Pharmaceuticals - information to patients and EU law

Dr. Maria Eva Foldes

European health law & ethics summer course

Riga, June 2013

European Commission (February 2012):

Amended proposal for a Directive on information to the general public on medicinal products subject to medical prescriptionCOM(2012) 48 final

Amended proposal for Regulation (EC) on information to the general

public on medicinal products subject to medical prescription COM(2012) 49 final

http://ec.europa.eu/health/human-use/information-to-patient/index_en.htm

Medicinal products as goods on the internal market

Main regulatory objectives pursued by the EU:

• Ensuring proper functioning of the internal market, and

• Promoting public health and ensuring the safety of patients, doctors, etc.

Directive 2001/83/EC - the Community code on medicinal products for human use

- Prescription-based medicines

- Over-the-counter (OTC) medicines

Advertising of medicinal products – Directive 2001/83/EC:

“Any form of door-to-door information, canvassing activity or inducement

designed to promote prescription, supply, sale or consumption of medicinal products”

Including:

– advertising to the general public & to persons qualified to prescribe/ supply medicines

– visits by sales representatives

– supply of samples

– inducements (gifts, offer or promise of benefits or bonuses except those of minimal value)

– sponsorship of promotional meetings & scientific congresses

USA – experience with DTCA of prescription medicines

Most common violations of rules:

• Inadequate communication of risk information

• Over-statement of benefits

Lack of fair balance between benefits & risks Melillo (1999); Lexchin & Mintzes (2002)

ProCon.org

Information on & advertising of prescription medicines to the public:

current EU rules

Type of communication by the industry

Prescription medicines

Information provision - mandatory Package leafletsLabelling

Information provision - permitted Package changesPricesInstructions for useVaccination campaigns conducted by the industryInformation on human health & disease IF no reference to specific medicines

Advertising to consumers (DTCA) Prohibited – absolute ban!

Prohibited!

Commission proposal: Background - I

• 2001 – Commision proposal to allow for consumer-directed advertising on

HIV/AIDS, diabetes & asthma medicines rejected by Parliament & Council

• 2002 – Parliament asked the Commission to prepare a consumer information

strategy on medicinal products and other treatments

• 2005 to 2008 - High Level Pharmaceutical Forum: quality principles

• 2007 – DG Enterprise: report on current practices on information provision & public

consultations

Background - II

• 2008 – DG Enterprise: proposed Directive on information (‘Verheugen proposal’)

• 2009 – The ‘Pharma package’ is taken over by DG Sanco

• 2010 – 78 amendments by Parliament to the DG Enterprise proposal

• 2011 – Revised Directive proposal by DG Sanco

• February 2012 - Latest version of the proposed Directive by DG Sanco

Commission proposal – objectives:

Ensure proper functioning of the internal market for medicines

Protect the health of individuals by:

• Empowering patients to make informed treatment choices

• Promoting equal access to high quality, objective, non-promotional information

• Enhancing the rational use of medicines

Continue to prohibit DTCA of prescription medicines

Methods proposed

• Increase the role of the industry in direct-to-patient information; establish:

– What type of information must & what may be made available by the industry

– What communication channels are permitted

– Quality standards for information content & presentation

– Monitoring mechanisms & sanctions with specific rules for internet

• The “Pull, not push” principle:

- Empower patients to access information if they choose to do so

- Safeguard patients from unsolicited information

Proposed changes – type of information provided to the general public

Mandatory Permitted

Labelling

Package leaflets

Summary of Product Characteristics

Public assessment reports drawn up by authorities

Package changes, prices

Information on human health & disease IF no reference to specific medicines

Instructions for use with technical images

Vaccination campaigns - information on efficacy, adverse effects, contra-indications as approved

Environmental impact

Pharmaceutical tests, pre-clinical & clinical trials

Summary of frequent Q&A

Independent third party statements – if they declare benefits received from the industry

Communication channels

Internet websites – emphasized as the main channel

Written answers to specific information requests received from individuals

Printed materials issued on individuals’ request or through health professionals

Printed

press

Quality standards for information

Objective, unbiased - stating benefits & risks

Meeting patients’ needs & expectations

Evidence-based, verifiable, up-to-date

Reliable, factually correct, not misleading

Understandable, legible

Accessible to persons with disabilities

State the source, authors, references

Not contradict approved information (SmPC, package leaflet, labelling)

Include contact address for marketing authorization holder & competent authorities

Indicate that the product is prescription-based

Indicate that information intends to support, not replace, patient-doctor relationship

Include the latest package leaflet

Monitoring

1. Member States - approval of information prior to dissemination

BUT – Member States may rely on other mechanisms of control if prior

control is not compatible with constitutional rules on freedom of expression/ press

2. European Medicines Agency - prior vetting of information on medicines authorized under the Community procedure

Voluntary control by industry self-regulation is no longer an option!

Monitoring: rules for internet-based information

Pharma companies must register Internet sites with national competent authorities before making them available to the public

The Member State where the site is registered is responsible for:• Control of information at the time of registration • Monitoring of subsequent information• Adopting sanctions for non-compliance

User Links to Unsolicited

Identification unregistered materials

sites

The European Court of Justice on advertising of medicinal products - I

The essential aim of Directive 2001/83/EC is to safeguard public health by:

• Prohibiting misleading, inaccurate, unfounded information

• Requiring the provision of essential information (C-249/09 Novo Nordisk)

Public health protection takes priority over freedom of information

(C-421/07 Damgaard)

The ECJ on advertising of medicinal products - II

Statements by independent third parties may constitute advertising even if not disseminated in the context of a commercial or industrial activity (C-421/07 Damgaard)

Even if carried out by a third party, advertising of medicines is still liable to harm public health

(C-421/07 Damgaard)

Selective & otherwise manipulated information is prohibited! (C-316/09 MSD Sharp)

Prize draws, gifts, samples for the public are prohibited even for OTC medicines!

(C-374/05 Gintec)

The ECJ on the distinction between advertising & information

Emphasis on the risk to harm public health

Emphasis on the purpose & content of the message (Damgaard, MSD Sharp):

– Messages designed to promote prescription, supply, sale or consumption of medicines = advertising

– Messages with no promotional intent = NOT advertising

Online materials (MSD Sharp):

– NOT advertising if based on the “pull” principle - i.e. require search by users

– Advertising if based on the “push” principle - i.e. unsolicited materials

No definition for non-promotional information

What type of medicine information do patients seek?*

– Potential side effects (Melnyk et al, 2000, Newby et al, 2001, Nair et al, 2002)

– Efficacy of a given medicine in a certain disease (Newby et al, 2001, Nair et al, 2002)

– Duration and cost of treatment and the reasons why it was prescribed to them (Nair et al, 2002)

*Literature review by Närhi (2006)

Impact of written medicines information

Inconsistent evidence on impact on patients’ treatment knowledge & choices

Raynor et al (2007): gaps in the evidence base concerning:

• Effectiveness of benefit-risk information

• Effects of information at different phases of treatment

• Use of information by consumers with special needs

Impact on health outcomes is largely unexplored!

Prescription medicines – final remarks on the Commission proposal

Emphasis on internet-based information

BUT

Little is known about impact on:• Patients’ treatment knowledge & choices• Health outcomes

Consumers’ need for comparative information is not addressed

No definition for non-promotional information

How can we ensure

that information is used

to empower, not to

persuade patients?