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02-Dec-2010

Pharma Advertising and the EU

Pharma Advertising and the EU

Summary

As a result of a vote taken in the European Parliament earlier this week, patients in the European Union will receive improved information on prescription drugs, in addition to being protected from some of the more potentially exploitable clauses of the Commission’s proposed Directive on Information to Patients.
Last Updated: 02-Dec-2010

As a result of a vote taken in the European Parliament earlier this week, patients in the European Union will receive improved information on prescription drugs, in addition to being protected from some of the more potentially exploitable clauses of the Commission’s proposed Directive on Information to Patients. Specifically, and in contrast to proposals put forward by the Commission, the Parliament’s version of the bill makes it mandatory for drugs companies to provide both adequate information about drug characteristics on packaging and labeling, as well as to provide detailed drug assessment reports for all of their products. Moreover, the Parliament’s proposals also eliminate any potential grey areas related to the advertising by extending the existing ban on pharmaceutical advertising to print as well as visual media.

Critically, an amendment exempting information given by GPs and pharmacists from these rules has been stripped from the proposals, much to the relief of consumer groups such as the European Consumers Organisation (BEUC). Speaking ahead of the vote, Monique Goyens, director-general of BEUC said: ''The pharmaceutical industry should not use the doctor's office and pharmacies to promote their products''. The changes were carried unanimously by Parliamentarians.

The MEP responsible for the drafting of the Parliament’s reports, Swedish MEP Christofer Fjellner said: “The most important thing we did during this process was to change the focus of the whole legislation from the rights of pharmaceutical companies to spread information to patients’ right to get the information they need and want”. Indeed, many other commentators and MEPs have heralded the vote as the victory of patients’ rights over those of industry. Hence, to what extent do lobbyists truly influence the Parliament and to what degree are Parliamentarians free to act independently of these potential constraints?

Since the implementation of the co decision procedure as part of the Maastricht Treaty in 1993 – and its strengthening in the Treaty of Nice in 1999 — the role and relevance of the European Parliament in EU lawmaking has increased markedly. Now known simply as the "ordinary legislative procedure", and applicable to the majority of policy areas, the Parliament now finds itself with the genuine power to veto legislation.

Unsurprisingly then, since the EU’s adoption of the co decision procedure, the relevance of the European Parliament for lobbyists has grown substantially. Overall, current figures from the Parliament’s Register of Lobbyists lists just over 3300 long-term lobbyists and just short of 2000 registered organisations. Specifically in the case of big pharma, while exact figures are hard to find, the largest organisation, the European Federation of Pharmaceutical Industries and Associations (EFPIA), represents over twenty of Europe’s leading pharmaceutical companies, including GlaxoSmithKline, AstraZeneca and Eli Lily. And while the Commission remains the foremost target of these pressure groups as the primary initiator of EU legislation, the Parliament’s increased power in legislative decision making dictates an increased response from Brussels’ lobbyists.

Yet, as much as the power of lobbyists in Brussels is unquestionable, what this most recent vote demonstrates above all else is the freedom of MEPs to act independently when they choose to. And critically, to put the interests of the peoples of Europe first and the European capital’s lobbyists second. In the end, every system of democratic governance is susceptible to the influence of pressure groups. Sometimes these take the form of NGOs, think tanks or national associations, but more often European trade federations, who make up 32% of all lobbyists and interest groups in the case of the European Union. In a system of democracy, there is nothing fundamentally wrong with such a system. Indeed as some commentators have argued, the mobilization of interests is a fundamentally democratic concept that goes at least some way to eliminating the EU’s so-called ‘democratic deficit’. And not always do said interests take the form of monolithic companies, big pharma or otherwise.

Commenting after the vote, Brian Ager, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA) called the vote “a step in the right direction”, but warned that “To achieve real progress for patients, it is vital that any new legislation provides a viable legal framework. It should not require added and unnecessary bureaucracy; instead it should build on existing best practice within the EU”. Mr. Ager also stressed that it was not the intention of the EFPIA to ‘push’ information onto the public, but rather to ensure that their own demands for product information are met.

In the end, MEPs will take their own decisions and the views of lobbyists are combined with pressure from constituents, Parliamentary groupings and other sources to produce a final judgment. And as this most recent vote demonstrates, seldom are Parliamentarians truly ‘beholden’ to lobbyists. The amended version of the proposals will now be sent to the Council of Ministers for a final vote, to be held on December 6th.