Brexit

这周的阅读内容是英国脱欧对医药行业的具体影响,我比较关注的是欧洲药物管理局EMA和英国药物管理机构MHRA即将面临的变化,以及他们将对医药公司带来的影响。

The article made a comprehensive review on Brexit of possible implications for pharmaceutical regulations. Although it was written 2 year ago right after the referendum, the predictions remain significantly challenging to MHRA and the industry. The only decision made seems to be the EMA relocation to Amsterdam. But that's much easier than clearing up the relationship and between agencies and possibly re-establish a collaborative and effective regulating system under Brexit.

There are two potential models predicted. One is following the model like Norway, Iceland and Liechtenstein, as a member of EEA. This would allow UK to retain the access to the EU's single market, but step outside of EU. An MHRA update in early 2018 stated that "the existing EU legislative framework" will be converted into UK law to avoid sudden changes; and "minimum disruption and burden on companies" will be ensured as a result of Brexit.1 From the industry perspective, becoming a EEA member also allow MHRA to remain as a member of EMA, which would benefit the industry most.

However, the EEA framework has a major impact in various areas. Staying in the EEA, which ties UK back to EU, would definitely compromise the initial expectations of Brexit. If UK would take the challenge and choose another regulation model like Switzerland, massive changes are to expected in healthcare industry despite of the current MHRA promises. Major impacts on clinical trials, marketing authorizations and data exclusivity would be the first priority concerns for the industry. The new agency will face various challenges including funding, human resources, and external collaboration.

Although the transition period of MHRA-EMA framework has not been announced, EMA has announced a take-over plan of review work in centralized procedure products, as the Brexit planned in March 2019.2 MHRA has been fading out from certain EMA collaborations as a effect of Brexit, but it may take years for the country to confidently establish its independent pharmaceutical regulatory system, after so many years in the EMA framework. That would be a great challenge to all parties, especially to the applicant companies.

References:

MHRA. (2018, January 16). MHRA update to pharmaceutical companies on exit preparations. Retrieved April 19, 2018, from https://www.gov.uk/government/news/mhra-update-to-pharmaceutical-companies-on-exit-preparations
Moore, A. (2018, April 16). MHRA will lose EMA work before Brexit transition period. Retrieved April 19, 2018, from https://www.pharmaceutical-journal.com/news-and-analysis/news/mhra-will-lose-ema-work-before-brexit-transition-period/20204675.article

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