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 has been reported in January’s as seeing a possible role for companies in the UK to carry out trials
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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