Conference Report
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Conference report
51st AESGP Annual Meeting
Barcelona, Spain | 26-28 May 2015
Citizen empowerment: A megatrend of the 21st century
Citizen empowerment:
A megatrend of the 21st century
was the central theme of the 51st
AESGP Annual Meeting which
took place in Barcelona from 26
to 28 May 2015. The meeting
gathered nearly 500 participants
from 42 countries, including
representatives of the European
and national governments and
regulatory authorities, media, the
umbrella organisations of health
professionals, consumers/patients,
as well as the consumer health
industry.
The event in Casa Llotja de Mar
was opened by Boi Ruiz, Minister
of Health of Catalonia, who wel-
comed the participants in the
capital of his region and empha-
sised the importance of self-care
for the health care systems and
citizen empowerment. This was
echoed by Agustin Rivero, Direc-
tor General of the Spanish Ministry
of Health, who highlighted the
efforts of the Spanish government
to promote self-care and make it
more available to the consumers.
"We need to empower citizens in
health care through new technolo-
gies, said Jordi Ramentol, Presi-
dent of the Spanish Association of
the Self-Medication Industry anefp
and CEO of Ferrer. He expressed
appreciation of the progress made
in Spain on the promotion of self-
care and stressed a need for conti-
nuous cooperation between the
authorities and the industry.
Opening remarks of Boi Ruiz, Agustin Rivero and Jordi Ramentol
The opening event at Casa Llotja de Mar
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Consumer Health Industry: how to provide the best service?
The messages of the opening evening were fol-
lowed up by Pedro Nueno, Professor in the De-
partment of Entrepreneurship at IESE Business
School and Professor and President at CEIBS
(Shanghai, Beijing). The increase in the life expec-
tancy of modern society is causing major and unaf-
fordable health costs, said Nueno. By that the im-
portance of the self-care sector is getting more and
more recognised and the cost savings are well do-
cumented.
Global perspectives on Citizen Empowerment
Roger Scarlett-Smith, AESGP President and Head of Global Categories at
GSK Consumer Healthcare, shared his enthusiasm about the direction that
self-care is taking and expressed hopes that a more positive business cli-
mate can be created which will lead the long-term improvements of consu-
mer empowerment. To make real progress for self-care and consumer em-
powerment, trust and collaboration between industry and policy makers are
needed, said Scarlett-Smith. The self-care sector needs a balanced policy
framework which would combine mandatory and voluntary measures that
expand consumer access, preserve information to consumers, protect priva-
cy and maintain consumer safety, at the same time allowing room for inno-
vation.
An overview of the OTC market trends, also in the context of consumer em-
powerment was presented by Andy Tisman, Senior Principal Consumer
Health at IMS Health. The global OTC market increased by 4,8% in 2014.
Particularly impressive was the increase in Latin America, but also South
Asia and the Middle East benefitted from the positive economic climate.
Less positive was the development in North America and Japan. Central and
Eastern Europe did again better than Western Europe.
Tisman noted that different industry sectors not only
pharma but also fast-moving consumer goods (FMCG)
companies are moving into consumer health and
wellness products. This shift of focus has led to new
transversal market segments of cosmeceuticals, nutra-
ceuticals and nutricosmetics, attracting new competi-
tors. The consumer empowerment is a major trend
and will be a key driver for growth in the future, con-
cluded Tisman.
Pedro Nueno
Roger Scarlett-Smith
Andy Tisman
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We have a highly regulated European framework
which protects us and it will not be appropriate to
leave it away, urged Dagmar Roth-Behrendt, a
former Member of the European Parliament, com-
menting on the new Better Regulation initiative of the
new European Commission. Roth-Behrendt said that
better regulation efforts are supported if they aim for
a good overall balance. Not every lifting of rules is
leading to better regulation. She called for a cautious
approach when it comes to ideas to change of legisla-
tion as the outcome in the current political constella-
tion is very uncertain. In addition, the legislation in
place is often not so bad but the problem is with its
implementation.
Marketing authorisation and variation procedure for
medicines with well-established substances are cer-
tainly too complex. Communication rules are often no
longer in line with information society and the intel-
lectual property rights are insufficient for the work
done in the area of innovation with well-known subs-
tances. Innovation needs to be made easier through
well-functioning centralised and national procedures,
including the move of medicines from prescription to
non-prescription status.
