European Union (EU) member states should have greater freedom to determine their own policies relating to early access to medical innovations, a UK report urges.
Reporting the conclusions of the Fresh Start Project inquiry into the EU impact on the UK life sciences sector, the study finds “growing hostility” to biotech within the EU, reflected in an increasing tide of anti-biotech legislation. This is having “a damaging effect on the EU bioscience economy, and risks condemning the EU – and by extension the UK – to the global slow lane in biotechnology,” warn study authors George Freeman MP, a UK government advisor on life sciences during 2011-13 and chair of the All-Party Group on Science and Technology in Agriculture, and Pawel Swidlicki, a researcher at Open Europe.
This regulatory hostility is having its most serious impact in agricultural research, they find, while in medicine “the story has been a much happier one, with the EU seen in the post-war years as an enlightened and progressive jurisdiction for investing in biomedical research.”
Nevertheless, the authors warn that recent trends have led to growing concerns from academic researchers, companies and medical charities that the EU is in danger of becoming increasingly unattractive for new technologies and disciplines such as stem cell and regenerative tissue science, genomics and genetic epidemiology and the use of clinical data in large-scale “BigData” studies to help drive stratified and personalised medicine.
The hostile environment is being driven by the growing influence of “anti-corporate and anti-capitalist” lobbyists and politician parties, who are unduly rewarded for their early influence by the structure and process of the EU decision-making process. There is also insufficient influence or effective representation of the individuals, charities and companies in the UK “doing so much to pioneer these emerging fields,” plus inconsistent and differential implementation and impact of EU legislation across different member states, they say.
The way forward requires a fundamental review and reform of the way EU policies are affecting the European and UK bio-economy sector, the authors recommend. ‘This should include a specific requirement that all EU policies comply with the overall policy of promoting the EU as a global power in bioscience,” they say.
And while the EU framework in biomedicine is well-established “and has a good reputation as a largely benign influence on life science investment,” more effective influence from the UK is needed to deal with potential new challenges and threats posed by the EU’s response to new technologies, they urge.
Commenting on the report, Steve Bates, CEO of the BioIndustry Association (BIA), described it as “well-researched,” and welcomed its call for more effective influence from the UK to shape the EU response to new technologies. “The UK is able to exert some influence over both EU and also global rules, although it has not always done so successfully,” he said.
However, Mr Bates added that the UK government “need not look to Brussels to boost the life science sector in the UK.”
“It could help life sciences companies in the UK by introducing a fully-funded early access to medicines scheme – which is within national competence,” he suggests, pointing out that this policy was included in the government’s own Strategy for UK Life Sciences two years ago and has been developed and recommended by the Medicines and Healthcare products Regulatory Agency (MHRA)’s Expert Group on Innovation in the Regulation of Healthcare.
