pharmaceuticals - information to patients and eu law dr. maria eva foldes european health law &...
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Pharmaceuticals - information to patients and EU law
Dr. Maria Eva Foldes
European health law & ethics summer course
Riga, June 2013
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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
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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
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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
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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
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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!
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Prohibited!
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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
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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
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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
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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
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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
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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
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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
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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!
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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
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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)
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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)
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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
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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)
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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!
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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
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How can we ensure
that information is used
to empower, not to
persuade patients?