Pharmaceuticals in UK. The founding partners of Edmonds Marshall McMahon have a wealth of experience in the pharmaceutical sector, having advised and prosecuted extensively for the Medicines and Healthcare products Regulatory Agency (the “MHRA”). As you may know, the MHRA is the UK’s regulator of medicines and medical devices, and EMM’s partners have a combined total of 16 years’ experience representing this agency.
By way of example, two of the founding partners successfully prosecuted the case of R v Gillespie and others (Op Singapore) (2011), the largest ever prosecution conducted by the MHRA. This case concerned the importation of counterfeit prescription only, life-saving medicines, which eventually reached the legitimate supply chain within the UK, leading to a rare Class 1 recall by the MHRA. The charges included conspiracy to defraud, Medicines Act offences and trademark offences. Much consideration was given to the ambit of legitimate parallel trading within the European Economic Area and the underlying regulatory regime.
Alongside our work with the MHRA, we have advised companies in the pharmaceutical sector on the complex licencing regime that applies to medicines and medical devices. We also have experience advising clients on all aspects of clinical trials, including the approval process and associated litigation. With all this in mind, there is little we do not know about the regulation of pharmaceuticals, medical devices and this complex legal regime. The background of our partners and senior lawyers allows us to give comprehensive, commercial and effective advice, whether we are representing government agencies or private companies.
