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Reflector is Pharm Exec's Brussels correpsondent.
Reflector reports on how the European pharma commitees and national associations are trying to shape the upcoming pharmaceutical package through informal
You can tell there's big money and big issues at stake in Europe when competing lobby groups start organising conferences in the European Parliament. The European Union's (EU) so-called 'Pharmaceutical Package' is now generating a raft of such meetings, proving that - despite its tediously detailed nature - this proposal has touched the hearts of the bean-counters as much as the boffins.
The package, consisting of hundreds of pages of minutiae designed to tighten up post-marketing monitoring, combat counterfeiting, and give patients more access to drug information, was proposed a year ago, and has been under formal discussion by member states and by MEPs ever since.
For instance, this month the Swedish EU presidency will put together reports on the progress made so far in the Council's working party on pharmaceuticals and medical devices (where member state officials are examining the package) on pharmacovigilance and on counterfeiting. It isn't the end of the process: the officials are still poring over the fine print of recording and reporting of adverse reactions and safety updates. But the work is, inch by inch, going forward.
Similarly, the Parliament is conducting its own assessment of the proposals through its own complex structures of committees, political groups and national affiliations. The first days of November saw centre-right Portuguese MEP Regina Bastos pushing ahead with the discussion of combating counterfeiting in the committee on internal market and consumer protection, and UK socialist Linda Mcavan driving the pharmacovigilance proposals through the committee on environment and public health.
But it is not the routine formal discussions that reveal the clash of power interests - and the attitudes adopted by the different segments of the European pharma industry - so clearly as the informal recruitment of the Parliament's debating chambers and of MEPs to promote one or another point of view, often over a buffet of limp sandwiches and tepid cocktails.
It was safety communications company Aegate that jumped on the bandwagon first, with a conference on counterfeiting that allowed it to show off how useful its system could be for the whole of Europe. It managed to get the leading MEP on this subject onto its panel - the freshly-elected left-wing Marisa Matias from Portugal - as well as an older hand, liberal MEP Jorgo Chatzimarkakis from Germany.
November's crop of similar events already includes a conference in the Parliament's press room at which European research-based manufacturers will have a chance to give "a hands-on demonstration of the anti-counterfeit pilot coding project for medicines" that they are promoting as a possible pan-European solution. Arthur Higgins, CEO of Bayer HealthCare and president of the European Federation of Pharmaceutical Industries and Associations (EFPIA), will appear alongside French centre-right MEP Franoise Grossette, who has shown some sympathetic understanding of the innovative industry in the past.
Just a few days later the generic manufacturers will parade their case, hosted by Bulgarian liberal MEP Antonia Parvanova and again featuring Marisa Matias.
Greg Perry, director general of the European Generic Association will be able to use the platform for advancing his members' demand for "securing the integrity of the supply chain in a cost-effective way" - in other words, imposing the fewest new requirements as possible on generic medicines. Alongside him, Martin Fitzgerald of the European full-line wholesalers association, GIRP, will doubtless echo the call for measures that do not require new layers of administrative obstacles for his members.
The arguments will run through to next spring and beyond, and the counterfeiting proposals will provide a battleground on which brand-name companies and full-line wholesalers will aim to squeeze parallel importers and unlicensed traders out of the supply chain, generic manufacturers will aim to dodge being hit by costly and - they believe - unnecessary new labelling requirements, and pharmacists will aim to demonstrate that they are the indispensable link in delivering safe medicines. Ripostes from parallel traders can be confidently expected too. The prospect is of plenty more lengthy speeches in limp sandwich receptions during the winter.