Paul Ranson is a Partner at Fasken Martineau LLP and is Head of the Life Sciences practice group. Paul is also a member of the Technology and Intellectual Property practice group.
Paul specialises entirely on the intellectual property, commercial, regulatory and product liability requirements of the pharmaceutical, biotechnology, medical device, nutritional supplement and cosmetic industries at UK, EU and international levels. Having spent the first ten years of his career as a lawyer for SmithKline Beecham and Merck (US) and holding a non-executive directorship with a substantial pharmaceutical company he has experience both within and as an advisor to the sector.
His business development practice includes both early and late-stage in and out-licensing transactions for both multinationals and biotechnology companies (including two of the largest-ever biotechnology out-licensing deals), collaborative research arrangements and product divestment and acquisitions and co-promotion and co-marketing deals for multinational and specialist pharmaceutical companies. In addition to the legal elements of such deals, as a non-executive director of a deal-led pharmaceutical company and having been involved in a wide variety of such transaction over the last 20 years he is also commonly called upon to advise clients on the strategic and commercial elements of business development.
His pharmaceutical/biotechnology regulatory practice covers the legal and ethical elements of clinical research, branding issues, data exclusivity, orphan medicines, GMP, packaging and labelling requirements, supply classification (POM to P) switches, wholesaling and distribution, pricing, pharmacovigilance, GCP audits and promotional issues (including several appearances before tribunals such as the Prescription Medicines Code of Practice Authority Appeal Board and the National Institute for Clinical Excellence).
His medical device regulatory practice extends to assisting in relation to dealings with competent authorities and notified bodies both in preparation for and after CE-marking including in particular clinical investigation, classification issues and device vigilance and risk management. In addition he has assisted clients in the cosmetic, device and nutritional supplement industries in drug/device, device/cosmetic and drug/food borderline issues.
In addition he specializes in the particular outsourcing requirements of the sector including the clinical research, development, manufacturing, sales and logistics functions and is the author of the leading legal work on the legal aspects of outsourcing by the industry.
His clients include, Alexion, Alliance, Amdipharm, Apitope, Chiesi, CM&D, Emergent, Forest, Generics, Glenmark, Kowa, Kyowa Hakko, Ipsen, Leopharma, Medesispharma, Minster, Mylan, Nordic, Nycomed, Pierre Fabre, Procter and Gamble, Schwarz, and Takeda.
Honours and Awards
- Recognised by Chambers UK as a 'Leader in their field' within 'Life Sciences: Regulatory UK-wide'; Paul is praised for the "depth of his industry knowledge and swift response rates" (2012 edition)
- Recognised by Legal 500 for his expertise in the field of 'Pharmaceuticals and Biotechnology'; clients appreciate Paul's "strong industry contacts" (2011 edition)
- Recognised by Legal Experts as an authority in the field of 'Intellectual Property' (2010 and 2011 editions)
- Recognised by Chambers UK as a 'Leader in their field' within 'Life Sciences: Regulatory UK-wide'; Paul is cited by clients as being "our first port of call for difficult questions" (2011 edition)
- Recognised by Who's Who Legal as a leader in the field of 'Life Sciences' (2010 and 2011 editions)
- Recognised by Chambers UK as a 'Leader in their field' within 'Life Sciences: Regulatory, Compliance & Competition'. Paul is praised for being "the driving light within the firm" and noted for his "extensive experience and diligence and thoughtfulness" (2010 edition)
- Recognised by Legal 500 for his expertise in the field of 'Pharmaceuticals and Biotechnology'; Paul is highlighted as being "extremely knowledgeable, patient enough to listen to a client's opinion and questions" and described as having a "nice sense of humour" whilst being "very human" (2009 edition)
- Recognised by Chambers UK as a 'Leader in their field' within 'Life Sciences: Regulatory, Compliance & Competition'. Paul is highlighted as an "enthusiastic lawyer" who "understands the regulatory issues and invariably comes up with judicious and informed solutions"; sources claim that he "should never be underestimated" (2009 edition)
- Recommended by PLC Which Lawyer? Yearbook for his expertise in the field of 'Life Sciences: regulatory'; Paul is noted for boasting "extensive research, collaboration, promotion and reimbursement expertise" (2007 - 2009 editions)
- Recognised by Legal 500 for his expertise in the field of 'Pharmaceuticals and biotechnology' and praised for being "very good" (2008 edition)
- Recognised by Chambers UK as a 'Leading Individual' within 'Life Sciences: Regulatory / Compliance'; Paul is cited as being "widely respected by peers for amassing vast sector knowledge and great industry connections". Sources comment that "he knows everything about the area and is highly experienced" (2008 edition)
Membership/Affiliations
- Legal Counsel and Steering Group Member – Ethical Medicines Industry Group (grouping of some 50 smaller/medium-sized pharmaceutical companies)
- Lay Member – Bath Local Research Ethics Committee
- Member – ABHI (medical devices trade association) Legal Issues Committee