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UK promises 67-day Brexit licence for biologicals and biosimilars

Out-Law News | 05 Oct 2018 | 9:29 am | 2 min. read

Manufacturers of new biological or biosimilar medicines could obtain a licence to sell their medicines in the UK within 67 days of making an application under a new scheme aimed at minimising the impact of a 'no deal' Brexit.

The new "targeted assessment" scheme would be open to "novel products containing new active substances or biosimilar medicines" that have already been scrutinised and endorsed by the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP), according to a consultation opened by the UK government.

In a 'no deal' Brexit scenario the UK's Medicines and Healthcare products Regulatory Agency (MHRA) would no longer be a member of the EMA. According to the consultation paper, however, the new assessment process envisages the MHRA relying on a "positive" opinion of the CHMP.

"The targeted assessment of new applications for new chemical or new biological entities and biosimilar medicines would be based on all relevant information already submitted to the EMA and the CHMP assessment report, with a commitment to grant a licence within a timeframe of 67 days from submission of the application following the positive CHMP opinion," according to the consultation paper. "The only exception to this would be if the UK identified an objection relating to public health."

Catherine Drew, a specialist in the regulation of life sciences at Pinsent Masons, the law firm behind Out-Law.com, described the proposals as "very interesting" and said it is "clearly targeted to ensure that the UK is still seen as an attractive market for obtaining a marketing authorisation" post-Brexit.

Drew said that the timings referred to in the UK proposals reflect those that businesses can expect from the EMA's centralised procedure. She said that this means, if the timeline is met, that the UK marketing authorisation "would be granted at a very similar time to the European marketing authorisation", highlighting that the UK plans are "seeking to ensure that UK patients are not disadvantaged in having access to new products compared to European patients". 

Details of the scheme were published alongside other plans that the government has outlined to address the impact of a 'no deal' Brexit on life sciences companies. The consultation paper sets out the government's plans in a number of areas, including in relation to the post-Brexit regulation of medicines, medical devices and clinical trials.

Its paper explains, among other things, the 'no deal' implications for manufacturers' legal presence in the UK.

Legislation to underpin the proposals has been prepared in case a 'no deal' Brexit materialises.

The government has asked stakeholders for their views on the proposals, but said the "exact legal texts" are not open to change. The consultation closes on 1 November.

Dr Ian Hudson, chief executive of the MHRA, said: "Our position on medicines and medical devices regulation remains clear. We want to retain a close working partnership with the EU to make sure patients continue to have timely access to safe medicines and medical devices. However, it is important for the UK to prepare for all scenarios and this consultation is a key part of that. I therefore strongly encourage anyone that has an interest to share their comments."

"The MHRA’s vision for the future of medicines and medical devices regulations is underpinned by three clear principles, that patients should not be disadvantaged, that innovators should be able to get products to the UK market as quickly and simply as possible, and that the UK continues to play a leading role promoting public health. In the unlikely event of a no-deal scenario, the UK will strive to be at the forefront of regulatory innovation and processes. For example, looking at ways to reduce the length of time required to approve new medicines," he said.