The European Medicines Agency (EMA), which approves and registers medicines and medical appliances for use and sale within the EU was originally located in London in recognition of the UK's strong position and world-wide reputation in the testing, approval, assessment and regulation of medicines. The EMA is somewhat different in structure and accountability to most other regulators. It functions as a decentralised scientific agency of the EU with its main responsibility as the protection and promotion of public and animal health within the EU, EFTA and the EEA, through the evaluation and supervision of medicines for human and veterinary use. Its operation is overseen by a management board consisting of a representative from each member state, two each from the European Commission, the Parliament and patients organisations, and one each representating doctors' and veterinarians' organisations.
However, once the Article 50 letter had been delivered by the the Conservative minority government, it was necessary to take immediate steps to protect the availability of new medicines and medical appliances within the EU. In order to ensure continuity the EMA will have to leave London before March 30th, 2019. It needs to move into temporary accommodation in the Sparkgebouw located in Sloterdijk just to the north west of Amsterdam city centre by the same date.
A permanent new home for the EMA is being constructed in the fast-developing prestigious business quarter of Zuidas to the south of Amsterdam city centre. A new station is being built to give high speed rail connections to Brussels, Paris and London and the light rail connection to Schiphol airport - only about 5 miles away - is being upgraded to facilitate intra-EU and intercontinental travel. This new head office building will be completed early in 2020.
The London-based UK Medicines and Healthcare Products Regulatory Agency - the MHRA - is an executive agency of the Department for Health and Social Care and is responsible to the Secretary of State for Health and Social Care. It has up to now carried out a quarter of all new medicines assessments for the EMA but this work cannot in future be continued by an executive agency of a non-EU government. The EMA is anticipating some capacity problems but the Dutch Medicines Evaluation Board is planning to expand to fill the gap with €2 million new investment.
However, Sander van Deventer of the Dutch biotech investor Forbion Capital Partners has been reported in January's Chemical World as seeing a possible role for companies in the UK to carry out trials in England of cell and gene therapy where efficacy and safety data can only be gathered by carrying out an actual trial. They could then approach the EMA with the data from those trials. Van Deventer sees post-Brexit England as a "hotbed for innovative medicines." He claims "innovation groups in Britain and the MHRA want to position England as a country where it is faster and easier to do complicated clinical trials with cell or gene therapy, so as to circumvent European bureaucracy."
This last point might well appeal to the Leavers who look forward to a post-Brexit UK with less regulation and fewer restrictions, but will English patients really relish the prospect of being guinea pigs to the world for the benefit of the international pharmaceutical industry? And then again it's just possible that the EMA itself might consider it unethical to use clinical data from a loosely regulated third country.
Footnote. Both the USA's Food and Drugs Administration (FDA) and UK's MHRA have been criticised in evidence to the House of Commons Health Select Committee as examples of "regulatory capture". Regulatory capture is said to occur when a regulatory agency originally set up to protect the public interest ends up serving the interests of industry and special interest groups. The EMA is obviously subject to industry pressure, but its broad based management structure provides far more safeguards against this form of corruption that the UK pattern of management by an individual minister.
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