MRA Between UK and EU A Possibility Following Brexit?

The European Union has a number of Mutual Recognition Agreements (MRA’s) with third countries. These MRA’s contain principles on the conformity assessment of regulated products, the mutual recognition of GMP inspections and batch certification of products.

Essentially, an MRA is a trade agreement facilitating market access and encouraging international harmonization of GMP standards.

Such Mutual Recognition Agreements are in place with Australia (1999), Canada (2003), Israel (2013), Japan (2004), New Zealand (1999), Switzerland (2002) and the United States of America (2017).

Since the United Kingdom has formally left the EU on January 31st, 2020 it has become a third country (a country outside the European Union and the European Economic Area). In the transition period there is a temporary EU pharmaceutical law which means that MAH’s, release sites and manufacturing sites may still be located in the UK until December 31, 2020.

Brexit Consequences For Patients

After December 31 2020, all organizations will have to deal with a new status; their products are considered to be “imported medicinal products”. But this is not the only change that will impact UK-based organizations.

Withdrawal from the EU means missing out on a large pool of talented individuals currently looking elsewhere for career opportunities. Vice-versa, the EU will be missing out on British talent and resources as well. By the end of 2020 the British pharmaceutical industry will have a turnover of roughly 58 billion EUR with 650 manufacturers and an R&D investment of approximately 5 billion EUR, being rivaled only by Germany.

When we take politics and macro-economic figures out of the equation, it’s patients on both sides which incur losses in terms of availability of current medicines, the speed at which new medicines are researched or approved and higher prices on medicines due to taxation on imports.

EU – UK Mutual Recognition Agreement

To prevent some of these adverse effects; the European Federation of Pharmaceutical Industries and Associations (EFPIA) together with the Medicines for Europe and the Association of the European Self-Medication Industry (AESGP) have issued a joint statement. The statement is summarized as follows;

“In the coming months, the EU and UK should conclude an agreement that secures the greatest regulatory alignment and cooperation on human medicinal products. Reflecting precedents from previous agreements, an FTA should also include ambitious provisions on sharing of data, the protection of intellectual property (IP), customs facilitation, as well as rules of origin (RoO). We also believe the EU and UK should establish a working group on pharmaceuticals and medical devices as per the EU-South Korea Free Trade Agreement.”

As the EU and UK are both members of the Pharmaceutical Inspection Co-Operation Scheme (PIC/s) there is a great degree of harmonization already. Additionally, the British MHRA has been an integral part of the EU regulatory pharmaceutical framework for decades. With this in mind, a comprehensive Mutual Recognition Agreement is well within reach from a regulatory/technical perspective.

As the EU and UK are both members of the Pharmaceutical Inspection Co-Operation Scheme (PIC/s) there is a great degree of harmonization already. Additionally, the British MHRA has been an integral part of the EU regulatory pharmaceutical framework for decades. With this in mind, a comprehensive Mutual Recognition Agreement is well within reach from a regulatory/technical perspective.

  • The EFPIA and AESGP have provided three points detailing the benefits of a UK – EU MRA; An MRA on GMP would cover waiving batch and import testing by manufacturers and OMCLs (official medicines control laboratories) and recognition of GMP inspections between the EU and UK (covering EU and UK territories, as well as third countries).
  • This would have an immediate positive impact on the resources of the regulatory agencies, the European Medicines Agency (EMA), National Competent Authorities (NCAs) of the EU, the UK Medicines and Healthcare products Regulatory Agency (MHRA), and on the pharmaceutical sector, with benefits for patients in terms of timely access to medicines and treatments, and would help to secure the continuity of supply of medicines in both markets.
  • The resource savings for regulators should allow for the agencies to work together to focus on high-risk sites in need of inspection, including in third countries, and to ensure resources are committed to addressing such high priority needs. This would also be in line with current EU practice on MRAs, as further outlined below.

Conclusion

Because the UK and EU have both played leading roles in shaping the current GMP standards the industry believes that a high degree of cooperation will be required to allow the global supply chain to function. This is why notification of regulatory revisions is regularly included in MRA’s. The pharmaceutical industry worldwide is committed to work with any regulatory authority or commission to make the EU-UK MRA a reality in order to ensure that medicine supply is uninterrupted.