1. Pharmaceuticals - information to patients and EU law Dr. Maria Eva Foldes European health law & ethics summer course Riga, June 2013

2. European Commission (February 2012): Amended proposal for a Directive on information to the general public on medicinal products subject to medical prescription COM(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

3. 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

4. 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

5. 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

6. Information on & advertising of prescription medicines to the public: current EU rules Type of communication by the industry Prescription medicines Information provision - mandatory  Package leaflets  Labelling Information provision - permitted  Package changes  Prices  Instructions for use  Vaccination campaigns conducted by the industry  Information on human health & disease IF no reference to specific medicines Advertising to consumers (DTCA)Prohibited – absolute ban!

7. Prohibited!

8. 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

9. 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

10. 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

11. 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

12. Proposed changes – type of information provided to the general public MandatoryPermitted 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

13. 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

14. 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

15. Monitoring 1. Member States - approval of information prior to dissemination BUT – Member States may rely on other mechanisms of control if p rior 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!

16. 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

17. 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)

18. 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)

19. 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

20. 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)

21. 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!

22. 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

23. How can we ensure that information is used to empower, not to persuade patients?