Part of the reason could be because ideas around DTC have not been raised in isolation and make up the so-called "pharmaceutical
package" currently being discussed at EU level.8 The package includes measures for tackling counterfeit medicines and improving pharmacovigilance, which have been widely
welcomed. However, it also includes measures for disseminating information to patients, which has alarmed opponents of DTC.
However, the driving force for these changes is patients, who feel that they still have difficulties in accessing medicines'
information. In their minds, the focus for policy change is on the provision of information rather than promotion. It is widely
agreed that information on medicines in Europe is fragmented, which puts patients at a disadvantage in receiving healthcare.9
At present, Article 88 of Directive 2001/83/EC — a set of rules for pharmaceutical advertising — prohibits DTC advertising
of prescription-only medicines, but interpretations of the directive can vary between EU member states.9 Presumably, those who back a revision to the way information is communicated in Europe believe some sort of standardisation
is needed and that some aspects of DTC could be acceptable if they benefit the patient.
The lack of clarity over what is being proposed for Europe has caused a number of delays with the EC's Directive on Information
to Patients. In November 2010, some progress was made with potential promotional routes for information being specifically
rejected;9 MEPs backed measures to ban information on prescription drugs being made available on radio and television, and also extended
the ban to print media. At the first reading of the legislation, MEPs supported the provision of "objective information on
a drug's characteristics and the treated disease or condition", but rejected "unsolicited information or disguised advertising".8
What the current legislation does acknowledge is that pharma companies know their products best. In line with this, the legislation
will allow companies to provide basic information on product characteristics, labelling and package leaflets, as well as an
accessible version of a drug's assessment report. However, it will be up to individual member states whether or not to extend
this to include other non-promotional information, such as pricing details and packaging changes.
Providing more information may enhance the role that European patients play in healthcare. For example, there are hopes that,
by being better informed, patients will be able to contribute towards pharmacovigilance measures by reporting their adverse
effects directly to national authorities.10
The European Parliament has introduced draft legislation to facilitate the introduction of specialised pharmaceutical
portals that would contain an array of medical information on medicinal products and their proven side effects. These would
also instruct patients on how to report adverse events using these sites and other means. The national portals will also be
linked to EU ones so that information is not lost across the region. At the moment, one of the alleged weaknesses in the EU
is that information on an adverse reaction at national level may not be recorded at a regional level, thereby not providing
a full picture of a product's potential side effect profile.
Summary
In Europe, patient demand for increased access to information on medicines looks likely to result in pharma companies being
permitted to directly communicate with patients. However, it is difficult to see DTC evolving into the advertising style typified
by the US market, particularly as the European pharma industry itself has been careful to distance itself from such an approach.
The culture and market conditions in Europe remain very different to those in the US and so it unlikely that DTC advertising
would ever have a receptive audience.
References
1. European Public Health Alliance, "Direct-To-Consumer Advertising — for or against?" (2008).
http://www.epha.org/
2. F. B. Palumbo and C.D. Mullins, Food and Drug Law Journal, 57(3), 423–443 (2002).
3. M.A. Gagnon and J. Lexchin, PloS Medicine (January, 2008).
4. P. Kelly, Health Affairs (April, 2004). http://content.healthaffairs.org/
5. GSK, "Direct-to-consumer advertising" (2010).
http://www.gsk.com/
6. ABPI, "ABPI welcomes European Parliament decision on DTC" (2002).
http://www.abpi.org.uk/
7. Inpharm, "DTC: the new philosopher's stone?" (2003).
http://www.inpharm.com/
8. Scrip 100, Reform on the Agenda (2010).
http://www.scrip100.com/
9. PharmaTimes, "MEPs vote for pharma to 'inform, not advertise'" (2010).
http://www.pharmatimes.com/
10. European Parliament, "Protecting patients: EU to upgrade medicine safety monitoring. European Parliament" (2010).
http://www.europarl.europa.eu/
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