LIFE SCIENCES LAW
We advise on legal issues relating to the Pharmaceuticals, Biotechnology and Biopharmaceuticals industries, Clinical Research Organisations and the specialist wholesale distribution of medicines.
Our Specialisms Include:
- Intellectual Property licensing of pharmaceuticals, including in-licences from, and out-licences to, third parties.
- Distribution agreements for pharmaceutical products in the UK, EU and globally.
- Terms and conditions of purchase and sale of medical products and items used for manufacturing and research purposes.
- Clinical Trial Agreements between pharmaceutical companies and Clinical Research Organisations.
- ABPI Code of Practice for the promotion of medicines; making claims against, and defending claims from, other pharmaceutical companies alleging breach of the ABPI Code which is administered by the Prescription Medicines Code of Practice Authority.
- Data privacy and GDPR including the anonymisation/pseudonymisation of patient personal data in clinical trials, the holding of personal data on medical practitioners and also the transfer of personal data outside the UK/EEA, and to the US in particular, following the Clarifying Lawful Overseas Act 2018 (CLOUD Act) and the foreign Intelligence Surveillance Act (FISA) in the US, the Schrems II case in the ECJ, the EU’s Standard Contractual Clauses, the ICO’s UK addendum to the SCCs, the EU-US Data Privacy Framework and the UK extension to this framework known as the Data Bridge.
- Contract-manufacturing agreements and templates
- Regulatory matters involving the Medicines & Healthcare products Regulatory Agency (MHRA) in respect of medicines and medical devices.
- Research and collaboration agreements with third parties, including universities and other research organisations.
