advertising for non-prescription medicines, Oliveira highlighted the mandatory ele-

ments as well as the obligation to encourage the rational use of the medicinal product.

The national policy on the naming of medicinal products closely follows the EMA guideline in that

the name can be informative. Since 2012 Infarmed’s policy on umbrella trade names had become

more liberal, said Oliveira, in that the use of umbrella segments with a prefix or suffix was now al-

lowed for non-prescription medicines from the same marketing authorisation holder (MAH) con-

taining different actives in the same therapeutic area. In the case of INN + brand name, products


from the same MAH with different actives can maintain the same fantasy name. However, there is

no consensus on the European level on the use of umbrella trade names (yet).

Like Passarani before her, Oliveira also mentioned the current study on the readability of the patient

information leaflet (PIL) whose results are expected by the end of 2013. She hoped the study would

lead to improvements and further harmonisation in the approach to consumer information on non-

prescription medicines.

A 2.0 strategy to connect pharmacies and citizens

Albert PANTALEONI and Yolanda SANCHÍS of the Almirall Pharmacy Club demonstrated

what the Spanish company Almirall is doing to con-

nect pharmacies and citizens. After explaining how

the citizens’ purchasing decision had evolved from

and ordinary product via a solution product to an

‘emotion’ product, they speakers mentioned that in

the 2.0 Internet age citizens shared their experience

with a particular product via the social media. The

speakers showed the example of a product to treat

cellulites launched in the 1960s as a prescription medicine, which had

evolved to a consumer product for which the Pharmacy Club was created in 2003 and a dedicated

website on which consumers could ask questions in 2010. Consumer questions asked via the web-

site are answered through multidirectional (interactive) communication. The website also includes

a blog, a wall and personalised coaching, and allows consumers to create a patient record.

The website campaign was, so the speakers said, a big success in that the Pharmacy Club now has

10,000 active members, 5,000 e-learning participants and almost 4,000 Twitter followers. The

number of patient records rose to over 22,000 in 2012 without any product advertising in the ‘tradi-

tional’ media.

The eventual objective of the Pharmacy Club is to create brand loyalty and, through this, to attract

more visitors to the pharmacy.

SWITCH: A KEY DRIVER OF INNOVATION IN SELF-CARE

Roger SCARLETT-SMITH, Vice President of AESGP and President of GSK Consumer

Healthcare Europe chaired this session on innovative switches in the self-

care sector and said in his introduction that Rx-to-OTC switches offer po-

tential for growth, but that the process and execution are complex and suc-

cess in the market is not guaranteed. “Europe is an environment that is

complex, poses regulatory hurdles and offers slower industry growth.

However, the ageing population is asking for more years in good health

and more options to make own disease prevention choices. Moreover,

payers are increasingly keen to promote self-medication and OTCs and are

recognising the long-term cost-benefits of preventative treatments. One of

the key requirements for the success of self-care is driving interested consumers into well-prepared

pharmacies.

Among the benefits of switches, Scarlett-Smith mentioned that the non-prescription status of a med-

icine increases public awareness about conditions and treatment options, and thus reaches silent or

unaware sufferers. “OTC medicines are not simply symptomatic treatments for minor conditions,

but they have a direct role to support people undertake broader self-care behaviours and look after

themselves better. They are both convenient for patients and conserve the scarce healthcare re-

sources.”


Self-healthcare is therefore critical for a sustainable healthcare and corresponds to the growing push

in society towards preventative lifestyle and healthy nutrition. Communication technology is more-

over changing the way healthcare is delivered, said Scarlett-Smith. However, many challenges re-

main to be overcome in Europe. There is still no real single market for OTC products, and there are

major differences in switch authorisation procedures between the Member States. On account of

the limited functioning of the centralised switch procedure, there is in practice no working model

for switching in Europe from a business perspective.

Other factors hindering the switch process in Europe are the fact that data exclusivity is limited to

one year (v three years in the United States and Japan) and that the same regulatory framework is

applied to OTCs and prescription medicines, meaning that OTC-specific attributes such as like

quality of life enhancement and value of access and convenience are not taken into account. “We

are still facing reluctance of regulators to apply the WSMI tailored benefit-risk framework for med-

icines to be moved from prescription to non-prescription status,” concluded Scarlett-Smith. “Self-

care products are not low-class pharmaceutical products, but first-class personal care products.”

Case studies of new self-care indications

Benign prostatic hyperplasia (BPH) in the United Kingdom

Paul CARTER, Global Head Consumer Health Care, Development, Medicine and Regulatory Af-

fairs at Boehringer Ingelheim, presented the ‘Flomax Relief’ (tamsulosin

0.4mg capsules) Rx-to-OTC switch in the United Kingdom from a com-

pany perspective. He compared the switch to the

story of the Titanic’s maiden voyage: both journeys

were pretty similar apart from the fact that Flomax

had encountered not one but many icebergs on the

way to the market. Obtaining the marketing au-

thorisation had already taken four years of negotia-

tions with the regulators. And even after being au-

thorised end 2009 for the treatment of the functional symptoms of benign

prostatic hyperplasia (BPH) the product hit more icebergs.

The potential market for Flomax is men between 45-75 years of age with low-

er urinary tract problems. In the UK alone this represented a sufferer group of

between 1-3 million, but the actual users of the self-care product are “few and

far between”, said Carter.

Some of the reasons for this may be that the pharmacy is a hostile environment for men and that

sufferers would need to discuss their problems with a young - and probably female - pharmacy as-

sistant. They then need to fill out a questionnaire with 28 questions to ascertain that their disease

profile is correct to obtain the product. Answering the questions may take between 15 to 25

minutes. In many cases the customer gets referred to the doctor at this stage. If he nevertheless ful-

fils all the conditions, he gets a two-week supply (not the full four-week treatment), after which pe-

riod he will probably again get the recommendation to see a doctor or have to answer more ques-

tions.

The complete journey involved in obtaining a full 28-day treatment course of Flomax Relief is

mapped in the flow chart below, but “the chances of men actually purchasing the product after

overcoming the many hurdles on the way are really infinitesimal”, said Carter. He added that the

sales of herbal remedies and generic prescription products had on the other hand increased after the

Flomax Relief launch.

What is the moral of this “disaster voyage” story, asked Carter. Are men’s diseases the best choice

for a switch? And can prescription and non-prescription versions of the same medicine co-exist?


As a first reflection, Carter thought that complicated regulatory procedures and complex resulting

protocols are in not in the interest of pharmacists, medical doctors, regulators, industry or – most

importantly – patients. Second, “we need full OTC switches to enhance self-care”. Industry does

believe in innovative switches but our investment must have a chance to pay back.

“We cannot afford to repeat the Flomax Relief story too often, and many other recent switches have

also been unsuccessful. Helping patients nevertheless does require commercial success,” concluded

Carter.

Overactive bladder in the United States

Nancy MILLER-RICH of MSD Consumer Care presented the experience in obtaining regulatory

approval, in early 2013, for the marketing of Oxytrol Transdermal Patch

(oxybutynin 3.9 mg) for overactive bladder (OAB) in women.

