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Media And Political Bulletin – 31 October 2018

Media and Political Bulletin

31 October 2018

Media Summary

Resolve FMD concerns at least one month before Brexit

Dispensing Doctors’ Association, Ailsa Colquhoun, 31 October 2018

The Dispensing Doctors’ Association reports that MPs have been told issues associated with the Falsified Medicines Directive should be considered approximately one month before Brexit, if dispensaries are to avoid wasted time, money and effort in implementation.

Parliamentary Coverage

EU Home Affairs Sub-Committee – Pharmaceutical industry discusses Brexit no deal preparations, Lords Select Committee Press Release, 30 October 2018

The Government has released a number of technical notices on the impact of a no deal Brexit on access to medicines and how companies should prepare. The Sub-Committee will discuss what practical steps the pharmaceutical industry is taking to prepare for the possibility of no deal, for example by stockpiling of medicines, and how effective these preparations will be.

House of Commons, Tabled and Written Questions, 29 October 2018

John Redwood (Wokingham): To ask the Secretary of State for Health and Social Care, whether all EU imported medicines approved by the NHS will remain approved on 30 March 2019 in the event that the UK leaves the EU without a deal.

Stephen Barclay: All medicines marketed in the United Kingdom are the subject of a marketing authorisation (MA) issued by either the European Commission (EC) or by the Medicines and Healthcare products Regulatory Agency (MHRA). In the event that the UK leaves the European Union without a deal, national MAs issued by the MHRA will remain valid regardless of the source of the product. MAs issued by the EC will cease to be valid but the UK is proposing that these authorisations will be converted into UK MAs in a so-called ‘grandfathering’ process that is currently part of a public consultation due to close on 1 November 2018. This would be an administrative process without reassessment of data as the MHRA has already been involved in the authorisation procedure.

Jo Stevens (Cardiff Central): To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the (a) number and (b) distribution of medicines approved as centrally authorised products which do not have a UK marketing authorisation.

Stephen Barclay: All medicines that have been approved through the European centralised procedure have a Marketing Authorisation (MA) issued by the European Commission. To date there are 1,202 products approved through that procedure. The authorisation covers all Member States and they do not need a separate United Kingdom MA. If the UK leaves the European Union, the UK is proposing that these authorisations will be converted into UK MAs in a so-called ‘grandfathering’ process that is currently the subject of a public consultation due to close on 1 November 2018. This would be an administrative process without reassessment of data as the MHRA has already been involved in the authorisation procedure.

Information on this procedure and the public consultation is available at the following links:

https://www.gov.uk/government/publications/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal

https://consultations.dh.gov.uk/mhra/mhra-no-deal-contingency-legislation-for-the-regul/consultation/subpage.2018-09-19.0744149330/consultation/intro/user_uploads/consultation-annex–3.pdf

Full Coverage

Resolve FMD concerns at least one month before Brexit

Dispensing Doctors’ Association, Ailsa Colquhoun, 31 October 2018

Issues associated with the Falsified Medicines Directive should be considered approximately one month before Brexit, if dispensaries are to avoid wasted time, money and effort in implementation, MPs have been told.

Speaking to an inquiry into the impact of a no deal Brexit on health and social care, pharmacy contract negotiators the Pharmaceutical Services Negotiating Committee (PSNC) has said: “After the UK exits the EU, access to the EU FMD hub will depend on the relationship between the UK and the EU. Access is likely to continue during the transition period, but a no-deal Brexit could undermine the time, money and effort that have been put into complying with this legislation by revoking access to this central system.”

MPs have been asked to consider the importance, cost and implementation of the FMD before Brexit.

Other concerns arising from a no-deal Brexit include the availability of generics. PSNC said: “The competitive market in generic medicines, which over the years has driven down costs for the NHS, may behave differently in a time of crisis, leading to supply issues and an increase in the cost of medicines.”

In its submission to the health select committee inquiry, PSNC asks for community pharmacies to be able to exercise appropriate professional discretion to ensure the continuity of an alternative equivalent medicine to patients, and to take measures to ensure stocks remain available for as long as appropriate, to ensure the continuity of supply to patients.

Commenting on the six-week buffer stockholding by pharmaceutical companies, PSNC warns: “[This] should go some way to ensure the supply or critical medicines to patient in the event of a no-deal Brexit, but as it is not possible to say what the conditions will be in the event of no-deal Brexit, it is difficult to comment on whether this will be sufficient.”

Media And Political Bulletin – 31 October 2018

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