UK life sciences bodies submit concerns over ‘no deal’ Brexit
Associations representing the pharmaceutical and biotechnology fields have said that the UK should maintain “close cooperation” with the EU post-Brexit, to ensure that access to safe and effective medicines continues in both markets.
The Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) announced that they filed a joint submission on a ‘no deal’ scenario, in response to a consultation announcement, on November 1.
The consultation period, which closed that day, was announced last month by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and the UK Department of Health & Social Care (DHSC).
They sought industry views on how the MHRA’s legislation and regulatory processes would need to be modified in the event that the UK government and the EU are unable to reach a deal before the UK’s exit from the union on March 29, 2019.
In their response, the ABPI and the BIA said that industry believes a ‘no deal’ Brexit would “significantly” damage public health, as well as the UK life sciences sector.
“This must be avoided at all costs,” the associations said.
Mike Thompson, CEO of the ABPI, said that a ‘no deal’ Brexit would seriously impact pharmaceutical companies’ ability to get medicines to patients.
According to the ABPI and the BIA, “close cooperation with the EU in the regulation of medicines, including mutual recognition of regulatory activities and quality testing, is essential in ensuring that patients in the EU and the UK can continue to access safe and effective medicines”.
Thompson said it is “absolutely right” that the MHRA is putting plans in place, but the “consultation brings home the reality of 40 years of close cooperation breaking apart”.
“It’s clear that the combined protection they have delivered to public health, the control of infectious diseases and managing the safety of medicines for patients will be compromised without ongoing, close cooperation,” he added.
Another post-Brexit concern of the associations is the lack of incentives linked to the research and development of orphan medicines.
Steve Bates, CEO of the BIA, explained that there are no measures in the MHRA’s and DHSC’s consultation that would replace existing EU incentives for biotech companies, making the UK less attractive than the EU for companies wanting to launch orphan drugs.
“A ‘no deal’ Brexit would lead to double red tape for life sciences companies wanting to operate in the UK and the EU,” he warned.
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