When assessing

the switch oppor-

tunity, said Miller-

Rich, it was estab-

lished that OAB

was an unmet

need, and the Rx partner was already ap-

proached before the product was launched as

a prescription medicine.

From the overall company perspective a

switch would mean diversifying earnings

and increasing returns from the initial R&D

outlay. From the Consumer Division’s per-

spective, considerations were that 80-90% of

market growth had historically come from switched products, and that switches would continue to

drive step-change growth for the OTC industry.


The ‘untapped’ OAB sufferer population in the United States alone was estimated at approximately

33 million (men and women), with around 3.7 million sufferers currently being treated with a pre-

scription product.

The patch provides a unique point of difference with the oral form in that its efficacy is similar to

that of oral OAB therapies but side effects are lower due to the transdermal avoidance of first-pass

metabolism. Moreover, the patch provides four days of continuous therapy, versus the need to take

several (Rx) tablets per day.

According to Miller-Rich, OAB severely reduces quality of life and impacts on factors such as per-

sonal relationships, emotional wellbeing, sleep, energy levels and work and productivity. Self-

management of the condition is common, she said, with women focusing on coping with or con-

cealing their symptoms in several ways.

Ed HEMWALL of MSD Consumer Care continued by explaining the

company’s switch strategy. After defining the current OAB situation, the

Brass et al. benefit-risk model was applied to establish the benefits of

OTC access and demonstrate an acceptable incremental risk level. In co-

operation with the FDA, consumer behaviour studies were carried out on

label comprehension in order to develop a compelling data-driven ra-

tionale to engage and enrol external stakeholders such as urologists, wom-

en’s health groups, and pharmacists.

The data obtained showed that Oxytrol would

provide needed treatment and was a safe and ef-

fective pharmacological self-management tool.

Informative labelling was designed to increase

urinary health awareness and indicate when to

seek professional guidance. The data also

showed minimal additional risk compared to al-

ready on-going self-management. The ingredi-

ent’s efficacy had already been demonstrated in

two phase-3 studies carried out to support Rx

approval, and a large phase-4 study had shown

improvements on quality of life measures. The

actual use study (CONTROL) had moreover met

the primary endpoint in that 96.6% of users ex-

hibited correct behaviours.

All in all, said Hemwall, it took FDA 10 months to approve Oxytrol® for Women as the first-in-

class OTC treatment for overactive bladder in women aged >18 years. The incremental risks of

OTC were found to be acceptable to justify the benefits of greater access. The product was a new

therapy option for millions of women, it could be purchased without embarrassment and it would

help women take greater control over their condition. Comparing the U.S. switch environment to

that in the European Union, some features come to mind, according to the speakers:

The U.S. does not have pharmacy class, therefore it was necessary to prove consumers could use

the product without a professional gatekeeper

Investment in an expensive development programme was justified by the size of the U.S. market

and three years of market exclusivity

Advertising is allowed in the U.S. to create condition and brand awareness

There are no ‘local influences’ on implementation in the U.S. despite a wide range of cultural

and socioeconomic conditions.

It is as yet too early to judge Oxytrol’s commercial success, but the new switch has taken its place

in a long line of 20 switches started in the 1960s.


Regulatory considerations for reclassification – the Portuguese case

João CRISTÓVÃO MARTINS, Director of the Medicines Evaluation

Department at the Portuguese Autoridade Nacional do Medicamento e

Produtos de Saúde (Infarmed), informed the conference about plans to

introduce a pharmacy-only class of medicines in order to facilitate more

challenging switches. For the moment, medicines are classified into

prescription and non-prescription according to the EU criteria laid down

in Directive 2001/83/EC as amended. Non-prescription medicines are

distributed in pharmacies and specific OTC shops and dedicated areas in

supermarkets.

OTC status in Portugal is based on a list of Self-medication Indications developed by Infarmed and

stakeholders over the past decade (the so-called Self-medication consensus group).

Under a reclassification project car-

ried out in 2007-2008, an assessment

was initiated in case products with

the same active substance, strength,

pharmaceutical form and therapeutic

indications were classified as non-

prescription and prescription-only

with the purpose of granting the same

prescription status to all concerned

medicines. The result of this assess-

ment was that three categories of me-

dicinal products could be identified:

I. Medicinal products with all

indications included in the

self-medication indications list and therefore not needing any change or update

II. Medicinal products needing minor changes to the approved indication in order to comply

with the list and switch to non-prescription status

III. Medicinal products needing major changes and/or restrictions on the approved indication(s)

in order to comply with the list and switch to non-prescription status.

By 2007, the evaluation of group I had led to a total of 66 new non-prescription medicines. The

evaluation of group II was concluded in 2008 and led to the list being enlarged to 40 self-

medication indications (mainly in the therapeutic areas of pain, digestives, respiratory, skin and

general use products) and 37 new medicines being switched to non-prescription status. Reclassifi-

cation not being mandatory for products in group III, companies could decide whether or not to

change / remove indications to comply with the list.

Since then three new therapeutic areas have been considered as suitable for self-medication: chronic

urticaria, weight loss (orlistat) and reflux symptoms (pantoprazole), the last two because of the cen-

tral switch at EU level.

Wishing to take the reclassification project forward and feeling the need to see complex newly

switched medicines dispensed by a pharmacist, the Portuguese government has tabled a proposal to

create a pharmacy-only class of non-prescription medicines, the details of which were described by

Hélder Mota-Filipe (see page 30 of this report).


The pharmacist’s perspective on switches

The President of the Pharmaceutical Group of the European Union (PGEU), Maximin LIEBL,

mentioned the recently renewed Charter of Collaboration between

PGEU and AESGP1, which builds on earlier versions of the charter and

provides a unique opportunity for these stakeholders to work together.

Concerning pharmacy and self-medication, Liebl said that recent evi-

dence (e.g. Eickhoff et al, Pharmacoepidemiology and Drug Safety; Vol-

ume 1/3, March 2012) had shown that patients overwhelmingly prefer to

purchase non-prescription medicines from pharmacies, that there is clear

evidence that pharmacy counselling is expected and valued by patients

and that the potential for drug related problems in the non-prescription

medicines sector is significant. Moreover, pharmacists respond to patient symptoms presented in

the pharmacy and make recommendations based on reported symptoms. Evidence suggests that the

most common intervention is that pharmacists recommend patients to consult other health profes-

sions. He added that pharmacy practice does not vary significantly across the EU whereas pharma-

cy models do.

There is very significant evidence, said Liebl, that convenience is a major factor in encouraging the

use of pharmacies for non-traditional services. Pharmacist referral is a generally under-recognised

essential health service. “Our role in bringing patients into the healthcare system is vital”, he main-

tained.

In the area of switches, Liebl said that companies should consider whether they were creating an

inappropriate risk and whether they were responding to an unmet medical need. Any switch deci-

sion should therefore not be taken lightly.

Liebl further expressed concern about distribution models which would take switched medicines

outside the pharmacy. This would in his view present severe difficulties. In some cases, pharma-

cists would not feel comfortable without a prior medical diagnosis, and prostate problems and over-

active bladder may fall into this category.

