On 18 January the MHRA published a note 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. In the event that there are any shortages, the MHRA advises that doctors will prescribe the best alternative to a patient’s usual medication. The Department of Health has consulted on giving pharmacists power to switch prescriptions to available alternatives in the event of shortages, amid concerns to public health.
In the guidance, the MHRA refers to the fact that the government instructed healthcare 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:
- increase their medicines stocks by at least 6 weeks on top of their usual buffer stocks
- 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 costs of stockpiling are to be met by the taxpayer, but there are of course wider costs to the industry. David Meek, Chief Executive of Ipsen, was 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”.
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.
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.