Working with colleagues in the US or separately on discrete EU matters, the members of our London team provide complementary advice on all aspects of EU regulatory law and procedures for companies in the pharmaceuticals (human and veterinary), biotechnology, homeopathic, herbal, and medical device sectors.
We have significant experience in advising the suppliers of both prescription-only and over-the-counter products and have developed special experience in the field of novel technology products such as gene-based, cell-based, and tissue-engineered products. We also have substantial experience in relation to borderline products and mainstream cosmetic, food supplement, and biocide products.
We provide contentious and non-contentious advice side-by-side and have represented clients in many administrative law proceedings against regulatory agencies before both UK national courts and the European Court of Justice.
Our London team includes a significant number of lawyers who are also qualified in medicine, toxicology, pharmacy, or other scientific disciplines and has strong links with local and community trade associations, regulators, and members of the scientific community. The group also has a network of preferred specialists in other jurisdictions within and outside the EU with whom it collaborates when matters raise both local law issues as well as overarching aspects of EU law.
Regulatory. In the pharmaceutical and biotech field, we provide advice on the full gamut of regulatory matters from pre-clinical/GLP, through clinical research/GCP and compassionate use/named-patient supply issues, to manufacturing/GMP and wholesale dealing/GDP questions. We advise on all types of post-marketing obligations, including advertising, patient information, classification of medicines, pharmacovigilance, data privacy, and product lifecycle management. We have substantial experience in defending companies in the context of enforcement actions taken by either self-regulatory bodies or the competent national authorities.
We have helped clients in relation to every aspect of the process required to gain marketing authorizations in Member States (whether through the national, decentralized or mutual recognition procedures) or from the EMEA/European Commission through the centralized approval route. We have extensive experience in relation to the particular issues raised by orphan drugs, pediatric research, conditional authorizations, and authorizations based upon “exceptional circumstances,” and have steered many clients through appeal procedures at the national and community level.
We have acted for many innovator companies on issues concerning generics or biosimilars and have represented clients in a high proportion of the proceedings concerning regulatory data protection rights that have arisen both at the national level and in the many references to the European Court that have resulted from such national proceedings.
We provide counsel regarding the regulatory regime for medical devices, including active implantables and in vitro diagnostics. This includes issues relating to CE marking, vigilance, and recall. We have considerable experience in classification issues on the borderline between medicinal products and medical devices and in relation to drug/device or biological/device combinations.
Pricing and Reimbursement. We advise clients on pricing and reimbursement issues and have a very substantial practice advising clients on technology assessments, whether conducted by the National Institute for Health and Clinical Excellence, the Scottish Medicines Consortium, or the All Wales Medicines Strategy Group. We have represented many clients successfully in appeals against provisional determinations.
Product Liability. We have significant experience advising on non-contentious and contentious product liability relevant to the pharmaceutical, medical device, and related medical product sectors. We have conducted the defense of claims relating to marketed products and products still under research. We have represented clients in a high percentage of the major multiclaimant group actions that have been pursued in the United Kingdom in the last 25 years and have coordinated product liability proceedings across the EU. Many of these proceedings have involved jurisdictional questions, particularly forum shopping by claimants between the EU and US. We have also worked on two of the largest worldwide schemes of compensation established through US court procedures.
Other Matters. Working with specialists within the firm on patents, trademarks and copyright, or in competition law, our European regulatory lawyers assist in providing thorough and timely advice on issues that require a cross-section of skill sets, such as on the rules governing parallel imports, parallel distribution, or counterfeits, and in the drafting of clinical trial, distribution, co-marketing, co-promotion, or other collaborative agreements. We frequently advise upon the regulatory aspects of due diligence in corporate and commercial transactions.