Also, responding to acute and chronic symptoms may need different approaches. It is therefore

time to think about a new model of switches, said Liebl, as the present non-prescription / prescrip-

tion-only dichotomy is no longer fit for purpose. “For complex switches, our aim should ultimately

be to deliver the benefits of improved access while addressing concerns about the role of prescrib-

ers. This should be through a diagnosis / pharmacy intervention / physician follow-up model.

Although Liebl expressed understanding for any concerns on the part of medical doctors about mis-

diagnosis and masking of serious conditions, these concerns underestimate the fact that patients are

often reluctant to contact a physician.

“The lack of understanding between the medical and pharmacy sector is a major problem when it

comes to switches. However, the recent cooperation between the CPME, PGEU and AESGP in the

framework of the project on Good governance for non-prescription medicines (see the presentations

by June Raine and D’Acunto later in this report) had shown that there is a will for the three associa-

tions to take the cooperation forward, even though the pharmacists’ concerns over distribution can-

not be ignored”.

1 http://www.aesgp.eu/media/cms_page_media/68/PGEU-AESGP%2018-12_1.pdf

http://www.aesgp.eu/media/cms_page_media/68/PGEU-AESGP%2018-12_1.pdf


FINDING THE RIGHT BALANCE IN THE REGULATION OF HEALTH CLAIMS FOR SELF-CARE PRODUCTS

Chair Hubertus CRANZ, Director General at AESGP, gave an introductory overview on the histo-

ry of the 2006 Nutrition and Health Claims Regulation. The European Commission started this ini-

tiative with the objective of protecting consumers from misleading or inaccurate claims but also to

allow the food industry to use scientifically substantiated claims as a competitive marketing tool.

Pictured at the AESGP 49th Annual Meeting in Lisbon, Portugal, 5-7 June 2013:

Paulo MACEDO, Minister of Health, Portugal (centre), flanked on the right by Catherine GESLAIN-LANÉELLE, Executive Director, European Food Safety Authority (EFSA) and

Heitor COSTA, Executive Director, APIFARMA; and on the left by Valeriu CURTUI, Head Nutrition Unit, European Food Safety Authority (EFSA) and Hubertus CRANZ, Director General, AESGP

The perspective of the European Food Safety Authority (EFSA)

Catherine GESLAIN-LANÉELLE, the Executive Director of European Food Safety Authority

(EFSA) gave an overview of some of the recent activities to prepare the Authority for the challeng-

es of the coming years. She recalled that the European Agencies had undergone an external audit

last year. “Although the outcome was positive for EFSA a number of recommendations still remain

to be implemented. This will happen gradually.”

Transparency policy being revised

Geslain-Lanéelle enumerated as key values for EFSA: transparency, scientific excellence and inde-

pendence. In order to further improve the transparency of the Authority’s risk assessment processes,

the transparency policy is currently being revised, and a new policy on openness and transparency

will be developed in 2014. EFSA is also currently working of the revision of its communication

strategy aiming at increase of simplicity and transparency of its communications.


Investments in services to applicants

In the area of services to applicants EFSA has made a number of investments, including reorganisa-

tion of the Authority in 2011 and the creation of the Application Helpdesk Unit in order to intro-

duce a more customer-oriented approach in the area of regulated products. Geslain-Lanéelle

acknowledged that EFSA’s services to applicants are still not at the level of the European Medi-

cines Agency (EMA). She regretted that as a result of the European Commission’s February 2013

decision EFSA cannot introduce a fee system similar to that of the EMA and other European Agen-

cies. Although EFSA’s funding system continues to be based on public resources, Geslain-Lanéelle

mentioned that the Authority had introduced a number of initiatives aimed at improving the quality

of services for applicants. These include publication of guideline documents for applicants, tech-

nical workshops and trainings, and a recent survey on stakeholders needs.

Scientific work on claims, including botanicals

According to Geslain-Lanéelle, close cooperation with EFSA stakeholders – international organisa-

tions, Member States, consumers and industry – while maintaining the independence of EFSA’s

scientific advice is important. EFSA has already done a great deal of work in the area of scientific

assessment of claims by finalising its main body of work for health claims in June 2011.

“EFSA is now ready to assess the pending botanical claims within the current approach, which is

based on generally accepted scientific evidence. “This means that within the given framework

EFSA will not accept the tradition of use to scientifically substantiate health claims on botanicals,”

she said. “The current situation with botanical claims is indeed problematic, as many health claims

have already been assessed by EFSA on the basis of the approach laid down in the Nutrition and

Health Claims Regulation while botanical products on the market are still using claims without be-

ing scientifically substantiated.”

Importance of applicant interaction for AESGP

Cranz responded by pointing out the importance for AESGP of its membership in EFSA’s Stake-

holder Consultative Platform, which he called “an excellent forum for official interaction with the

Authority”. With regard to EFSA’s limited resources for applicant interaction, Cranz maintained

that an improvement in the interaction between EFSA and its applicants was one of the top issues

for AESGP. “AESGP has been advocating support for the idea of an EFSA fee system for years.

Given the negative outcome of the European Commission’s impact assessment on EFSA fees, an

alternative solution needs to be found in order to achieve a high level of services for EFSA appli-

cants.”

Where do we stand with health claims?

Basil MATHIOUDAKIS, the European Commission’s Head of Nutrition, food composition and

information, gave a comprehensive overview of the implementation status of

the Nutrition and Health Claims Regulation. In particular, he referred to a

new Commission Regulation1 which was about to amend the European list of

222 permitted health claims established by Commission Regulation (EU) No

432/2012 by adding six general function (Article 13(1)) health claims (dried

prunes and bowel function; alpha-cyclodextrine and postprandial glycaemic

response; Omega-3 related claims (3 claims); and fructose and blood glucose

rise.

Mathioudakis also mentioned that the additional 119 non-authorised claims for which the ‘reflection

process’ was concluded, had now been entered into the EU Register of Claims and should be re-

moved from the market by 2 January 2014. It is up to the Member States to control the correct im-

1 Subsequently published as Commission Regulation (EU) No 536/2013 of 11 June 2013 in OJ L 160 of 12 June 2013 - http://eur-

lex.europa.eu/JOHtml.do?uri=OJ:L:2013:160:SOM:EN:HTML

http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2013:160:SOM:EN:HTML

http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2013:160:SOM:EN:HTML


plementation of the rules on claims with the help of existing guidance documents, said Mathiou-

dakis.

‘Generic descriptors’

Mathioudakis further mentioned that the

European Commission had prepared a draft

Regulation (according to Article 1(4) of the

Nutrition and Health Claims Regulation)

setting the rules for the use of ‘generic de-

scriptors’ in applications. Generic de-

scriptors (denominations) are terms which

have traditionally been used to indicate the

particularity of a class of foods or beverages

which could imply an effect on health but may be exempted from the application of the Claims

Regulation following an application by the food business operator concerned. Examples of such

terms are: ‘digestive’ biscuits, ‘tonic’ water or ‘cough’ drops. Although these descriptors could im-

ply an effect on health, consumers do not perceive them as such. The draft Regulation was going to

be presented at the meeting of the Standing Committee on 12 June 2013 and is expected to be

adopted and published in the following months. The national competent authorities will be respon-

sible for deciding which terms are understood as ‘generic descriptors’ by the consumer in their

country.

