Our regulatory practice, lead by Maria Isabel Manley, serves the most heavily regulated industries globally, including leading pharmaceutical and biotechnology companies and major manufacturers of medical devices, chemical products, food and cosmetics.
Our team has a wide variety of backgrounds, including in the fields of bioscience, neuroscience and reproductive medicine in the clinical setting. Combining this legal and technical expertise, our dynamic and multi-lingual lawyers navigate the complex national and EU legal framework in order to advise on all regulatory aspects of life cycle management and commercialisation of blockbuster products.
Life cycle management: We advise leading international companies on the full range of strategic issues arising during the life cycle of a pharmaceutical product, from its development to its commercialisation. This encompasses advising on anything from the marketing authorisation of a product (including chemical, biotech and orphan products) to the legal implications of parallel trade (such as stock management policies). In this context, we focus on defending IP regulatory protection mechanisms (e.g. regulatory data protection, supplementary protection certificates and under the paediatric regime). We are supported by certain leading technology law firms in Europe and the US with whom Bristows has an established relationship. This network enables our team to deliver a seamless service in the co-ordination of multi-jurisdictional litigation and legal advice.
Regulatory due diligence: Our team has developed extensive experience in conducting regulatory due diligence exercises in the context of the acquisition of pharmaceutical, biotechnology and food companies.
Litigation: Our team has expertise in representing leading pharmaceutical companies before the national and the European Courts as well as before the regulatory authorities, including the European Commission, the European and UK medicines authorities (EMA and MHRA), the National Institute for Health and Clinical Excellence (NICE), and the Department of Health. We also represent clients before the Food Standards Authority (FSA) and the European Ombudsman. For example, we represented Novartis AG in the Swiss/Liechtenstein case before the Court of Justice of the European Union; and we are now representing AstraZeneca AB on SPC issues before the English Court. Further, we represented Servier Laboratories Ltd on an appeal before the UK’s NICE Appeal Panel and subsequently before the English courts for Judicial Review (with a successful outcome before the Court of Appeal). Currently, we are representing a pharma company before the General Court regarding the Commission’s refusal to grant a Marketing Authorisation for an orphan drug. We are also representing a leading pharma company under investigation by the EU Competition Commission as well as representing them in an action in the UK Courts. Our team is also experienced in co-ordinating EU and overseas litigation.
Interpretation of EU and UK regulatory framework: We advise clients from various sectors on the interpretation and application of legislation relevant to their business. This includes advising on the regulatory framework applicable to borderline products, medicinal products, medical devices, cosmetics and food.
Labelling: Our team has experience in advising on the EU and UK labelling requirements applicable to pharmaceuticals and medical devices as well as to general consumer products, including cosmetics, food and drinks.
Clinical trials: Our team has expertise in advising pharmaceutical, biotechnological and medical devices companies in relation to the negotiation of clinical trial agreements and the interpretation of the applicable legislation.
Product liability:Our team has expertise in advising on the interpretation and scope of the product liability directive and provides regular advice to pharmaceutical and medical devices companies in relation to product liability issues arising out of the conduct of clinical trials, including negotiating settlement agreements. Our lawyers also advise on issues in relation to the recall of defective products from the market either on the initiative of the client or at the request of the regulatory authorities. We have also recently advised in the context of an inquest by the Coroner involving a product of one of our clients.
Advertising: We advise pharmaceutical, medical devices and cosmetics companies on the national and EU legislative framework, the applicable codes of practice and guidelines and potential defamation claims arising out of promotional and trade material. Our team also assists major pharmaceutical companies in the preparation of submissions and represents them before the Prescription Medicines Code of Practice Authority (PMCPA).
Bristows is a member of the Association of the British Pharmaceutical Industry(ABPI) and the Association of British Healthcare Industries (ABHI). We are also actively participating in the Legal Issues and Compliance Committee within the ABHI.