Out-Law News 5 min. read
21 Jan 2014, 10:21 am
The report, which assesses the EU's impact on the UK life sciences sector (49-page / 1.37MB PDF), highlighted particular concerns with how planned reforms to the trading bloc's data protection regime could affect medical research. It also said there is an "anti-scientific bias" in the rulings of the EU's highest court, the Court of Justice of the EU, which presents a risk to UK life sciences businesses.
The report was created by the Fresh Start Project, a group focused on achieving reforms to the UK's relationship with the EU. Former adviser on life sciences to the UK Government, George Freeman MP, and Open Europe researcher Pawel Swidlicki wrote the report.
"Whilst the EU has until recently been a largely progressive and enlightened force for progress through the appliance of science and technology in the life sciences, especially in biomedicine, the rising tide of hostility to corporate biotechnology, expressed through increasingly powerful lobby groups with increasing influence in the EU legislative process, has started to have a serious impact on the EU and UK’s ability to secure investment," the report said.
"Unless serious steps are taken to tackle it, the EU – and by extension the UK – can expect a continued decline in life science investment and influence in this most exciting of global sectors. This would condemn the EU and its member states to a backseat of the biotechnology revolution transforming the life prospects of billions of our fellow citizens, allowing others to reap the economic dividend which could have been ours," it said.
The report acknowledged that EU membership does offer benefits, such as access to both European and global markets, cross-border collaboration, and access to EU research funding.
It also said that companies operating in the pharmaceuticals and med-tech sector benefit from a harmonised regulatory framework that facilitates access to a market in 28 member states. However, companies still need to deal with pricing and reimbursement in each individual member state, said life sciences industry regulatory expert Paul Ranson of Pinsent Masons, the law firm behind Out-Law.com
In contrast, the inquiry on which the report is based found that membership of the EU was curtailing the UK’s scope to exploit the global growth opportunities in agricultural biotechnology and in particular the opportunities in genetically modified (GM) foods. The main concern expressed was that the EU is adopting too precautionary an approach to regulation in this area which may be disproportionate to the risks. This is putting the European, and consequently the UK’s, agricultural biotechnology market at a significant competitive disadvantage, the report said.
Policymaking in the EU "unduly rewards" lobby groups that can exert an "early influence" in the law making process, the report said. The views of pioneering individuals, charities and companies in the biotech industry are underrepresented or the groups' influence is limited, it added.
"However, possibly the biggest barrier to entry for GM foods in the UK and many other EU countries at the moment is the potential lack of acceptance by consumers," legal expert in the life sciences industry Helen Cline of Pinsent Masons said. "Many customers remain unconvinced that genetic modification of plants and animals should be pursued. For GM foods to be a commercial success in Europe customer attitudes to GM will need to change. The general public must be reassured and have confidence that the necessary rules and safeguards are in place and effectively enforced. They need to see that industry is prepared to enter into the debate on the ethical issues and deal with other public concerns."
In the area of medicine specifically there is growing concern that the EU is losing its attractiveness as an area in which to innovate, for example by practicing "stem cell and regenerative tissue science" or using "clinical data in large scale ‘BigData’ studies to help drive stratified and personalised medicine", it said.
The direction that reforms to EU data protection rules appears to be going in could also hamper medical research in the UK if proposals on the table are introduced, the report warned. In particular, forcing businesses to obtain "specific, explicit consent" from individuals for the use of their personal data in research projects would be "unworkable" and possibly "illegal", it said.
"The amendments will put at risk significant European investments in genetics, cohort studies and biobanks, cancer registries and the use of routinely collected healthcare data," the report said.
The report's authors said that individual EU member states should be able to set their own rules on data protection and added that privacy protections could be strengthened in other ways without impinging on medical research projects.
Data protection law specialist Marc Dautlich of Pinsent Masons, the law firm behind Out-Law.com, said that rules on the processing of personal, biomedical information for the purposes of medical research should not be drawn purely from data protection laws.
"Research in this field is a very important endeavour," Dautlich said. "How to balance individual rights against the wider societal benefits of conducting such research is going to be a defining question for 21st century ethics in medicine. The issue is where you draw the line between cases in which consent to processing is the right legal basis and where there is an overriding public policy reason to justify pursuing research without needing the permission of individuals to use their data. That demands a very nuanced and difficult discussion about how to balance the competing interests of privacy and the advancement of medical science."
Dautlich said that a consultation recently held by the Nuffield Council on Bioethics addressed how advances in technology allow for more linking and use of biological and health data and sought views on how ethical issues and matters of privacy, confidentiality should be balanced with public interest issues in furthering such research. The consultation closed on 10 January.
Dautlich also said that the Caldicott review on NHS data handling last year contained recommendations on how best to balance the issues within a coherent governance framework. He said that public perception and trust on the handling of their health data had been negatively affected by the track record NHS Trusts have in keeping that data safe. Improvements in information governance within the NHS might help ease the public's privacy fears, he said.
Where consent is the right legal basis for processing personal data, as, broadly speaking, is the case in very many current research projects, the nature of that consent process is worthy of careful consideration, Dautlich added. In many projects, there would appear to be a need for continuing engagement with the public on how researchers are developing the use of their data as the research develops, he said.
"In such cases, it is misleading to view consent as a one-off event," he said. "In such cases, consent is an ongoing process. Researchers do not always know what they are going to find and so the purposes for which they collect data are often, rightly, loosely defined and then change during the course of a project. Researchers need to have ongoing interaction with research subjects to ensure they have up-to-date consent."
Dautlich also said that the internationalisation of research requires policy makers around the world to collaborate to make sure that there are more easily navigable rules governing data privacy and security when the data is being used within medical research projects, so that there are not unnecessary obstacles to such projects.