Botanical and other claims ‘on hold’

Next steps would include further work on Article 13(5) and Article 14 claims under consideration

and on Article 13(1) claims currently ‘on hold’. The latter include 2,232 IDs (2,078 on botanicals

and 154 others, the latter including caffeine, carbohydrates1 and PARNUTS-related claims such as

very low calorie diets and foods with reduced lactose and improved lactose digestion), which are, as

Geslain-Lanéelle had remarked earlier, for the time being allowed to remain on the market.

With regard to botanical claims, said Mathioudakis, the European Commission had not yet taken a

decision on whether to retain the current EFSA approach or to change in favour of a ‘tradition of

use’ approach which would require amending the Nutrition and Health Claims Regulation.

“Commission, you are not applying the law on health claims”

Dagmar ROTH-BEHRENDT, Member of the European Parliament, emphasised that “there is a

European legislation on health claims in place which covers all food supplements and this legisla-

tion is not fully respected”. With this she criticised the European Commission’s decision to sus-

pend the evaluation of health claims for botanicals. According to Roth-Behrendt the European

Commission overstepped its powers. “One could even question if the law is not breached”. She

therefore called for an immediate continuation of the evaluation process, in which she was support-

ed by the European Consumer Organisation (BEUC) and many other interested parties. Roth-

Behrendt thought that even though additional legislative measures were being considered it was il-

legal to suspend the evaluation process in the interim period.

Help to applicants

Roth-Behrendt said that the services the European Medicines Agency (EMA) is providing to appli-

cants, i.e. scientific advice and support in the application process, are essential. She therefore ex-

pressed support for the idea of a similar system being installed by at EFSA. Roth-Behrendt said she

appreciated Geslain-Lanéelle’s statement that an adequate dialogue between EFSA and applicants

was important. She stressed however that this dialogue needs to be well structured, and pointed to

1 The claim on ‘carbohydrates and the maintenance of brain function’ was adopted by a qualified majority of Member States at the

Standing Committee meeting on 12 June 2013 and is subject to a three-month scrutiny period by the European Parliament and the

Council.


the EMA as a good example. Roth-Behrendt was also supportive of an EFSA fee system and hoped

that the introduction of such a system would be reconsidered. “In the meantime, an alternative solu-

tion could perhaps be introduced.”

Update on herbal medicines

Werner KNÖSS, the Chair of the Herbal Medicinal Products Committee

(HMPC) at the European Medicines Agency (EMA), provided the most

recent figures on

the uptake of the

‘traditional use’

registration proce-

dure for herbal

medicines and the

number of Com-

munity Monographs and List Entries ap-

proved. As of May 2013, said Knöss, 114

monographs, 10 list entries and 2 revisions

(now part of the HMPC’s regular work) had

been approved, representing an average of 20 new outcomes per year. As of March 2012, 75 deci-

sions had been adopted by consensus (>75%) whereas 26 had included divergent opinions.

Under the simplified registration scheme, more than 1,000 registrations had been granted, with over

1,000 applications currently under assessment. Knöss also showed figures on the main therapeutic

areas covered by these registrations.

Selected key elements from the HMPC’s Work Programme for 2012-2015 include:

Prioritisation and continuation of work on monographs and list entries

Regular revision of

monographs

Reporting on uptake and

impact analysis

Harmonisation of

assessment related to non-

European traditional herbal

substances

Communication (patients,

public, science)

Coordination with EU

bodies (e.g. EDQM, EFSA).

Claims on ‘botanicals’

Knöss mentioned that the HMPC had submitted comments to the European Commission on the lat-

ter’s September 2012 Discussion Paper, pointing out the particulars of traditional and other herbal

medicinal products. These products have a specific set of scientific data; their dosage and admin-

istration follow a therapeutic purpose; their quality requirements are clearly defined; they need ade-

quate labelling and post-market safety. In this they are different from other categories of products

such as foodstuffs, medical devices or cosmetics. Their legal framework has been harmonised at

EU level, guidance documents and Community monographs have been established, their long-term

access to the market is guaranteed and their classification should ensure transparency for patient and

public health, concluded Knöss.


THE ROLE AND POTENTIAL OF THE MEDICAL DEVICES SECTOR IN SELF-CARE

Pictured at the AESGP 49th Annual Meeting in Lisbon, Portugal, 5-7 June 2013 (from right):

Despina SPANOU, Director for Consumer Affairs, European Commission; Hans REGENAUER, AESGP President, Merz GmbH;

Dagmar ROTH-BEHRENDT, Member of the European Parliament and Rapporteur for the European Parliament on the proposed Regulation on medical devices;

Juozas GALDIKAS, Director, State Health Care Accreditation Agency (VASPVT), Lithuania; Gert BOS, President, European Association of Notified Bodies for Medical Devices (TEAM-NB); and

Hubertus CRANZ, AESGP Director General

The Parliamentary debate on the Commission’s proposed Regulation on medical devices

Session chair Dagmar ROTH-BEHRENDT, Member of the European Parliament and Rapporteur

for the European Parliament on the proposed Regulation on medical devices - which is for the mo-

ment being debated in the European Parliament’s lead Committee (ENVI) - enumerated in her in-

troductory remarks the points in the text put forward by the European Commission which could in

her view be improved. She notably made reference to one of her amendments (#140) that proposes

deleting a new provision (Rule #21) under Annex VII – Classification criteria. This new provision

states that “Devices that are composed of substances or combination of substances intended to be

ingested, inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the

human body are in class III” (the highest-risk class).

Roth-Behrendt further said she did not agree with the restriction of the Unique Device Identification

(UDI) system to high-risk medical devices as proposed by one of her fellow Parliamentarians.

With regard to the possibility of introducing a centralised procedure involving a new Scientific

Committee at European Medicines Agency’s which she is proposing in her report - Roth-Behrendt

said this idea was already raised in the European Parliament’s Resolution of 14 June 20121 that

called on the Commission to move to a system of pre-market authorisation for medical devices of

Classes IIb and III in the wake of the Poly Implants Prothèse (PIP) scandal. This resolution was at

the time supported by a large majority of Members of the European Parliament. She nevertheless

1 European Parliament resolution of 14 June 2012 on defective silicone gel breast implants made by French company PIP

http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-262#def_1_7

http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-262#def_1_7


seemed open to a compromise which would install a system that would be halfway between the Eu-

ropean Commission’s scrutiny mechanism and a pre-market authorisation procedure. This could be

done through strengthening the monitoring of notified bodies which would involve enlarging in-

house expertise and increasing transparency around these bodies’ subcontractors and subsidiaries.

Roth-Behrendt further floated the idea of creating centres of excellence for the review of conformity

assessment dossiers. This would involve limiting the number of notified bodies and allocating the

review of specific devices classes to certain bodies which should ensure high-quality work in their

speciality.

Goal is safety and access

The Director of the State Healthcare Accreditation Agency in Lithuania, Juozas GALDIKAS, ex-

plained what the main goals of the new Regulation on medical devices are, i.e. “having reliable

medical devices and promoting the accessibility of medical devices to the population”. He also

pointed out that the problems encountered by the users of medical devices - healthcare professionals

and consumers - included lack of information on medical devices.

