Transcript Slide 1

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 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
Medicinal products as goods on the internal market
Main regulatory objectives pursued by the EU:
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Ensuring proper functioning of the internal market, and
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Promoting public health and ensuring the safety of patients, doctors, etc.
Directive 2001/83/EC - the Community code on medicinal products for human use
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Prescription-based medicines
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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:
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Inadequate communication of risk information
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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 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!
Prohibited!
Commission proposal: Background - I
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2001 – Commision proposal to allow for consumer-directed advertising on
HIV/AIDS, diabetes & asthma medicines rejected by Parliament & Council
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2002 – Parliament asked the Commission to prepare a consumer information
strategy on medicinal products and other treatments
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2005 to 2008 - High Level Pharmaceutical Forum: quality principles
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2007 – DG Enterprise: report on current practices on information provision & public
consultations
Background - II
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2008 – DG Enterprise: proposed Directive on information (‘Verheugen proposal’)
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2009 – The ‘Pharma package’ is taken over by DG Sanco
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2010 – 78 amendments by Parliament to the DG Enterprise proposal
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2011 – Revised Directive proposal by DG Sanco
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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
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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
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The “Pull, not push” principle:
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Empower patients to access information if they choose to do so
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Safeguard patients from unsolicited information
Proposed changes – type of information provided to the general public
Mandatory
Permitted
Labelling
Package changes, prices
Package leaflets
Information on human health & disease IF no
reference to specific medicines
Summary of Product Characteristics
Instructions for use with technical images
Public assessment reports drawn up by
authorities
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
Not contradict approved information (SmPC,
package leaflet, labelling)
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
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:
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Control of information at the time of registration
Monitoring of subsequent information
Adopting sanctions for non-compliance
User
Identification
Links to
unregistered
sites
Unsolicited
materials
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:
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Prohibiting misleading, inaccurate, unfounded information
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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
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Emphasis on the risk to harm public health
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Emphasis on the purpose & content of the message (Damgaard, MSD Sharp):
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Messages designed to promote prescription, supply, sale or consumption of medicines =
advertising
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Messages with no promotional intent = NOT advertising
Online materials (MSD Sharp):
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NOT advertising if based on the “pull” principle - i.e. require search by users
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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?