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.
- 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…