Director | Regulatory, Compliance & Risk
Josh Cocklin is responsible for managing due diligence investigations for clients and providing regulatory, compliance and legal advice and representation, particularly in relation to the healthcare and pharmaceutical sector. Josh has advised on a large number number of regulatory issues – including those involving the MHRA (including IAG), ICO and HMRC. He also has acted for and advised in relation to disputes with the NHS, GPhC, GMC and other healthcare regulators.
Josh has over 12 years’ regulatory, compliance and investigation experience – several years which was spent heading up the investigations/litigation support team for a global investigation/intelligence firm. Josh is a Certified Fraud Examiner and a Member of the Association of Certified Fraud Examiners. Josh is a Member of the Institute of Business Ethics, the Fraud Advisory Panel and the Chartered Institute of Legal Executives.
At present, Josh is heavily involved in providing advice in relation to regulatory and compliance matters, particularly to healthcare and pharmaceutical clients. Josh is assisting various businesses across Europe conduct due diligence investigations into their business partners, suppliers and customers.
Josh has recent and current experience as follows:
- Advising, consulting and representing various holders of an MHRA WDA(H) with referrals to the Inspection Action Group IAG for compliance deficiencies arising out of the Human Medicines Regulations 2012 and the principles of Good Distribution Practice (EU GDP) including those licence holders facing proposed (and immediate) suspension and removal of the Responsible Person and other variations by the MHRA (via IAG).
- Providing consultancy and advice to pharmaceutical wholesalers on the development of quality management systems in compliance with the Good Distribution Practice (GDP) and Human Medicines Regulations 2012, including on Quality Management Systems (QMS).
- Assisting a pharmacist the subject of an investigation by the relevant healthcare regulator – the General Pharmaceutical Council (GPHC), leading to the case being closed by the GPhC with no further action being taken at the pharmacist.
- Advising a pharmacist in connection with an enquiry by NHS England and CCG for Out of Pocket Expenses (OOPE) claims, leading to the service of a Breach Notice and the recovery of claims, successfully quashed before Primary Care Appeals.
- Assisting pharmaceutical wholesalers in connection with regulatory enquiries by the MHRA, leading to no further action being taken both in respect of the regulatory matter (arising out of EU GDP and the The Human Medicine Regulations) and the criminal enquiry (arising out of the Misuse of Drugs Act and Misuse of Drugs Regulations).
- Provided advice and representation to a wholesaler in connection with an enquiry by the MHRA relating to the dealing in high-value medicines, following a referral to the Inspection Action Group (IAG) as a result of serious deficiencies in respect of the Human Medicines Regulations 2012 and Good Distribution Practice (GDP) – including providing consultancy in respect of improvements to its operations and compliance framework, ultimately avoiding suspension of the WDA(H).
- Acting as a consultant for a pharmaceutical wholesaler to improve its Quality Management Systems (QMS) in accordance with GDP and The Human Medicines Regulations 2012 alongside the Responsible Person (RP).
- Advising a director in respect of enquiries by the NHS Counter Fraud Authority, providing general advice on process and procedure.
- Advising a WDA(H) holder (wholesaler of pharmaceutical products and medicines) in respect of exposure under the Misuse of Drugs Act, Misuse of Drugs Regulations, Human Medicines Regulations and Good Distribution Practice (GDP) in respect of deficiencies identified by MHRA subsequently referred to IAG for consideration of suspension.
- Advising and consulting in relation to a claim against the NHS in relation to its decision to refuse to pay a pharmacy for its claims.
- Providing advice and consultancy to a pharmaceutical wholesaler in respect of discrete aspects of Good Distribution Practice (GDP) and The Human Medicines Regulations 2012 arising out of aspects of its Quality Management System (QMS) as well as providing advice to the Responsible Person on preparation for an inspection.
- Assisting a pharmaceutical wholesaler in connection with regulatory compliance enquiries, leading to no further action being taken both in respect of the regulatory matter and the fitness to practice enquiry.
- Advising a regulated healthcare professional with simultaneous regulatory and fitness to practice proceedings arising out of the wholesaling of medicines, leading to no further action being taken following detailed representations.
- Advising and representing a regulated professional before their fitness to practice tribunal, leading to a dismissal of the complaint and their continuation in practice.
- Assisting a pharmaceutical wholesaler after the WDA(H) was suspended by the Inspection Action Group (IAG) following an inspection by the MHRA and a recommendation by the inspectors to suspend its licence.
- Advising a Doctor in respect of proceedings instigated by the General Medical Council before the Medical Practitioners Tribunal leading to a dismissal of the charges against the Doctor.
- Advising a pharmacist in connection with enquiries by the General Optical Council leading to a discontinuance of the fitness to practice investigation.
- Assisting a pharmaceutical wholesaler respond to an inspection report following an MHRA inspection identifying a series of deficiencies (including critical deficiencies) to the Inspection Action Group (IAG) including responding to the proposed removal of the Responsible Person (RP).
- Advising a pharmaceutical wholesaler in connection with legal and compliance obligations under the Human Medicines Regulations 2012 and EU GDP and providing advice on inter alia how to comply with requests by a regulatory agencies (including the Medicines and Healthcare products Regulatory Agency – MHRA), leading to no further action being taken.
- Providing compliance advice to a solicitor in respect of their obligations in respect of counter terrorist financing and money laundering.
- Investigated complex pan-European missing trader and VAT fraud to identify Defendants who would be subject to civil proceedings to recover funds that have been dishonestly obtained for the benefit of the client firm.Advising a regulated healthcare professional in connection with regulatory and professional enquiries relating to its dealings in high-value products across Europe, leading to a discontinued investigation after representations.
- Providing compliance and regulatory advice, and acting as a consultant to pharmacists, Responsible Persons, doctors and other healthcare professionals in respect of ongoing investigations and proceedings.
- Advising a wholesaler in relation to its obligations in respect of money laundering and counter terrorist financing, leading to a successful inspection by the supervisory authority.
- Providing advice and assistance to those seeking to apply for a WDA(H) from the Medicines and Healthcare Products Regulatory Agency – MHRA and preparing for inspections (in GDP and HMR12).
- Advised businesses on risk-based due diligence investigations for large FMCG and retailer firms across Europe on their business partners, to assist client firms in managing their risk exposure across their businesses.
Josh published a fact-sheet for the Fraud Advisory Panel titled Due diligence on UK-based third parties (December 2015). He also wrote an article for Ethical Boardroom titled Transparency in supply chains (January 2016). He is currently contributing to other due diligence, risk/governance, and ethics articles shortly due for publication.
Telephone: 0203 397 8958
E-mail: [email protected]