As the United Kingdom debate about whether to stay in the European Union becomes more bitter and intense, an insight into how EU membership impacts on medicines and pharmaceuticals has appeared from a British politician who was until recently the UK Government Adviser on Life Sciences, George Freeman. His view—which is less than rosy—is worth a glance.
There are benefits of membership, he concedes. He notes a "regulatory framework that has broadly served to liberalize trade within the single market while also maintaining high product standards." The plus side of the account also includes the fact that the UK has been able to exploit free movement and access to funding streams to build up its own strength in the sector. So, he says, it is easier to bring products to market across 28 member states on the basis of the same requirements. And the UK has gained as an international hub for life sciences. "As with financial services, the UK and London in particular is a gateway for international companies to the EU market" – as well as the location of the European Medicines Agency, and of the new EU patent court which will deal with pharmaceuticals and life sciences, once it is up and running.
But, he goes on, there are "daunting challenges on the horizon," and "the EU could not only hold back further expansion, but also threaten existing progress."
He is particularly anxious about the implications of the EU's bid to introduce new data protection rules. He argues that there has been a failure to understand why issues around personal data are so important in the context of life sciences. "It is necessary to appreciate the major shift taking place in medicine from the traditional ‘one size fits all’ model of ‘blockbuster’ drug discovery and development which has dominated the pharmaceutical sector in the post-war period to an increasing focus on ‘stratified’, ‘targeted’ and ‘personalized’ treatments," he points out in his report published last week.
In his view, the proposal for a comprehensive reform of the current data protection legislation - which dates from 1995 – "could be very damaging not only to business in general, but to life science companies and medical research charities in particular as it would hinder their ability to collect, store and share patient data."
He pinpoints the attempts to strengthen the privacy provisions that have been spearheaded by the lead member of the European Parliament responsible for piloting debates on this measure, the German Green, Jan Philipp Albrecht. These changes "would remove the current provisions and derogations that facilitate scientific research, making it impossible for researchers to access identifiable data without 'specific, informed and explicit consent.'" He quotes Science Europe, an umbrella organization of 51 national research institutions, that has warned that too rigid a focus on data protection will damage medical research in the EU, and that these amendments must be rejected. What is at stake, he says, is continued access to the uniquely comprehensive pool of patient data that the UK's national health system possesses, with its "potentially transformational impact on healthcare costs and outcomes in the UK, as well as the UK life science economy." At present, general practitioners sending patient records to a central database which can be exploited by universities and private companies for medical research. The new EU rules could torpedo that system.
Overall, Freeman is anxious that a raft of EU measures and interventions – ranging from the update of the clinical trials rules to inconsistent legal rulings on the validity of patents – are compounding uncertainty. "One of the key problems of European regulation in recent years is the creeping extension of jurisdiction of different parts of the EU, and the often inadvertent effect of confusing and contradictory measures sending mixed signals about the state of the European market, undermining investor confidence and market development."
It is a sobering reflection that that for pharmaceutical research in the UK, the intrinsic uncertainties of the exercise are being intensified not only by additional uncertainties about the legislative and regulatory environment in Europe, but also by the further uncertainties over the UK's destiny – and the growing possibility that the country may pull out of the EU entirely. Anyone with an interest in coherence and convergence rather than friction and fragmentation should take notice.