A long-awaited consultation on how some elements of the EU Falsified Medicines Directive (FMD) will be implemented in the UK has been further delayed by the unexpected decision by the Prime Minister to hold a general election in June.

The Department of Health and MHRA had initially planned to start the consultation period at the beginning of 2017 but this was delayed by the need to seek further internal approvals. The consultation had been widely expected to be launched by the end of April. The pre-election “purdah” period means that this is no longer possible. The consultation is unlikely to be held until after the election, and after any Ministerial changes that might occur at the Department of Health as a result.

The consultation is expected to be accompanied by an impact assessment that sets out the potential costs and benefits of implementing FMD. The UK FMD Working Group for Community Pharmacy has facilitated visits by DH and MHRA officials to pharmacies so that they can understand the changes that are likely to be needed and the potential costs.

Whenever the consultation is published, the UK Working Group will be encouraging pharmacy contractors to respond to it.

The consultation will only cover selected elements of FMD. The majority of the EU Delegated Regulation (2016/161) that implements FMD is binding on all Member States, but there are a few areas where national governments can make changes to accommodate particular elements of their health systems.

These include the use of national reimbursement numbers, where applicable, in unique identifiers printed on packs of medicines, and Article 23, which allows wholesalers to undertake the decommissioning of medicines for certain groups or organisations that only handle small volumes of medicines as part of their activities. This does not include pharmacies or hospitals.

The MHRA has launched a Safety Features e-mail newsletter dedicated to developments in implementing the EU Falsified Medicines Directive (FMD) in the UK.

The first issue covers work that has been undertaken since the publication of the EU Delegated Regulation (2016/161) which sets 9^th February 2019 as the starting date for FMD authentication.

Those wanting to receive the newsletter can register with the MHRA by sending their name, organisation and job title (if applicable) to FMD.safetyfeatures@mhra.gov.uk. General enquiries about the implementation of safety features (unique identifiers and anti-tamper devices on medicine packs) can be directed to the same mailbox. A response is promised within five working days.

SecurMed UK has appointed Jerome Bertin as its general manager. His role will be to formally set up the UK’s National Medicine Verification Organisation and to oversee the appointment of its IT Blueprint Service Provider on behalf of the NMVO Directors and member organisations.

Mr Bertin has a background in major project management in both the pharmaceutical industry, with GSK, and in the oil and gas sector, with Shell.

SecurMed UK can be contacted at info@securmed.org.uk.

The UK’s National Medicines Verification Organisation (NMVO) has been formally established under the name SecurMed UK. The organisation brings together all the main trade bodies from across the medicines supply chain. The five sectors represented are:

• Research-based manufacturers – Association of the British Pharmaceutical Industry (ABPI)
• Generic manufacturers – British Generic Manufacturers Association (BGMA)
• Parallel distributors – British Association of European Parallel Distributors (BAEPD)
• Pharmaceutical wholesalers – Healthcare Distribution Association (HDA)
• Dispensing entities (pharmacies) – Company Chemists Association/National Pharmacy Association (CCA/NPA)

Each sector has one voting director on the board of SecurMed UK, with the pharmacy directorship being held for alternating six month periods by CCA and NPA.

SecurMed’s main purpose will be to establish and maintain a National Medicines Verification System for the UK, as required under the EU Delegated Regulation (2016/161), implementing what is commonly known as the Falsified Medicines Directive (FMD). SecurMed will do this by appointing one of three Blueprint Service Provider (BSP) companies: Aegate, Arvato or Solidsoft Reply. The BSP will develop the UK NMVS and connect all of the UK’s community and hospital pharmacies, dispensing doctors, wholesalers and others who commonly handle and dispense medicines, as well as connecting to the central European Medicines Verification System (EMVS).

The BSP appointment will be handled through a competitive tendering process and is expected to be concluded by the end of 2016, allowing the NMVS to be set up during 2017.

The UK Government has brought together organisations from across the medicines supply chain to discuss how the EU Falsified Medicines Directive (FMD) will be implemented in the UK. The meeting follows the publication of the Delegated Regulation (2016/161) that sets 9^thFebruary 2019 as the starting date for verification and authentication under FMD.

The meeting of the FMD Ministerial Implementation Advisory Board was organised by the Department of Health (DH) and the Medicines and Healthcare products Regulatory Agency (MHRA) which together form the “National Competent Authority” for medicines in the UK. The meeting was hosted by the Royal Pharmaceutical Society at its new headquarters in London.

Pharmacy representatives at the meeting included the RPS, CCA, NPA, PV, PSNC and Pharmacy Voice, as well as bodies representing pharmacists working in the hospital and prison sectors.

The board is expected to meet quarterly and a series of working groups will be established to examine particular areas around FMD implementation, including communications and the limited number of flexibilities available to Member States under the Delegated Regulation. The board will make recommendations to Health Ministers, via DH and MHRA, as to how FMD can best be implemented in the UK.