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Brussels' progress

To the casual observer, legislative developments at the EC may seem slow, but much has been achieved in recent times

Conveyor beltFor Brussels healthcare policy watchers, the last couple of years have been a rapid and exciting rollercoaster ride. Those tracking the progress of various proposals, committee by committee, question by question, amendment by amendment (and there are many who do), have found these rather exciting times. For those not tuned to the 'Brussels channel', the pace of progress may have appeared somewhat more pedestrian, but as Einstein observed, time is relative to the observer. From a Brussels perspective, I believe rather a lot has happened in a relatively short space of time.

Unsurprisingly, it has been the so-called 'pharmaceutical package', launched by outgoing Enterprise and Industry Commissioner Gunter Verheugen, that has captured the wider imagination.

However, the initial high expectations for the proposals, coupled with repeated delays to their launch, were somewhat undermined by other developments that would impact the industry. These included the anti-competition probe into industry practices and restructuring of the Commission, with primary responsibility for pharmaceuticals passing from DG Enterprise to DG Health and Consumer protection.

These were followed by a dramatic and unexpected financial crisis triggering widespread cost containment measures in healthcare, all of which I see as the basis of a heady mix for industry.

Although the proposed legislation was described as a package, this only provided a convenient shorthand; the reality was always going to be rather different. There was no real coherence to the package once it left Mr Verheugen's office; the individual components would be treated as separate legislative proposals. However, the size and scope of the measures, coming as they did at one time, rather overshadowed the fact that there was other key legislation already in train that could also prove pivotal for industry, which was not so conveniently labelled.

Indeed, arguably one of the most important debates that has taken place recently, from the industry's perspective, is the revision of the legislation on the protection of laboratory animals. The original directive dated back 25 years and the inevitable review process had been a source of potential concern for industry. Despite persistent criticism, animal studies remain a small but indispensable part of biomedical research. They are vital in developing fundamental biological knowledge and I believe that restricting their use unnecessarily in Europe would run the risk of creating an environment which would make this kind of research much more challenging.

Given that complete replacement of animals in research is not possible, this scenario could drive investment to other regions. The irony was that laboratory animal welfare standards in Europe were already the highest in the world, in a great part due to the efforts of the industry; it would have be a strange twist if the revised legislation had driven research to other regions, where, arguably, animal welfare is not so well monitored. Fortunately, the European Parliament finally adopted a text that struck a balance between improving welfare and maintaining Europe's medical research. Although it now has to be adopted into national legislation, I think it represents a welcome development for the industry.

Little substance
Furthermore, there was also that high-profile anti-competitiveness investigation into the pharmaceutical sector. Madame Kroes, the then Competition Commissioner at the time, was the architect of the inquiry. She railed against the industry in quite fiery fashion at the publication of the final report, but in reality I feel the inquiry found little of substance, and generated more heat than light. With Madame Kroes having moved to become Commissioner for the Digital Agenda, it remains to be seen whether her successor at Competition, Joaquín Almunia, will demonstrate similar enthusiasm for the task.

As for the elements of the package themselves, there has been clear progress recently. The proposals on pharmacovigilance, which were always likely to be the least contentious, were broadly welcomed and it was little surprise when they became the first element of the three to be adopted. This move will define the roles and responsibilities for the key parties more clearly and will develop and strengthen the Community pharmacovigilance database, EudraVigilance, making it the single point for receipt of pharmacovigilance information. In addition, patients will be able to report suspected adverse reactions directly. While the implementing measures may require careful consideration, it is generally seen as a positive and much needed overhaul of the existing legislation.

On the 'information to patients' dossier, there has been slow but significant progress. In September, the Environment, Public Health and Food Safety (ENVI) committee adopted the report by an unexpectedly large majority. The vote represented a significant step forward, underpinning patients' rights to information. It also recognised the industry as a valid partner in the provision of medicines information to citizens, albeit with stringent rules for approval and monitoring of the information. This was followed in early December, 2010, by adoption by the full European Parliament, again by a large majority. Considering earlier opposition, this represented a fairly strong shift in opinion. In practice, nothing changes immediately; this remains a competence of the individual Member States. However, this sends a signal to those Member States to resume their debate on the legal proposals, which they paused in June 2009. It would be unrealistic to ignore the fact that this dossier is likely to face continued resistance, with a number of countries determined not to engage on this topic.

No reluctance
On the third element, there remains the hope that a final agreement can be achieved between the relevant EU institutions soon. However, things are moving slowly. This does not indicate a reluctance to see such legislation; on the contrary, the ENVI committee in the European Parliament adopted the rapporteurs draft report by 51 votes to zero back in April 2010. However the Parliament and Council are still debating a number of controversial issues, including the scope of new legislation, the nature of proposed safety features (eg. questions on technology, control, confidentiality, costs) and the inclusion of internet pharmacy sales, areas that some Member States remain reluctant to discuss. Adoption and implementation will largely depend on the informal discussions between the European Parliament and the Council.

So, despite external appearances, a lot has changed, much has been achieved, and a large proportion of the proposed legislation has been approved or is moving towards its conclusion, at least as far as Brussels is concerned. However, as always, the details will warrant careful perusal. What will happen when matters are discussed in Council, or proposals need to be transposed into national legislation, are separate issues. On balance, however, the outcome could have been much less positive on so many fronts.

The Author
Colin MacKay is director, communication and partnerships, at EFPIA

To comment on this article, email

26th January 2011


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