New technologynew guidancebetter self-care
Today, new technology is key to drive the consumer empowerment, pointed out Brian McNamara, Region
Head Europe and Americas at GSK Consumer Healthcare. This creates unprecedented opportunities for the
consumer health care industry. The companies with innovation potential will have the most to gain.
We therefore need to continue investing in innovation, called McNamara on the conference delegates.
Current trends in digital health were presented by Ryan
Olohan, Industry Director Healthcare at Google. He gave
numerous examples of self-care electronic devices and
smartphone applications used for monitoring and sup-
port for diagnosis as well as online networks, social chan-
nels and health related videos for consumers and pa-
tients. Olohan also revealed that 1 in 20 Google queries -
equivalent to 3.5 billion searches everyday - is health care
related which indicates a growing patient and consumer
empowerment.
Dagmar Roth-Behrendt
Brian McNamara
Ryan Olohan
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Among the top search categories are headache,
indigestion, skincare and allergies. Google also
recognises that a major global trend is internet
access from mobile devices, including new inter-
net users.
A large number of digital health startups are emerging into the healthcare sector while classic pharma and
med tech players respond slowly to this trend, said Ashley van Heteren, Associate Partner at McKin-
sey&Company. Companies must address many questions related to digital healthcare in order to really benefit
from technological innovations and to make them useful for consumer empowerment.
By 2020, 75% of all deaths and healthcare costs will result from chronic
diseases estimated Didier Deltort, Global Monitoring Solutions Gene-
ral Manager at General Electrics Healthcare Finland, who looked at glo-
bal trends in health. An increased number of chronic diseases will in-
fluence the future of industry and is expected to drive structural
changes of healthcare, said Deltort. General Electrics Healthcare pre-
dicts that a shift from todays healthcare delivered in analog/paper way
to tomorrows digital/networked tools will enable real-time, continuous
information flow and comprehensive view of health and chronic disease
management, wellness and prevention.
Carlos Lens of the Ministry of Health in Spain,
highlighted recent measures of the Spanish go-
vernment, taken in collaboration with the Spa-
nish Association of the Self-Medication Industry
(anefp), to promote the self-care sector to en-
sure that citizens can practise self-care more res-
ponsibly. This included enhancement of prescrip-
tion of non-reimbursed medicines by medical
professionals.
Ashley van Heteren
Didier Deltort
Carlos Lens
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How to make health care affordable?
With the ageing populations, increasing disease
burden, and new treatment options, the global
healthcare costs become unaffordable. The role of
self-care in the sustainability of the healthcare sys-
tems becomes increasingly recognised by the natio-
nal authorities, highlighted Jaume Pey, Director
General of the Spanish Association of Self-
Medication Industry (anefp). He emphasised that
investing in self-care provides significant savings for
the national healthcare systems.
The economic impact of a hypothetical switch of a
medicine from prescription (Rx) to non-prescription
status (OTC) in Spain was analysed by Laura Pellis,
Senior Researcher Center for Research in Health and
Economics (CRES) at the University Pompeu Fabra
(UPF) in Barcelona. According to the CRES study, a
switch of 5% of prescription medicines used to treat
minor ailments to non-prescription status would ge-
nerate total savings of over 3 million EUR for Spain
over 5 years.
These results show the positive impact of
self-care for the entire health care system
thanks to its contribution to increased
patients empowerment noted Pellis.
She concluded that the positive impact of
Rx-to-OTC switch from a societal point of
view should be combined with in-
vestments in educational programmes on
patients self-care.
Health care professionals, including medical
doctors, play an important role in supporting
and promoting self-care. Integration of self-care
medicinal products in the Electronic Prescription
System REC@T in Catalonia was explained by
Toni Gilabert, Director of Pharmacy and Medi-
cines at Catalonia Health Department.
Jaume Pey
Laura Pellis
Toni Gilabert
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The advantages of the system are improved patients
safety in the context of avoiding medicines interac-
tions, increased patients empowerment, promotion of
sustainability and rational use of medicines and facili-
tation of coordination and communication among the
health care professionals.
