PharmExec Blog

October Sees 'Tsunami of Lobbying and Legislation' in Europe

April might be – as T S Eliot suggested – the cruellest month, but for pharmaceuticals in Europe, this October is certainly a contender to win an award as the busiest month. When the penultimate day of the month offered a breakthrough agreement to start discussions between European Union ambassadors and the European Parliament on the new rules on clinical trials, it looked like the crowning moment of the thirty-one days. But there was more in store. On the very final day of the month, EU health officials released the long-awaited (five years since it was promised!) paper on the way ahead for ‘omics and personalized medicine.
Truly action to rival the most energetic soap opera. And that after a packed month of other health and pharmaceutical events contributing to the future shape of Europe’s medicines industry.
Among other things, it announced research funding of $14 million to standardize vaccine efficacy checks. The president of the European Commission made an unprecedented intervention at the World Health Summit to champion European Union health policy.
But it wasn’t all a story of unqualified successes. The radical scheme to allow patients in Europe to get access to cross-border healthcare had a very downbeat launch, because most member states have not yet put in place the national mechanism to make it work. And the EU belatedly confirmed the official death of a moribund proposal – mouldering since 2008 – to regulate information to the public on prescription medicines. Criticisms started to emerge of the European Medicines Agency’s plans for wider data transparency plan, and renewed arguments over its merits took place at the EU’s top court, ahead of the expected December dénouement when the agency will formalize its approach. And transparency issues continued to dog the prospect of agreement on new EU rules on clinical trials
Meanwhile, generics companies complained they were being squeezed by national pricing rules in the EU’s member states, biopharmaceutical researchers claimed they were suffering ‘alarming’ stagnation in Europe, the European Parliament said that new fees to be imposed on drug firms for pharmacovigilance are too high, the European Commission was accused of failing to understand the concept of patent protection, and health campaigners complained that EU health policy was tilted too far towards treatment and should re-focus on prevention.
Amid all this – and much, much more – it is hard to imagine how anyone can make their voice heard. Yet over recent days and weeks the invitations and announcements continue to pour in, seeking attention for tackling Clostridium difficile infection or chronic obstructive pulmonary disease (with the lure of a free spirometry test before their meeting), or for supporting the European Federation of Psoriasis Patients Associations, or for reviewing the EU’s upcoming research program and its role in promoting personalized medicine… and again, much, much more.
Is it any surprise, amongst such a tsunami of legislation and lobbying, that the European Public Health Alliance – itself a battle-hardened umbrella organization of health lobby groups – should be offering courses on how to ensure that a lone voice is heard? It is now advertising a ‘professional development program’ which provides guidance on health advocacy, “to train those new to the ’EU bubble’ to get an introduction to the European Union and more particularly to European health advocacy.”
It had to happen. It is a characteristic of any popular soap opera that the lead characters create their own spin-offs and start to appear in their own show. The healthcare sector in Europe is now spawning an industry of its own. Perhaps a sign of vigorous health.

By Peter O’ Donnell.

April might be – as T S Eliot suggested – the cruellest month, but for pharmaceuticals in Europe, October was certainly a contender to win an award as the busiest one. When the penultimate day of the month offered a breakthrough agreement to start discussions between European Union ambassadors and the European Parliament on the new rules on clinical trials, it looked like the crowning moment of the thirty-one days. But there was more in store. On the very final day of the month, EU health officials released the long-awaited (five years since it was promised!) paper on the way ahead for ‘omics and personalized medicine.

Truly action to rival the most energetic soap opera. And that after a packed month of other health and pharmaceutical events contributing to the future shape of Europe’s medicines industry.

Among other things, it announced research funding of $14 million to standardize vaccine efficacy checks. The president of the European Commission made an unprecedented intervention at the World Health Summit to champion European Union health policy.

But it wasn’t all a story of unqualified successes. The radical scheme to allow patients in Europe to get access to cross-border healthcare had a very downbeat launch, because most member states have not yet put in place the national mechanism to make it work. And the EU belatedly confirmed the official death of a moribund proposal – mouldering since 2008 – to regulate information to the public on prescription medicines. Criticisms started to emerge of the European Medicines Agency’s plans for wider data transparency plan, and renewed arguments over its merits took place at the EU’s top court, ahead of the expected December dénouement when the agency will formalize its approach. And transparency issues continued to dog the prospect of agreement on new EU rules on clinical trials

Meanwhile, generics companies complained they were being squeezed by national pricing rules in the EU’s member states, biopharmaceutical researchers claimed they were suffering ‘alarming’ stagnation in Europe, the European Parliament said that new fees to be imposed on drug firms for pharmacovigilance are too high, the European Commission was accused of failing to understand the concept of patent protection, and health campaigners complained that EU health policy was tilted too far towards treatment and should re-focus on prevention.

Amid all this – and much, much more – it is hard to imagine how anyone can make their voice heard. Yet over recent days and weeks the invitations and announcements continue to pour in, seeking attention for tackling Clostridium difficile infection or chronic obstructive pulmonary disease (with the lure of a free spirometry test before their meeting), or for supporting the European Federation of Psoriasis Patients Associations, or for reviewing the EU’s upcoming research program and its role in promoting personalized medicine… and again, much, much more.

Is it any surprise, amongst such a tsunami of legislation and lobbying, that the European Public Health Alliance – itself a battle-hardened umbrella organization of health lobby groups – should be offering courses on how to ensure that a lone voice is heard? It is now advertising a ‘professional development program’ which provides guidance on health advocacy, “to train those new to the ’EU bubble’ to get an introduction to the European Union and more particularly to European health advocacy.”

It had to happen. It is a characteristic of any popular soap opera that the lead characters create their own spin-offs and start to appear in their own show. The healthcare sector in Europe is now spawning an industry of its own. Perhaps a sign of vigorous health.

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