As regards information to consumers, he noticed that advertising control should be enhanced as

well as citizens’ decision-making powers. He also made reference to the outcome of the project on

Good governance for non-prescription medicines carried out under the ‘Tajani initiative’ (see

presentations of Raine and D’Acunto later in this report).

Galdikas emphasised the competent authorities’

role in pre-controlling advertising for medical de-

vices and enhancing the supervision of notified

bodies.

He remarked that the cost of the implementation of

the proposed regulation on medical devices may be

a problem for some Member States and that this

should therefore not be forgotten when discussing

the proposal.

Galdikas concluded that the European Parliament

and the Council of the European Union – which

will from 1 July 2013 be presided by Lithuania –

have the power of turning this proposed regulation into the best model for the European Member

States, especially in light of experience gained at international level.

The perspective of the notified bodies

Gert BOS, the President of the European Association of Notified Bodies (Team-NB), said his asso-

ciation represented 29 out of the current 74 notified bodies involved in the conformity assessment

review of medical devices from Classes IIa, IIb and III as well as those Class I medical devices that

are sterile or have a measuring function. He shared the Team-NB experience with the Code of con-

duct adopted on 9 October 2012 that has been made mandatory for all of its members. The latest

additions concerned an extension to in vitro diagnostics; the possibility of unannounced visits;

product verification; a supervisory structure and peer assessment.

Bos regretted that notified bodies “are not all up to the same standard”. On the other hand, he ex-

pressed disagreement with any plans to introduce a medicinal product-like marketing authorisation

system for medical devices. On Rule #21 (see above), he highlighted inconsistencies in wording

with other rules of Annex VII of the proposed regulation. He also questioned the appropriateness of

classifying the products concerned by Rule #21 in the Class III category. Bos was of the opinion


that ingestible medical devices have their place within the medical devices legislation depending on

their primary intended mode of action.

Concerning the qualification of notified

bodies, Bos preferred clinical experts

such as surgeons to be available to noti-

fied bodies while remaining active in

their ever-evolving field of expertise.

He therefore opposed the establishment

of full-time contracts between notified

bodies and clinical experts.

Bos also noted that the clustering of

notified bodies had already been organ-

ised, with a relatively low number of

notified bodies being allowed to conduct conformity assessments for Class III medical devices.

The Commission’s comments on Parliament’s suggestions

The European Commission’s Director for Consumer Affairs, Despina SPANOU, welcomed the

European Parliament’s suggestion to reinforce the designation and monitoring of notified bodies.

The scrutiny mechanism was seen as a safety valve in order to ensure a high-level of public health

protection.

Concerning a possible pre-market authorisation system, Spanou referred to the Commission’s im-

pact assessment1 on the revision of the Medical Devices Directives which had concluded that such a

system “would not increase patient safety”. She noted that the impact assessment also provided in-

formation on the financial impact of the proposed regulation on small and medium enterprises.

Although she was not in favour of deleting Rule #21, Spanou acknowledged that it may have collat-

eral impact on several products. She therefore agreed that a classification change could be possible.

She justified the non-deletion of Rule #21 by the need to address devices that could be ingested or

inhaled. She further made reference to the development of a rapid alert system across countries.

Spanou mentioned that the European Commission is currently chairing the International Medical

Device Regulators Forum (IMDRF). Current issues discussed in this forum include a medical de-

vice single audit programme under which a standard set of requirements is being developed for or-

ganisations performing regulatory audits of medical device manufacturers’ quality management sys-

tems.

A POLICY FRAMEWORK FOSTERING INNOVATION AND EMPOWERING CITIZENS TO SELF-CARE

Chaired by AESGP President Hans REGENAUER (first part) and AESGP Director General Hu-

bertus CRANZ, speakers in this session looked at important European policy initiatives in the area

of self-care.

Good governance in the self-care sector - the view of the UK as co-chair

June RAINE, the Director of Vigilance and Risk Management of Medicines at the United King-

dom’s Medicines and Healthcare products Regulatory Agency (MHRA) presented the perhaps most

significant initiative in the area of self-care of the past 12 months, i.e. the Report of the working

1 Impact Assessment on the revision of the regulatory framework for medical devices http://ec.europa.eu/health/medical-

devices/files/revision_docs/revision_ia_part1_en.pdf

http://ec.europa.eu/health/medical-devices/files/revision_docs/revision_ia_part1_en.pdf

http://ec.europa.eu/health/medical-devices/files/revision_docs/revision_ia_part1_en.pdf


group on promoting good governance of non-prescription drugs in Europe1. The European

Commission’s process on Corporate responsibility in the field of pharmaceuticals2 launched in

2011 in the framework of the EU’s Renewed strategy 2011-14 for Corporate Social Responsibility3

(CSR) was brought a step closer to fruition with the endorsement of the outcomes of the Platform

on Access to medicines in Europe4 at the Steering Group meeting in Ireland on 17 April 2013.

Pictured at the AESGP 49th Annual Meeting in Lisbon, Portugal, 5-7 June 2013 (from l):

Sheila KELLY, Executive Director, Proprietary Association of Great Britain (PAGB); Salvatore D’ACUNTO, Head of Unit Food and Healthcare Industries and Biotechnology, DG Enterprise and Industry, European

Commission; June RAINE, Director of Vigilance and Risk Management of Medicines, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom; and Hélder MOTA-FILIPE, Vice President,

Autoridade Nacional do Medicamento e Produtos de Saúde (Infarmed), Portugal

Good governance, said Raine, is “the frame-

work of rules and practices by which the

stakeholders on a specific subject ensure the

accomplishment of the desired objective”.

The report had brought to light a number of

differences in national policies on non-

prescription medicines, including legal classi-

fication, distribution, reimbursement and pric-

ing and attitudes to the role of self-care. Yet

the classification criteria were clearly spelled

out in Directive 2001/83/EC as amended.

Raine highlighted the differences in uptake

and mentioned that the survey of active ingre-

dients had shown that 63 active ingredients

had been switched to non-prescription status in at least one of the 24 countries surveyed, and that 19

actives were available non-prescription in not fewer than 20 EU countries. However, only five ac-

1 http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/otc_report_en.pdf

2 http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/process_on_corporate_responsibility/index_en.htm

3 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52011DC0681:EN:NOT

4 http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/process_on_corporate_responsibility/platform_access/index_en.htm

http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/otc_report_en.pdf

http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/process_on_corporate_responsibility/index_en.htm

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52011DC0681:EN:NOT

http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/process_on_corporate_responsibility/platform_access/index_en.htm


tives (Acetylsalicylic acid; Ketoconazole (topical); Paracetamol; Orlistat and Pantoprazole) were

available for self-care in all EU Member States, the last two following a centralised switch.

Some of the report’s conclusions were that there was no correlation between the distribution and

reimbursement situation and the number of ingredients switched and/or market share or between the

size of the market and the number of substances switched.

The factors making for a successful switch, said Raine, included:

Safety, ease of use and appropriate monitoring for switched products

A clear beneficial impact on public health

Responding to the needs/demands of citizens and health professionals, in particular, in terms of

patient empowerment, timely access, access to improved treatments and improved quality of life

Fulfilling unmet needs and addressing conditions that would otherwise remain untreated

Embraced by health professionals.

