UK Calls for Mutual Recognition of GMP Certificates in Brexit Negotiations

The United Kingdom government has detailed what it hopes to get out of its Brexit trade deal talks with the European Union. UK officials are seeking multiple provisions intended to facilitate trade in medicinal products, for example by proposing for each side to recognize good manufacturing practice (GMP) certificates issued by the other.

Unlike the European Commission, which provided scant details of its thinking about medicines and medical devices in its negotiating guidelines, the UK government detailed multiple specific objectives related to the industry in a document outlining its approach to the talks. The UK government wants an annex on medicinal products designed to facilitate cross-border trade and “support high levels of patient safety.”

Specific goals include the aforementioned mutual recognition of GMP certificates. The UK also wants to agree to mutual recognition of batch testing certificates, citing the Comprehensive Economic and Trade Agreement between the EU and Canada as a suitable framework for that part of the deal.

Other parts of the document also look to existing relationships between the EU and other countries for inspiration. If the EU agrees, the reuse of elements of existing agreements could cut the time it takes to strike a deal, thereby helping the UK to hit the tight deadline for completing negotiations.

The other areas in which the UK wants the EU to copy existing agreements include the sharing of confidential information. Agreements between the European Medicines Agency (EMA) and its counterparts in Canada, Switzerland and the United States are in line with the type of arrangement the UK wants to reach with the EU. The UK also wants to cooperate on pharmacovigilance.

UK officials focused their goals for the annex specifically on medicinal products. However, they are open to expanding its scope to “cover procedures relating to vaccines and other biological medicinal products, and clinical trials” in order to “further promote public health.”

The UK outlined its plans for the EU negotiations shortly before publishing a document about planned free trade talks with the US. Reflecting public concerns about the US deal, most of the references to the biopharma industry in that document seek to provide reassurance that the agreement will not affect the price of, or access to, medicines in the UK. The document also reveals that continued alignment with the EU emerged from a survey as the top priority for the biopharma industry.

With the UK government keen to free the country from the constraints it faced as part of the EU, it is unclear if the biopharma industry will get its wish. The government continues to talk up the benefits of leaving the EU, including in a recent debate about the Medicines and Medical Devices Bill that is making its way through parliament.

“This bill empowers us to be able to move faster. Essentially, it empowers the UK to build a life sciences regulatory framework that is the best in the world … all with the intention of getting the most innovative products, as quickly as possible and as cost-effectively as possible, into the NHS. That is the goal of the entire Bill. It is a benefit of Brexit,” Matt Hancock, the secretary of state for health and social care, said during a debate about the bill.

Source: RAPS