Adrian Spooner

• Advising clients on the EU pharmaceutical legislative review including the introduction of patent early working provisions and related patent and data exclusivity controls.
• Advising on a new scheme for generic medicines supply and reimbursement.
• Advising a generic pharmaceutical company on a patent infringement dispute involving a major antidepressant medicine.
• Advising on the commercial, regulatory and intellectual property aspects on various AIM flotation’s and product acquisitions and disposals in the pharmaceutical and medical devices sector.
• Advising in judicial review proceedings to prevent the release of confidential information regulatory data relating to plant protection products.
• Advising and co-ordinating multijurisdictional UK, EU and non-EU pharmaceutical regulatory compliance and due diligence in relation to a £700 million acquisition of a major pharmaceutical company.
• Advising on UK/EU pharmaceutical regulatory and commercial matters related to the requirements for market entry of a new asthma medicine, including regulatory requirements for approval, marketing and associated infrastructure and UK pricing policy and pricing and reimbursement.
• Advising on the ownership and rights arising from biotechnology research collaboration concerned with the development of a class of oncology medicine and associated delivery system.
• Advising a major UK pharmaceutical wholesaler on compliance with generic and branded statutory price control measures and new statutory and voluntary price control measures recently introduced.
• Advising on the use of e-pharmacy and the supply of EHC and other products.
• Advising on a number of purchases of NHS retail pharmacy companies.
• Advising a UK-based medical device and pharmaceutical company on borderline issues under Directive 2001/83 and Directive 93/42 and associated UK legislation relating claims and mode of action of the relevant treatment. This work included strategic advice relating to third party rights and potential regulator action.
• Acting for a major public affairs company in relation to a report and development of pharmaceutical client based public affairs programme relating to pharmaceutical regulation, pharmacovigilance and health technology assessment and associated pharmaceutical product liability issues.
• Advising UK research tool developer on application of technology in the pharmaceutical sector and relevant IP and regulatory issues relevant to life cycle management.
• Advising on the Food Supplements Directive and UK regulation and control of food supplements in relation to potential product acquisition by client healthcare company.
• Advising on UK NHS regulations dealing with primary care pharmaceutical pricing and reimbursement and oxygen supplies and potential public law action and contractual issues.
• Advising in relation to a project to obtain a marketing authorisation for a pharmaceutical company in the EU/UK including data package protection, patent and third party rights issues.
• Advising a major company in relation to pharmaceutical supply routes, NHS, pharmaceutical professional and medicines control in the UK in relation to a major contentious health and safety matter.
• Advising on a pharmaceutical prescription only switching project in the EU including advice on procedure, classification and intellectual property protection and advice on third party supply contractual matters.
• Advising a US-based company on representations to the UK MHRA on borderline issues and labelling of a medical device.
• Advising on MBO of UK specials pharmaceutical manufacturer including manufacturing regulation and pricing issues.
• Advising on a research and development, marketing authorisation and manufacturing project in the plant protection product sector including advice on generation, ownership and use of IP rights and related regulatory issues.

Publications

• The EU Pharmaceutical Review: An essential business guide, PJB/Informa publications, 2005.

Presentations

• Primary care pharmaceutical price control in the UK: EGA Conference, London, 2005.
• Pharmaceutical Pricing and reimbursement in the EU: C5 Conference, Zurich, 2007.
• NHS Pharmaceutical Services - control of entry, the Galbraith report and the White Paper, London, 2008.
• Legal issues in fundraising exercises in the biotech sector: Genesis Biotech Seminar for British-Israeli Chamber of Commerce, London, 2008.
• Association of British Healthcare Industries Code of Business Practice Complaints Procedure and Sanctions: ABHI Code of Business Practice Seminar, Leeds, 2010.
• Biotechnology in the EU: Chilean Trade Delegations, London, 2010.