The ‘10 commandments’

The 10 recommendations or, as Raine called them; ‘commandments’ emanating from the report

were:

1. Consider successful switch elements (see above).

2. Industry innovation - Where appropriate, marketing authorisation holders should think early in

a product’s lifecycle about what evidence would eventually be needed to inform a safe reclassi-

fication.

3. Early involvement of all stakeholders so that concerns can be addressed and training prepared.

4. An EU Network or Forum should be established for those within National Competent Authori-

ties who are directly involved in the licens-

ing and reclassification of medicines.

5. Stakeholders should work together to build

on the current list of molecules that are

available without prescription across the EU.

6. Stakeholder platforms should be established

at national level to share views and develop

strategies to reach a common approach to

supporting patient access to non-prescription

medicines

7. Stakeholders should develop ideas together

on the use of post authorisation studies,

questionnaires and algorithms within models

of supply of non-prescription medicines.

8. Self-care should be included within the education and training of all doctors and pharmacists.

Continuing professional development for health professionals is a key and is essential if the

necessary competencies are to be developed in the context of new reclassifications. Effective

communication and counselling should be an integral part of the pharmacy qualification.

9. Individuals should have access to health professional advice for appropriate self-care and self-

medication, in particular for newly reclassified products. Self-medication and self-care should

be recognised as an important skill and stakeholders are encouraged to facilitate development

of these skills from an early age.

10. Reliable information should be provided by manufacturers to healthcare professionals in a con-

sistent and complementary manner to help support patients who move between self-care and

the healthcare system, doctors and pharmacists should be informed when a medicine has been

reclassified.

Network of national experts on OTC medicines to be set up

Next steps would, according to Raine, include the establishment of an informal network of national

experts in Member States on OTC medicines; the Stakeholder Forum should collaborate on realis-


ing the potential of non-prescription access; and initiatives should be developed to take forward the

recommendations to enhance the knowledge and skills of citizens. “We should be seeing hard re-

sults from this in about one year,” concluded Raine.

The view of the initiator – the European Commission

Salvatore D’ACUNTO, the Head of the Unit Food and Healthcare Industries and Biotechnology at

the Directorate-General Enterprise and Industry - the European Commission’s service under whose

authority the process on Corporate responsibility in the field of pharmaceuticals is taking place,

complemented June Raine’s presentation by explaining the technical details of the process. This

non-legislative process was designed to foster the competitiveness of the European pharmaceutical

industry and was run in parallel to the update of the EU’s Transparency Directive 89/105/EEC de-

signed to facilitate the free movement of medicines without undermining the Member States’ com-

petence to organise the national or regional health systems, including the pricing and reimbursement

of medicines. Participation in the entire process was voluntary.

D’Acunto set out the methods and aims of the project on Good governance for non-prescription

medicines, enumerated the participating seven European trade associations and eight Member States

and explained the work programme and main findings. These contain both micro and macro health

considerations.

The project found that the main barriers to access for non-prescription drugs were:

lack of consideration for the public health benefit,

attitudes and knowledge of stakeholders,

differing views between stakeholders,

lack of awareness of the product,

lack of information for the patients and

reimbursement decisions.

The main elements contributing to a successful switch (already partially set out by June Raine)

were:

awareness of the availability of the product as OTC,

compliance with all safety concerns,

common approach by all stakeholders,

professional advice available to the patients,

involvement of pharmacists and doctors and

commercial interest from the manufacturer.

Next steps

As next steps, d’Acunto identified the completion of the legislative process on the revision of the

Transparency Directive (2013-14); finalisation of the process on Corporate responsibility in the

field of Pharmaceuticals (2013) with the adoption of the last reports and an encouragement of par-

ticipants under the Lithuanian and Greek Council Presidencies to take the outcomes of the various

groups forward; and identification of other issues to be addressed in the future new initiative on

strengthening the competitiveness of the pharmaceutical industry (2013-14). The last initiative was

announced the Commission’s Communication of October 2012, A Stronger European Industry for

Growth and Economic Recovery1. In this context, said d’Acunto, AESGP has provided good ideas

in the report which the Commission is digesting in order to leave a useful legacy for the next Com-

mission taking office at the end of 2014.

1 http://ec.europa.eu/enterprise/policies/industrial-competitiveness/industrial-policy/communication-2012/index_en.htm

http://ec.europa.eu/enterprise/policies/industrial-competitiveness/industrial-policy/communication-2012/index_en.htm


The view of a supporting Member State

Paulo MACEDO, the Portuguese Minister of Health, confirmed the Portuguese government’s

commitment towards finding new strategies in the face of the challenges posed by an ageing popu-

lation. “We must therefore shape new strategies. This also includes more support for self-care, re-

quiring the population’s more active involvement without necessarily engaging a healthcare profes-

sional.” In Macedo’s view, health policy should be patient-centred and not be paternalistic. We

should encourage citizens to choose what is right for them, said Macedo, and self-care fulfils citi-

zens’ expectations in this context. However, he warned that this cannot be divorced from the over-

all health needs and cannot be solely driven by consumerism. To fulfil the potential of self-care,

new and innovative products should be brought to the market, and he linked this to the tasks of the

self-care industry under the Corporate Social Responsibility (CSR).

Hélder MOTA-FILIPE, the Vice President of Portugal’s Autoridade Nacional do Medicamento e

Produtos de Saúde (Infarmed), reinforced the messages delivered by his Minister of Health and by

João CRISTÓVÃO MARTINS the previous day. The importance of non-prescription medicines

is clear, said Mota-Filipe, as they strengthen patients’ access to healthcare and have a positive im-

pact on the national health systems. However, as decisions on medicine classification are a national

competence and no harmonisation exists at EU level, the Member States and EU citizens would

both benefit from the knowledge-sharing between national competent authorities (NCAs) on the

national reclassification processes.

Mota-Filipe explained the Portuguese

government’s plans to take the re-

classification project started in 20021

forward. Feeling the need to see

complex newly switched medicines

dispensed by a qualified pharmacist,

the government has put forward a

proposal to create a pharmacy-only

class of non-prescription medicines

allowing products in group III to

switch to non-prescription status.

The conditions would be that the active ingredient is available without a prescription in at least one

of the following countries: Sweden, Denmark or the United Kingdom. The switch candidates list is

being analysed and defined

by a technical group consist-

ing of national experts with

recognised medical and

pharmacy qualifications.

The final pharmacy-only list

may contain up to 40 active

ingredients - of which 17

have already been evaluated,

and may eventually lead to

338 new switch authorisa-

tions.

Switch to non-prescription

status will thus be allowed

for pharmacy-only medicines if the INN and supply conditions are included in the Pharmacy-only

1 See page 18 of this report.


list and for other non-prescription medicines if the indications are included in the self-medication

indications list. Given that the pharmacy-only list is based on specific use conditions, specific sup-

ply protocols and pharmacist training are in development. The education, training and continuous

professional development in the area of self-care are moreover included in doctors’ and pharma-

cists’ regular study plans.

In summary, said Mota-Filipe, for switches to be successful it is essential that the national compe-

tent authority (NCA) and stakeholders ensure there is readable, timely and useful information for

citizens, that pharmacists are strongly involved and that there is patient education on self-care man-

agement.