Greece has one of the lowest percentage of pharmaceutical ingredients classified as OTC in the EU, said
Harris Mylonas of the National School of Public Health in Greece. He presented results of a case study on
the economic value of switching medicines from prescription to non-prescription status in Greece, which
showed significant benefits from a possible OTC list expansion, with overall savings for the national economy
summing up to 160 million EUR.
The new EU Platform for the
promotion of self-care
systems
PiSCE - the EU-funded pilot project on the promo-
tion of self-care systems in the EU - was presented
by Rosa Suol, Director General in Avedis Dona-
bedian Institute in Barcelona. The Avedis Institute
is one of the international organisations involved
in the PiSCE Consortium, along with the Dutch
Institute for Healthcare Improvement, the Danish
Committee for Health Education and the Standing
Committee of European Doctors (CPME). Suol
explained that the PiSCE project work on guide-
lines on the promotion of self-care and on actions
fostering collaboration on self-care at the EU level.
This included the creation of the PiSCE Platform of
25 European experts in different areas, including
policy makers, consumers and patients, healthcare
professionals, educators and researchers.
Harris Mylonas
Rosa Suol
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The doctors perspective on the promotion of self-care in the EU was given by Birgit Beger, Secretary Ge-
neral of the Standing Committee of European Doctors (CPME). Beger highlighted that in order to identify
the areas where self-care can and should be promoted, necessary evidence needs to be collected, to pro-
vide a common understanding of which minor or acute ailments or long-term conditions are manageable
through self-care.
Low health literacy is a barrier to self-care, highlighted Cristina Cabrita, Senior Project Officer at the Portu-
guese Consumer Organisation (DECO) speaking on behalf of the European Consumer Organisation (BEUC).
The results of the consumer organisations survey on self-management of chronic diseases carried out in
Belgium, Italy, Spain and Portugal show that around half of the consumers surveyed in these countries are
lacking skills when trying to find health-related information on the internet. One third expressed difficulties in
using simple information on drug administration and 40% of the consumers surveyed in Spain to nearly 70%
in Portugal do not feel at ease to ask health professionals to explain unclear issues about their health pro-
blems. Cabrita noted that these are the barriers to effective self-care which should be addressed by the PiSCE
project in order to create a more self-care friendly environment.
The new communication technologies have poten-
tial to provide citizens with truthful, relevant and
high quality information to enhance their self-care,
recognised Carmen Pea, President of the Interna-
tional Pharmacists Federation (FIP). Pea called on
doctors, pharmacists, patients and industry to
further cooperate and agree on how to enable the
European citizens access to responsible self-care.
Birgit Beger
Cristina Cabrita
Carmen Pea
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The pharmaceutical industry works intensively to
provide relevant and accurate information to the citi-
zens, summarised Jaume Pey, Director General of
the Spanish Association of the Self-Medication In-
dustry (anefp). Pey illustrated this with the Spanish
self-regulatory assessment for advertising of non-
prescription medicines which was developed by
anefp. Pey also said he was supportive of training
programmes for the pharmacists.
Jaume Pey, Rosa Suol, Birgit Beger, Cristina Cabrita and Carmen Pea
Self-care medical devices and food supplements:
New drivers for the self-care market?
The new comprehensive AESGP Databanks
system on regulatory, legislative and market
provisions on self-care products was official-
ly launched at the conference by Hubertus
Cranz, AESGP Director General. The new
Databanks system includes the on-line
AESGP Med Databank on medicines with a
new dedicated section on medical devices
and the new on-line AESGP Databank on
food supplements.
The comprehensive AESGP Databanks system should be a
most useful tool for companies to set market transparency
and is in line with the AESGP commitment to provide evi-
dence as part of its political activities. Evolution of diffe-
rent regulatory environments of product categories in-
fluence and drive the self-care market, the conference
delegates heard. Medical devices and food supplements
are gaining an increasing role in self-care and by that they
are getting a lot of attention both from the business as
well as from the regulatory communities.
The role of the European Food Safety Authority (EFSA)
for the food supplements industry was explained by
Valeriu Curtui, Head of the Nutrition Unit at EFSA, who
focused on the scientific evaluation process for health
claims and stressed that EFSA applies the highest stan-
dard of scientific evidence for all claims.
