Neumans LLP acted for Mr Hitendra Patel who has recently successfully appealed his conviction in the Court of Appeal. Counsel for our client were Mr Orlando Pownall QC and Martin Howe QC. Counsel for the Prosecution were Sandip Patel, Fiona Jackson and Jemima Stratford (instructed by the Solicitor for the Department of Health).
There are a number of reasons why the case is of significant public importance and also of wide importance to the pharmaceutical industry. This includes but is not limited to the following:-
1. For the first time, the Medicines for Human Use (Marketing Authorisations) Regulations 1994 (“the Regulations”) will not be construed as prohibiting transactions which were not intended for the release of a medical product into a distribution scheme which would lead to its sale to end users within the European community. Effectively, selling such medicinal products to a wholesaler within England but for use outside of the EU is permissible. The impact to the industry is enormous.
2. In this case our client, a licensed pharmaceutical wholesaler, imported (unknowingly) counterfeit Viagra into the UK and sold it to another wholesale dealer for onward sale to a company in the Bahamas.
3. The products were packed in the same manner as Viagra is sold in the United States. Such a manner is not authorised in the European Economic Area.
4. The key issue that was determined was whether the words “places a relevant medical product on the market” in paragraph 1 of Schedule 3 to the Regulations applied to the facts of this particular case where the goods were intended for the Bahamas and not for the EU.
5. The Prosecution’s submission was that the touchstone of liability under the Regulations was control, with our client no longer having control over the product’s ultimate destination once he had sold them to the other wholesale dealer in the UK, thereby being released into the distribution chain in the UK. This submission concentrated on the public health aspect of the legislation at the expense of its other objective, the efficient functioning of the internal market in pharmaceutical products.
6.The Court of Appeal held that the Regulations were not to be construed as prohibiting transactions which were not intended to have the effect of releasing such products into the EU.
7. The case is of such significance that the Department of Health have dropped a prosecution against another client that we act for who was charged with similar offences. Please click here to see the Court of Appeal Judgment which has already been reported in the Weekly Law Reports.
8. The case is not only of significant importance to the public at large but also the pharmaceutical industry in particular.
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