Patient empowerment: European Commission launches two studies

“Empowering patients in the management of chronic diseases”…

Isabel DE LA MATA of the European Commission’s Directorate-General Health and Consumers

said she believed patient empowerment and self-care would have a growing

importance in the future. Discussions with the Member States under the

Danish Presidency had shown that patient empowerment, in particular

among patients with chronic diseases, was of interest to the Member States

but that there was no common understanding of what was concretely meant.

At the request of the Member States, the Commission has therefore

launched a call for tender on “Empowering patients in the management of

chronic diseases”, which is seeking to help understand the concept of pa-

tient empowerment and aims to identify advantages of and barriers to this

concept. The study will also look at how to best share and implement good patient empowerment

practices. Results are expected by the summer of 2014.

Self-management and self-care of a disease are part of patient empowerment by putting patients in

the driving seat and encouraging them to take charge of their own health, said De la Mata. This

should of course be done under supervision and in close collaboration with healthcare providers.

…and “Promoting self-care systems in the European Union”

A second study on the “Promotion of self-care systems in the European Union” will be launched

later this year. This study, which has been requested and will be financed by the European Parlia-

ment, will focus on the cost-benefit of self-care. It will be divided into two parts:

1. A cost-benefit analysis which should identify advantages and barriers of patient empowerment

uptake and the level of resources in health care systems which could be effectively managed by

self-care. It should also identify best practises used in the Member States.

2. The creation of a platform with experts in the field of self-care. The platform, which should

have clear objectives, deliverables and timelines, will, amongst other things, identify gaps be-

tween available data and the information which at present hinders the understanding of self-

care. It should also present a guideline on how to promote self-care and propose plans for a fu-

ture EU collaboration platform on self-care.

The outcome of both studies will feed into further and future work on patient empowerment. In this

sense they can be seen as the practical implementation of the recently published report on “Promot-

ing good governance” presented by June Raine.

Other initiatives fostering patient empowerment

De la Mata further discussed the Commission’s initiative on Active and Healthy Ageing, which

seeks to increase the healthy lifespan of citizens through the deployment of innovative solutions and

also has patient empowerment as a cross theme. eHealth is an equally strong driver to promoting

patient empowerment, she said.


The European Medicines Agency’s view on patient empowerment

How to further improve the benefit-risk methodology for non-prescription medicines

The Executive Director of the European Medicines Agency (EMA), Guido RASI, said that regula-

tors needed to refine their methods of assessing the benefit-risk balance of

a medicine and switch from “implicit” to “explicit” decision making, i.e.

to an approach involving explicit descriptions not only of all decision cri-

teria and interpretation of data but also of valuations such as the weighting

factors for potential treatment outcomes. “We need to find a method that

can be applied both to prescription and to non-prescription medicines.”

Ideally, regulators should also shift from using qualitative statements to

quantitative descriptions of the size of the net health benefits. He summed

up the advantages and disadvantages of the toolkits proposed by the Agen-

cy –qualitative methods involving an ‘effects table’ (the pilot phase ends in Q42013) and quantita-

tive methods based on multiple-criteria decision analysis (MCDA).

According to Rasi, the Brass et al methodology for non-prescription medicines (which was exten-

sively discussed at AESGP meetings in February 2012 and January 20131) had a value-tree to iden-

tify common domains for non-prescription medicines which was similar to the EMA’s ‘effects ta-

ble’. The Brass benefit-risk analysis proposed using a variety of tools, with a preference for the

MCDA method as advocated by the EMA. The Brass model is now incorporated in the December

2012 MHRA guideline How to change the legal classification of a medicine in the UK2, said Rasi.

How far should transparency in clinical trial data go?

Rasi also highlighted the (delicate) balance between transparency and support to innovation. Under

its ‘access to documents’ policy started in 2010 and the more recent provisions on clinical trials, the

EMA is to publish certain clinical data used to obtain a marketing authorisation through the central-

ised procedure. The increased transparency on the side of the EMA was decided in light of per-

ceived lack of consumer trust following several high-profile scandals (e.g. the Médiator case). Rasi

mentioned that this ‘publication policy’ with regard to clinical trial data is prospective and that ‘leg-

acy data’ continue to fall under the current ‘access to documents’ policy. The stakeholder consulta-

tion on the new policy was completed end April 2013, and the EMA is to present its draft policy for

public consultation by 30 June 2013, for the policy to come into effect in January 2014.

Activities to implement the EU’s pharmacovigilance legislation

The EMA’s activities concerning pharmacovigilance had increased considerably with the imple-

mentation of the new provisions adopted in 2010 and 2012. In 2012 these activities centred mainly

around public health and transparency and communication, said Rasi, whereas literature monitoring,

the introduction of the single PSUR assessment process and enhanced Eudravigilance functionali-

ties were temporarily put on the backburner due to lack of funding. He therefore welcomed the dis-

cussions on the possible introduction of pharmacovigilance fees.

The EMA is in the process of rebuilding 18 different databases, some of which will allow direct up-

loads on which pilots are ongoing to assess the error rates. The outcome of the quality control pilot

on the implementation of Article 57(2) was presented to industry associations on 22 May 2013, and

further meetings are planned to finalise the methodology.

Rasi concluded by expressing optimism for the future which may require the creation of new R&D

models. The many electronic applications would make it easier for patients to identify to which pa-

tient subgroup they belonged. “We need to start the journey early to be prepared for these new de-

velopments.”

1 See http://www.aesgp.eu/events/Copenhagen2012/report/ and http://www.aesgp.eu/events/Dublin2013/report/

2 http://www.mhra.gov.uk/home/groups/comms-ic/documents/publication/con213177.pdf

http://www.aesgp.eu/events/Copenhagen2012/report/

http://www.aesgp.eu/events/Dublin2013/report/

http://www.mhra.gov.uk/home/groups/comms-ic/documents/publication/con213177.pdf


EMPOWERING CITIZENS: VIEWS FROM AROUND THE WORLD

International Self-Care Day Promoting better lives for citizens across the world

Zhenyu GUO, the Chairman of the World Self-Medication Industry

(WSMI) and Chairman & CEO of Dihon Pharm, China, presented the phi-

losophy behind the organisation of International Self-Care Day on 24 July.

He showed that non-communicable disease (NCD) accounts for a growing

share of total deaths, especially in developing regions. Therefore NCD

prevention was of key importance, said Guo.

If responsible self-care is well practised, about 75% of the cases of heart

disease, stroke and type-2 diabetes, and 40% of cancers can be prevented

(WHO, 2008). The value of self-care is not only beneficial to the millions

of people with medical conditions, but also, and especially, to the billions who do not but could get

better health.

Guo showed that self-care is

really at the centre of a great

number of actions people

can take to stay healthy. He

expressed the hope that In-

ternational Self-Care Day

may soon be recognised by

the United Nations as an of-

ficial UN Commemorative

Day.

Guo went on to show what Chine, the China Nonprescription Medicines Association (CNMA) and

WSMI did for International Self-Care Day in 2012 and what the plans are for the 2013 event.

