The UK is scheduled to leave the European Union on 31 October 2019. However, there is great uncertainty and inconsistency of opinion as to whether the departure will be again postponed if an extension is granted, or the UK will be leaving the EU without a deal in place. To cover all bases the UK Government has, as part of its previous no-deal preparations for its now postponed March 2019 departure date, introduced new legislation to cope in a situation where there is a possibility of a drugs shortage in the UK market (which, at present is a real possibility that is trying to be mitigated). Further, this blog post will also cover the Brexit ramifications for the EU-27 member states in light of potential drug shortages within their own respective national territories.

1. UK Developments

The UK Government has recently introduced what are known as Serious Shortage Protocols (SSPs) under the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, which amend the Human Medicines Regulations 2012. As a result, UK pharmacists have now been given unprecedented powers to substitute drugs they are unable to get hold of, for other drugs which may not necessarily have the same active ingredients as those prescribed.  This development clearly has potentially wide-ranging ramifications whereby a pharmacist dispensing drugs within the UK can override a doctor’s prescription if “the UK … is experiencing or may experience a serious shortage of medicinal products … arising from the withdrawal of the UK from the EU”, provided a specific SSP has been issued as a direct result of a particular medical product shortage. Although a “serious shortage” has not been defined by the legislation, it seems apparent that it would occur when there is a significant possibility of a shortage of drugs within the UK market, even though all other preventative measures have been taken and have been exhausted with no success at preventing such a shortage.

When Would an SSP Be Issued?

As the name suggests, an SSP would only be issued when there is a serious shortage of a particular medicinal product within the UK, which would threaten patient welfare. However, it is important to note that SSPs will not be issued as and when, and that they will only be issued when it is deemed absolutely necessary to do so, and the Department of Health alongside the pharmaceutical industry are unable to source the relevant medical product elsewhere to meet demand in the UK market. Further, in a recent briefing paper published by the Pharmaceutical Services Negotiating Committee (PSNC), the PSNC noted that in relation to SSPs:

·        an SSP would only be issued if, in the Secretary of State for Health and Social Care’s opinion, there is, or may be, a serious shortageof a medicine or appliance then he or she may consult, for instance with medical experts, and decide to issue an SSP;

·        any SSP issued must specify an alternative product or quantity that may be supplied (an alternative strength or formulation, or generic or therapeutic alternative or less of the product) by community pharmacies;

·        community pharmacy contractors must consider the SSP and, if, in the supervising pharmacist’s opinion– exercising his or her professional skill and judgment – the alternative product or quantity is reasonable and appropriate for the patient, they may supply the alternative product or quantity (only as specified in the SSP and subject to any conditions in the SSP), provided that the patient consents/agreesto the alternative SSP supply; and

·        changes to certain medicines, even where they are in short supply, will not be suitable for some patient groups – for example those with epilepsy, where changing a patient’s medicine brand or generic manufacturer could cause harm to the patient. SSPs will only specify changes to specific medicines that medical experts believe to be appropriate, and pharmacists will always have the professional discretion not to supply an alternative to any individual patient.

One issue that is apparent, however, is that if there is a situation where a certain patient does not consent to the alternative SSP supply, and this is coupled with a serious shortage of the specific drug in the market that the SSP has been issued for, then there is a clear risk to a patient’s health and welfare, particularly if such a patient has a medical condition that makes being prescribed the alternative SSP supply not feasible.

2. EU Developments

Within the EU, the European Medicines Agency (EMA) has recently published guidance that focusses specifically on the detection and notification of medicine shortages whilst providing a clear, concise definition of what a “shortage” is. The guidance that has been published has clear ramifications for Brexit, as it gives national regulators insight into what to do if there is ever a situation of drug shortages within their respective territory. The key points to take away from the guidance are as follows:

·        the definition of a “shortage”. It has been defined as follows:  “a shortage of a medicinal product for human or veterinary use occurs when supply does not meet demand at a national level”;

·        the EMA noted that the lack of a common definition meant that identifying a shortage of a product early on was difficult and, naturally, inconsistent in nature with differing levels of success amongst the EU member states;

·        based on the above definition and irrespective of the clinical importance of a medicine, the following issues should be reported (i) all shortages which are currently affecting one or more EU member states; and (ii) all impending/anticipated shortages which are expected to affect one or more EU member states.  Further, the EMA noted that this includes not only current but also future shortages which may occur and are not limited to specific problems such as regulatory issues etc.;

·        the responsibility for monitoring the supply and reporting of shortages rests not only with the MAHs but also with their distributors, and that there is an obligation on the MAH to notify the relevant competent regulatory authority when a product is being removed from a specific EU market and that such notification should be made no later than two months before the product is being removed from the relevant market.

The EMA has also published additional guidance that focusses on how regulators should communicate such shortages to the public, which also includes health care professionals, and what is considered “best practice” in doing so. Some important considerations to bear in mind are as follows:

·        the public should be given timely, accurate and up to date information about such shortages to ensure that care is not impacted in any way, or to the extent it is, that it is mitigated as much as possible;

·        the guidance also contains key principles and examples of what is considered good practice, and should therefore be a first port of call for national regulators when considering any announcement that is to be made; and

·        the EMA and applicable national regulators should, in accordance with good practice, use systematic listing when communicating specific information about shortages to the public to ensure consistency and clarity in the same.

The developments in both the UK and EU sphere are a welcome step to providing clarity within the pharmaceutical sector, as to the potential implications of Brexit and how the same are being mitigated through appropriate consultations with the relevant industry bodies/authorities. However, it is clear that there is still much more to do, and until the present Brexit chaos within the UK is under control, it is difficult to see whether the preparations being undertaken by the pharmaceutical industry (both within the UK and EU) will be sufficient to overcome any disruption to supply. We will continue to monitor the situation.

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.

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