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Regulatory

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Regulatory Law Firm

Our regulatory practice advises the most heavily regulated industries globally, including leading pharmaceutical and biotechnology companies and major manufacturers of medical devices, veterinary medicine, chemical products, food and cosmetics.

Our team has a wide variety of backgrounds, within the fields of bioscience, neuroscience as well as a clinician specialised in veterinary medicine. Most of our lawyers have also spent some time in-house to understand the priorities faced by our clients in the day-to-day running of their business.  Combining this together with their legal and technical expertise, enhances the advice provided by our dynamic and multi-lingual lawyers on how to navigate the complex national and EU legal framework. 

Litigation

Our team has expertise in representing leading pharmaceutical companies before the national and 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.

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, orphan exclusivities, supplementary protection certificates and 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 a broad depth of expertise in conducting regulatory due diligence on behalf of acquiring companies or private equity investment companies across various industry sectors such as pharmaceutical, medical device, biotechnology, cosmetic and food. Our team is able to draw upon a deep sector knowledge to identify legal and regulatory risks as well as assessing them, whilst maintaining a commercial focus to resolve these potential issues.

Maximisation of IP rights

We advise clients on how to maximise their IP regulatory rights available to their products by analysing their products in development together with the IP regulatory rights available under the applicable regulatory legal framework (such as RDP, MP, orphan exclusivity, SPC and paediatric extensions)

Market access

We advise companies on the challenges to overcome to ensure effective market access in the UK, as well as on interactions with the relevant health technology assessment and pricing bodies (including NICE, the DoH and the NHS). We advise on the options available depending on the nature of the product (e.g. Orphan / highly specialised technologies) or the therapeutical indication (e.g. cancer treatments) since different pathways may be beneficial, and on the operation of the PPRS, the Statutory Scheme and the upcoming Health Service Medical Supplies (Costs) Bill.  

Advertising

We advise pharmaceutical (both human and veterinary medicine), 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).

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. We have a strong network of contacts within regulatory enforcement bodies which ensures that we remain ‘on the pulse’ for all regulatory trends and developments.

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. In addition, we have in-depth knowledge of the developing policy and legal requirements relating to clinical trial data disclosure. We have advised leading multi-national biopharmaceutical companies on this issue and we are frequently asked to present at industry conferences on this area.   

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.

Medical Devices

We advise on medical device status and classification (including the borderline between medical devices and consumer products), together with the requirements for the conduct of clinical investigations, the CE marking process and the quality management of devices (including device vigilance and recalls). We have particular expertise in relation to mobile apps and software medical devices.

Pharmacovigilance

Our team has a broad range of expertise in pharmacovigilance and GVP including the role of the EU QP PV, signal detection and management, support for pharmacovigilance referrals and inspections, the conduct of Post-Authorisation Safety Studies and the design and implementation of risk management plans and patient / physician support programmes, as well as the EU reporting requirements in both the pre and post marketing authorisation context.   

Bristows is a member of the Association of the British Pharmaceutical Industry (ABPI) and the Association of British Healthcare Industries (ABHI) as well as Drug Industry Association. We are also actively participating in the Legal Issues and Compliance Committee within the ABHI.

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