Guo mentioned that an Inter-

national Self-Care Foundation

(ISF) was established in Hong

Kong in 2012 dedicated to

promoting the health and

wellness of citizens through

tools such as ISD, but also

through other self-care educa-

tion projects.

In conclusion, said Guo, in

China we have found ISD to

be a very useful device for

raising consumer awareness

and engaging the authorities,

and we will continue to use it.

“But we do believe ISD must

have its usefulness in many

other countries, and we note in particular that the UK and Canada have developed similar events.”

News about and support materials for the organisation of a national Self-Care Day can be down-

loaded from a dedicated WSMI webpage1.

1 http://www.wsmi.org/intlselfcare_days.htm

http://www.wsmi.org/intlselfcare_days.htm


Self-care school education programmes in Japan

Self-care school education programmes in Japan are one of the key ac-

tions undertaken by the Japan Self-Medication Industry (JSMI) to influ-

ence public opinion an prepare people to take care of their health from a

young age, said Akira UEHARA, Chair & CEO of Taisho Pharmaceu-

tical Co, Japan.

Uehara showed that the Japanese OTC market had been shrinking since

2000 under the influence of regulatory chang-

es such as the abolition of retail price mainte-

nance and the deregulation of distribution

channels leading to aggressive price policies, the emergence of new com-

petitors in functional foods and the slow progress in Rx-to-OTC switch.

The Japanese government is moreover faced with an ageing population

(around 40% of over 65s by 2045) and the ensuing social security and

medical costs (now already around 20% of GDP).

Uehara, a founding member in 2011 of the Japan Federation of Self-

Medication Industry (JFSMI), explained that this federation - made up of

five independent organisations grouping 320 companies and covering

two-thirds of all sales in the OTC market - is preparing consumers from a

young age to take responsibility for their health and prevent lifestyle-

related diseases. To this end it is publishing and distributing each year

over 200,000 copies of the Self-Medication Handbook and providing sup-

port for school education on medicines.

Uehara’s company, Taisho, is also contributing to this education effort

with the Health Information Magazine “Self-Doctor” and the website

“Self-Doctor.net”. New curricula for junior and senior high school were

started in April 2012 and 2013, respectively. Key opinion leaders are be-

ing approached on how to utilise self-care in an ageing society, what the

cost of lifestyle-related diseases really is (USD 65 billion in 2010) and

how to prevent them. With all these actions, concluded Uehara, “Japan

can become a model where the promotion of self-care is beneficial to an

ageing society”.

Self-care policy in Portugal

Maria de BELÉM ROSEIRA, a Portuguese Member of Parliament

and a former Minister of Health, demonstrated with figures how the

self-care market had evolved in Portugal, how the national spending

and prices of self-care medicines had developed and how the per capita

spending on medicines compared to that in other European countries

expressed as a percentage of GDP.

She placed the practice of responsible self-care and the criteria and

methods which Drug Regulatory Authorities (DRAs) can use to deter-

mine a medicine’s suitability for self-care in the framework of the

World Health Organization’s Guidelines for the Regulatory Assessment of Medicinal Products for

Use in Self-Medication1.

1 http://apps.who.int/medicinedocs/en/d/Js2218e/, WHO, 2000

http://apps.who.int/medicinedocs/en/d/Js2218e/


Belem-Roseira also provided an insight into a project on medical ethics run in Israel, which in-

volved health literacy, patient education and self-management and in which 12 skills were found to

be common to most successful self-management initiatives: recognise and act on symptoms; use

medication correctly; manage emergencies; manage diet and. exercise; interact effectively with

health care providers; use community resources; adapt to work; manage relations with significant

others; and manage psychological responses to illness.

Making concrete progress: The UK Self-Care Week

Gill JENKINS explained that she was a general practitioner (GP) in a large city centre practice, a

member of the Bristol Commissioning Group and Board Member of the

Self-Care Forum and a supporter of the National Health Service (NHS) in

the United Kingdom. “We simply cannot continue to cope with the increas-

ing public demand for funds,” she said, “and we therefore need our popula-

tion to self-care better and apply preventative strategies from a young age.

Self-care is prioritised as a cross- cutting theme across all our work pro-

grammes.” As a patient Jenkins “wants the best outcome without complica-

tions from my long-term conditions.”

The Self Care Forum was set up in 2011 to further the reach of self-care

and embed it into everyday life. It is jointly funded by the Department of

Health and the Proprietary Association of Great Britain (PAGB).

With Self Care Week, this year taking place on 18-24 November, the

NHS is collaborating with the Department of Health and a large number

of stakeholders to spread the message. The detailed programme is still

being prepared.

In 2012, the theme was to “inspire NHS organisations, patient groups and

other health interested agencies to support and encourage patients and the

public to take greater care of their own & family’s health, by using the

2012 theme “Self Care for Life - growing older healthily” to target their

own audiences, to support them to practise self-care for life and improve

their health knowledge as they grow older.” Communication and materials are managed by the

Self-Care Forum, and resources are produced for specific patient groups.

These actions are sup-

ported by “choices”

websites of the NHS

and the Department of

Health, which filter

through to the local lev-

el. Another website

discusses “The Medi-

cine Cabinet Chal-

lenge”, and encourages

people to “Check out

what’s lurking in your

medicine cabinet and

refresh what should be

in there!”

Jenkins ended by show-

ing the “self-care con-

tinuum” which states that “Self-care must be an integral part of care and the healthcare system”.


Farewell David Webber

Outgoing WSMI Director-General David WEBBER, here seen with his farewell present, was

thanked for his 11 years of loyal services to the

worldwide self-care industry. Building and

strengthening associations in emerging markets

and setting up the self-care evidence base were

quoted by the AESGP President among Web-

ber’s main achievements.

In his reply, Webber thanked the audience and

the industry in general for its continued support

during his 11 years in office and recalled the

move of the World Federation to Geneva at the

beginning of his tenure.

This had certainly facilitated contacts with in-

ternational partners such as the World Health

Organization (WHO) or the World Intellectual

Property Organization (WIPO), said Webber.

Invitation to London 2014

At the end of the conference Sheila KELLY, the Executive Director of the Proprietary Association

of Great Britain (PAGB), said “this is my 28th

AESGP Annual Meeting since in 1985, and many

things have changed. When I started there were still many non-reviewed non-prescription products

on the market. Who would have believed then that all EU Member States would in 2013 agree on

the promotion of self-care? With a new European Parliament and a new European Commission tak-

ing office in 2014, it is now up to the industry to keep the momentum going. I am therefore inviting

all participants as well as all those interested in the latest developments on self-care around the

world to the 50th AESGP Annual Meeting, which will take place in London from 3-5 June 2014 in

conjunction with the 18th General Assembly of the World Self-Medication Industry (WSMI).”

Mark your Calendar!

50 years supporting self-care

50th AESGP Annual Meeting in conjunction with the 18th General Assembly of the World Self-Medication Industry

London | 3-5 June 2014

More information on http://www.aesgp.eu/events/London50/

http://aesgp.eu/50/

http://www.aesgp.eu/events/London50/

Euro OTC News · 2013-06-25 · AESGP Euro OTC News No. 248 - 3 - 25 June 2013 The lack of...

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