UK minister lobbied EU for lighter regulation of drugs and devices

The UK government has been lobbying the European Commission to adopt a more relaxed approach to regulating drugs, devices, and food, a letter seen by The BMJ has shown.

George Freeman, the UK life sciences minister with responsibilities including the Medicines and Healthcare Products Regulatory Agency and the National Institute for Health and Care Excellence, wrote to the European Union’s (EU) research, science and innovation commissioner, Carlos Moedas, late last year to urge him to “tackle the increasingly precautionary ‘anti-science’ trend in EU legislation” that he said was stifling innovation.

Freeman said that regulation needed to change “to attract significant inward investment, attract industry collaboration, and support new business growth.”

Citing a 2015 report from financial consultants Capital Economics, Freeman wrote that the “bioeconomy”—which included medicine, food, biotechnology, and agrichemicals—provided 600 000 jobs in Britain and contributed £36.1 billion (€45.6bn; $51.2bn) to the British economy (2% of the total). The sector needed the EU to “embrace these opportunities as well,” added Freeman, who is campaigning for the UK to remain in the EU.

To protect investment by medical device companies in the EU, Freeman advised against broadening the range of products that need to undergo premarket scrutiny. He also argued against “strict controls around the provision of genetic testing services.”

The European Parliament is currently considering proposals that genetic tests should be conducted by qualified medical professionals and only once full consent had been given.

“This would severely restrict patient access to all types of genetic testing,” Freeman said.

Martin McKee, professor of European public health at the London School of Hygiene and Tropical Medicine, told The BMJ that these attempts to water down public protection highlighted the need to stay within the EU.

“Once again the European Union is prioritising patient safety over the narrow interests of industry, protecting us from the policies pursued by our own government. We give up this protection at our peril,” he said.

As well as supporting the device industry, Freeman said that the EU and the UK needed to remain an “attractive environment for pharmaceutical companies . . . to develop and launch new medicines.”

Specifically, he said that the time it took to grant a drug licence “should be shortened” and listed a number of ways in which the assessment of “innovative medicines” could be speded up.

To send a “positive signal to industry,” Freeman said that there needed to be a change to EU legislation to allow a broader range of drugs to be given “conditional marketing authorisation” with “presumed positive benefit-risk assessments.”

Currently, the European Medicines Agency allows drugs on to the market if they address “an unmet medical need” and “the benefit of immediate availability outweighs the risk of less comprehensive data.”

McKee, again, urged caution. “While it is important not to stand in the way of progress, history reminds us of the importance of the precautionary principle. The reasons for establishing sound safeguards for new medicines still exist and we should think very carefully before placing expediency before patient safety,” he told The BMJ.

Freeman also questioned the number and kind of data needed for the European Food Safety Authority to assess the risk of genetically modified (GM) foods.

“The regulatory compliance costs for GM products are already considerable, and if applicants are faced with unnecessary burdens it will act as a further barrier to innovation,” he said.

Another market Freeman wanted to protect was “nutraceuticals”—foods that are purported to have health benefits. He said that the current restrictive authorisation process on health claims “is in danger of having a negative effect on innovation.”

“The EU has a phenomenal opportunity to be in the forefront of innovation and this fast-emerging sector with companies like Danone, Nestlé, and many others in the food and medicine field. We believe that in the years ahead there will be a growing overlap between food and medicine in a range of areas,” he said.