28/29 September 2022
Already in the first quarter of this year, three European industry associations (EFPIA, Medicines for Europe and AESGP) published a "Call for a Mutual Recognition Agreement on Good Manufacturing Practice (GMP) in the Context of Ambitious and Comprehensive EU-UK Future Relationship Negotiations". In this paper, the associations state that the EU and the United Kingdom (UK) should have the closest possible relationship, particularly in the field of pharmaceuticals. They call for a free trade agreement to be reached as soon as possible followed by a Mutual Recognition Agreement (MRA).
Other pharmaceutical associations have now joined in and a letter was sent directly to Commission President Ursula von der Leyen, the Presidents of the Council and Parliament, as well as to Commissioner for Trade Phil Hogan and to Michel Barnier, Head of Task Force for Relations with the UK. In addition to EFPIA, Medicines for Europe and AESGP, EUCOPE (European Confederation of Pharmaceutical Entrepreneurs), EuropaBio and Vaccines Europe support this "Joint Letter on the Need for a Mutual Recognition Agreement between the EU and UK".
In this letter, the authors are "extremely concerned about the lack of progress in the negotiations" and ask to "to prioritize health and patients' access to medicines" in the negotiations and "shield them from larger political considerations". It is feared that a failure of the negotiations will lead to disruptions in the supply chains for medicines, which will result in delays in access to medicines for patients in both the EU and the UK. In the long term, the competitiveness of the EU and UK vis-à-vis the US, Japan and China will be affected.
An MRA could also be agreed on outside the official trade negotiations, with the aim of mutual recognition of batch and import testing, Official Medicines Control Laboratories (OMCLs), GMP inspections and CE-marking of medical devices. Reference is made here to already existing, comparable agreements with other countries.