Hubertus Cranz
Valeriu Curtui
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Dr Curtui also explained that EFSA is in charge of the
safety evaluation of food supplements ingredients as
well as processing aids such as food additives. He also
revealed that the EFSA Compendium of botanicals of
concern when used in food or food supplements will be
updated by the end of 2016.
Insights on the current revision of the medi-
cal devices legislation were shared by Gwe-
nole Cozigou, Director of Internal Market,
Industry, Entrepreneurship and SMEs Direc-
torate GROWTH at the European Commis-
sion. Cozigou said that the Commission
proposal for a new regulation on which the
European Parliament expressed a first rea-
ding position in 2014 is now being intensi-
vely discussed among the Member States
experts in the Council. One of the key issues
is the Rule 21 for substance based medical
devices. The Latvian Presidency of the
Council is trying to enable agreement on a
compromise text by the end of its mandate in June 2015. The rapid adoption of the new regulations on me-
dical devices is important to restore confidence in the EU regulatory system and to ensure competitiveness in
this industry sector concluded Cozigou.
In the given context, the audience appreciated an up-
date on the European regulatory framework for herbal
medicinal products and the options for market access
were explained by Werner Knoess, Chair of the Com-
mittee on Herbal Medicinal Products (HMPC) at the Eu-
ropean Medicines Agency (EMA). Knoess presented the
set of requirements for herbal medicinal products inclu-
ding quality, safety, efficacy, labelling, advertising and
pharmacovigilance. He also expressed his wish to have
clear definitions of the different legal categories of pro-
ducts, which would allow better categorisation/
distinction of medicinal products, food supplements,
medical devices and cosmetics.
Werner Knoess
Gwenole Cozigou
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Switching: A mega trend?
Switching is not just a mega trend, it is a necessity for our industry, stated Suneet Varma, President of
Pfizer Consumer Healthcare. He addressed the benefits of a potential switch of statins in the U.S. in the
context of efficiencies, outcomes and savings.
Faster access in case of emergency, con-
venience for patients and savings of
healthcare resources were key reasons for
switching ellaOne to OTC, said Frd-
rique Welgryn of HRA Pharma who ana-
lysed the recent switch of an emergency
contraception pill ellaOne (ulipristal
acetate) through the EU wide centralised
procedure. HRA Pharma estimates that
thanks to switch of ellaOne from pres-
cription to non-prescription status over 48
million more European women will be able
to get the morning-after pill. Such a broad
impact was possible thanks to the suc-
cessful use of the EU centralised
procedure.
Legislators need to ensure that self-care is at the
heart of the healthcare system, said Darragh
OLoughlin, President of the Pharmaceutical Group of
the European Union (PGEU). The regulatory environ-
ment must be balanced, proportionate and focused
on meeting the needs and expectations of patients
and other stakeholders. According to the studies pre-
sented by PGEU, patients in many countries prefer to
access self-medication in pharmacies, even when avai-
lable from other sources. Switching naturally expands
the role of pharmacists said OLoughlin.
Suneet Varma
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We urge the national medicines agencies to be
sensitive to the changing society of increasingly
empowered citizens said Beln Escribano, on be-
half of the Spanish Agency for Medicinal Products
and Medical Devices (AEMPS). She explained the
way AEMPS enables access to information on me-
dicinal products including a dedicated mobile ap-
plication, a regional e-prescription system listing
both OTC and Rx medicines and guidance on um-
brella branding.
Frdrique Welgryn, Beln Escribano, Darragh OLoughlin, Suneet Varma and Hubertus Cranz
How to ensure availability of safe products?
Protection of human health and product safety
are number one priority for the industry stressed
Vincent Warnery, Senior Vice President of Sanofi
Consumer Healthcare Division. He noted that the
safety of medicinal products needs to be put in
the context of a benefit-risk balance. He
highlighted that this is a part of the responsible
approach of the consumer health industry and
needs to be addressed in the continuous dialogue
with the health authorities.
Natalie Gauld, Director at Pharmacy Projects in New Zealand, explained
the positive experience of her country with a number of switches of medi-
cines from prescription to non-prescription status. She explained that only
accredited pharmacists with a completed training can supply emergency
contraception and that the mandatory pharmacists training is also used
elsewhere, e.g. for vaccines in Australia, hormonal contraceptives in Cali-
fornia or for patient group directions, e.g. trimethoprim (cystitis), oselta-
mivir (influenza) and sildenafil (erectile dysfunction) in the UK.
