The plans for minimising the risks and dangers of medicines and medical supplies during a no-deal Brexit are accelerating and being given increased press attention.

The MHRA published a note on 18 January aimed at the UK public, on getting medication in the event of no-deal.

  • In the guidance, the MHRA notes that around 75% of the medicines and over 50% of the medical devices and one-use medical products (such as syringes) that the NHS uses, come into the UK via the EU.
  • The MHRA states that the government has analysed the supply chain, and given instructions to pharmaceutical companies (and medical devices companies) to ensure they have adequate stocks to cope with any potential delays at the border.
  • On 23 August 2018, Matt Hancock, Minister of Health, wrote to pharma companies to request suppliers to (i) increase their medicines stocks by at least 6 weeks on top of their usual buffer stocks; and (ii) ensure plans are in place to air freight products with a short shelf life that cannot be stockpiled.
  • On 23 October 2018, the Minister wrote to medical devices companies to request suppliers that source products from other EU countries to review their supply chains and determine what measures they need to take (i.e. including stockpiling) so that they can continue to provide products in the event of a no deal exit.

The actual costs of stockpiling medicines and devices are to be met by the taxpayer, but there are of course wider costs to the industry.  David Meek, Chief Executive of Ipsen, is reported in the Financial Times as saying that Ipsen was spending in the tens of millions of Euros on Brexit preparations, the equivalent of the cost of a phase-one trial.  The same report included details of Eisai’s early planning resulting in a six month stockpile of its cancer and epilepsy products, with its factory production running an extra four hours a day, and every weekend.   Eisai alone has transferred licences for about 60 medicines to Germany — at a cost of about €7,200 each simply to change the name of the licence holder from “Eisai Europe in Hatfield” to “Eisai GmbH in Frankfurt”.

  • Politico has reported that AstraZeneca has increased the number of finished medicines available to pharmacies and hospitals in the UK and EU by 20% to minimise the risk of shortages in a no-deal situation, spending £40 million in no-deal preparation, including building laboratories in Sweden to duplicate product testing functions.  Relatively little detail is publicly available across the industry on this, however; the Department of Health & Social Care confirmed in December it had entered into 16 non-disclosure agreements with companies, and 10 with trade associations, to restrict what can be said publicly about no-deal plans and the costs being incurred.

The Department of Health has consulted on plans to give pharmacists powers to switch prescriptions to available alternatives in the event of shortages, amid concerns to public health. Following the consultation, the government has now laid before parliament draft legislation to give pharmacists the authority to substitute treatments from a prescription when the prescribed medicines are in short supply, the “Serious Shortage Protocol”.  The legislation is due to come into force early next month. Although the speed with which the government has responded has been welcomed by key stakeholders such as the Pharmaceutical Services Negotiating Committee, which represents the interests of community pharmacists, key concerns about the practicalities involved remain.

Dr Keith Ridge, the Chief Pharmaceutical Officer, wrote to pharmacists on 17 January, giving additional guidance on how the Serious Shortage Protocols would be developed, saying that it would be done so with input from clinicians, and could cover dispensing a different quantity, pharmaceutical form, strength or a generic or therapeutic equivalent.  Dr Ridge also warns pharmacists that it is “not helpful or appropriate” to stockpile medicines themselves, as this can risk additional pressure on supplies for patients in other parts of the country.

The Independent reports that around 10,000 passengers who had booked with Brittany Ferries between 29 March and mid-May have had their bookings cancelled and rebooked onto different departures.  Passengers affected by this were informed by the Roscoff-based company that their original sailing had been cancelled due to “the government’s initiatives to create additional ferry capacity for the transportation of critical goods (such as medicines) across the Channel”.  Britanny Ferries (France’s largest employer of sea-farers), the Danish ferry firm DFDS and a start-up company, Seaborne Freight (which proposes a Ramsgate-Ostend link, but has no ships at present) were the three companies awarded the Department for Transport contract outside the normal tendering process, allowed “for reasons of extreme urgency brought about by events unforeseeable”.

Author

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

Author

Els Janssens is a senior associate in our Abu Dhabi office and provides knowledge management support to Baker & McKenzie’s global and MENA Pharmaceutical and Healthcare industry group. Els started her career in 2000 at Baker and McKenzie in Brussels focusing her practice on pharmaceutical law and commercial litigation. She has worked six years in London as a legal adviser with the European Medicines Agency (EMA). During this period she has supported the EMA’s activities in medicines oversight and regulation and interacted with the European Commission on legal matters relating to medicinal products. She also worked one year as senior legal counsel in Johnson & Johnson’s European legal department providing regulatory advice regarding various medicinal products and supporting the public affairs function on new legislation.

Write A Comment