EMA Excludes MHRA from Regulating EU Drugs from March 2019 - What Will MHRA Do Next?
The European Medicines Agency has announced that it is reallocating all the regulation of EU medicines currently done by the UK's regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), from Brexit on 30 March 2019.
The MHRA currently plays a bigger role than any other national agency, carrying out approximately 30% of assessment, vigilance and licensing.
In her key Brexit Mansion House speech at the beginning of March, Theresa May had called for continued close co-operation and ties between the EMA and MHRA through associate membership of the EU medicines regulator. She saw this as a two-way benefit, given that not only can the UK benefit from close ties but also the MHRA has a lot of expertise on which the EMA currently relies.
The Department of Health had believed that the Brexit transitional period, which is expected to last until the end of 2020, would see little change in this working relationship. However, the EU is clearly planning for a 'hard Brexit' from March 2019, and will not allow the MHRA to have any role in the EMA during that period. The MHRA will not be able to engage in centralised regulatory procedures as co-rapporteurs. Instead, there may be a possibility of working together after the transitional arrangement, as part of a longer term deal.
The EMA is currently looking for "a robust allocation of the workload across the European medicines regulatory network", so that the drug regulation work currently undertaken by the MHRA will be done by other EU Member States or Norway and Iceland.
The Association of the British Pharmaceutical Industry (ABPI), the body representing 'big pharma' in the UK, has voiced disappointment with EMA's position, saying it would disadvantage both sides. Mike Thompson, the ABPI Chief Executive, commented: "It is clearly in the EMA's interest to continue to draw on [the MHRA's] expertise. It would also be disadvantageous for the EU to be unaligned with the UK as the largest biopharmaceutical cluster outside of the US. The UK Government has been clear that cooperation on medicines is a priority and we urge both sides to come to an early agreement in the interest of patients and public health."
The future of medicine regulation after Brexit has been a major issue for the pharma industry, due to the centralised medicine approvals and clinical trial regulations. The concern is that future differences in regulation could slow down product approvals and see more limited access to medicines, with the UK falling down the pecking order of priorities as a market to supply drugs due to added regulatory hurdles.
Comment
The EMA's position is disappointing, but may be part of a wider position of posturing in the Brexit negotiations.
At the PING annual seminar on 5 June, we will be hearing from Dr Ian Hudson, the Chief Executive of the MHRA, on issues such as this and where he sees the MHRA's future.