The unique reclassifi-
cation of vaccines
from prescription to
non-prescription sta-
tus in New Zealand
was explained by Ali-
son van Wyk, Head
of Professional Ser-
vices at Green Cross
Health.
Vincent Warnery
Natalie Gauld
Alison van Wyk
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The UK government policy
is to widen access to medi-
cines which enables best
use of healthcare professio-
nal resources and supports
patient empowerment
through self-care, stated
Sarah Branch, Deputy Di-
rector at the Medicines and
Healthcare products Regula-
tory Agency (MHRA) in the
UK. Branch said that this leading role is reflected in the streamlined MHRA
classification guideline which focuses on benefit/risk analysis, early discus-
sion with the regulators and early engagement with stakeholders.
The session then moved to the topic of falsification of medicines and pro-
vided an update on the work in Spain and on the European level. The Spa-
nish perspective on the implementation of the EU Falsified Medicines Di-
rective was given by Beln Escribano, Head of the Pharmaceutical Inspec-
tion and Enforcement Department at the Spanish Agency for Medicinal
Products and Medical Devices (AEMPS). Escribano highlighted that the
new requirements should effectively decrease the risks of falsified medici-
nal products, increase the quality of medicinal products and reinforce the
supply chain against falsified medicinal products including on-line supply
channels.
The new EU rules on safety features were explained by Stefano Soro,
Head of Unit Medicinal products quality, safety and efficacy at the Eu-
ropean Commission. The EU Falsified Medicines Directive introduces obli-
gatory 'safety features' to allow verification of the authenticity of medici-
nal products for human use ('unique identifier'). The European Commis-
sion prepared a delegated act on safety features which has been extensi-
vely discussed with the EU Member States. While prescription medicines
will have an obligation for the safety features, the OTC medicines shall not
bear the safety features unless they are at a serious risk of falsification,
explained Soro. OTC medicines with safety features will be included on a
so-called black list of exceptions. The European Commission foresees
that the new delegated act will be published in the Official Journal of the
European Union by the end of 2015.
Sarah Branch
Beln Escribano
Stefano Soro
Vincent Warnery, Alison van Wyk, Natalie Gauld, Sarah Branch, Beln Escribano, Stefano Soro
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Dr Liese was also wondering if there is a need for more European coordina-
tion of Health Technology Assessment and the possible future role of the
EMA in this respect. Regarding the future of the food legislation, Liese re-
ferred to the ongoing discussions on the new Novel Food Regulation as well
as to the pending issues related to the Claims Regulation such as nutrient
profiles and the scientific assessment of botanical health claims. According to
Dr Liese all health claims, including botanicals, should be evaluated by EFSA.
Concerning medical devices, Dr Liese shared his wish that the ongoing revi-
sion of the medical devices legislation will progress quickly and that the three
EU Institutions (European Commission, Council of Ministers of EU Member
States and the European Parliament) will find a reasonable compromise.
Perspectives for the future
Peter Liese, Member of the European Parliament, reflected on the future of the health care sector. Dr Liese
highlighted that the year 2015 marks 50 years of pharmaceutical legislation as the first directive related to
medicinal products was adopted in 1965. He raised important questions on the future of financing the
healthcare system in the long run and how to best manage the impact of significant therapeutic innovation
on health care budgets. In this context, self-care and consumer empowerment will play a key role.
Noel Wathion, Chief Policy Adviser at the European Medicines Agency (EMA),
acknowledged that important changes in the regulatory environment require
both regulatory authorities and pharmaceutical industry to continuously re-
view the impact on their day-to-day operations. There is a need for conti-
nuing dialogue to better understand expectations and needs in order for the
most cost-efficient approach to be developed, said Wathion. Particularly
challenging in this context are the new pharmacovigilance requirements and
all the work around the new IT systems.
Invitation to the 52rd AESGP Annual Meeting in 2016
The Conference was concluded
by the invitation of George Do-
kios, Executive Director of the
Association of the Greek Self-
Care Industry EFEX, to the 52nd
AESGP Annual Meeting which will
be held in Athens from 31 May
to 2 June 2016 .
George Dokios
Noel Wathion
Pieter Liese
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