As the All-Party Pharmacy Group (APPG) continues its inquiry into the issue of shortages in NHS prescription medicines, I wanted to explain ABPI’s position on these issues; describe the steps we are taking to address it, and outline how we can achieve a long term solution to this challenge.

 

A shortage in NHS prescription medicines is a relatively new phenomenon. It has arisen because the UK now has among the lowest priced medicines in Europe due to fluctuations in exchange rates. Essentially some medicines intended for use in the UK are being (legally) traded and sold abroad for a profit by a small number of retail pharmacies, estimated by IMS Health at 11%. This puts UK patients at risk of not being able to get the treatments they need. While manufacturing problems can happen on occasion, they are rare and there are well-established mechanisms for protecting supply to patients.

Manufacturers can experience sudden and very large changes in demand for a medicine, due to the diversion of UK supply for exports. One manufacturer we are aware of has faced demand equivalent to 26 years’ UK supply for one of its products in a period of just five months. Manufacturers and wholesalers have a legal duty to ensure continuity of supply of medicines and to help ensure this there is an oversupply to the UK market between 115% and 130% on average.

But when others in the supply chain divert supply meant for UK patients, it is essential for manufacturers to manage their stocks accordingly. This is done through the use of legitimate measures, such as quotas, to ensure that additional orders are due to genuine UK patient demand, therefore preserving stock that is needed for UK patients.

We understand the frustration that quotas and other measures can sometimes cause individual pharmacies, but they are essential to manage stocks of medicines that are in short supply to ensure they are available for UK patients. Manufacturers have put in place emergency supply routes and significant extra resources to help ensure medicines that are in short supply reach patients, and some retail pharmacies are increasingly finding ways around the measures. Nevertheless, a longer term solution is needed that sustainably addresses supply shortages.

Firstly, we are calling for the legal separation of pharmacy wholesaling and dispensing activities, so that pharmacies which serve NHS patients directly prioritise the UK patient over and above wholesaling activities which effectively divert supply of medicines. Increased transparency will allow suppliers to prioritise dispensing to UK patients when they supply a product that is in short supply. This already occurs in some other EU member states and is recommended as best practice by the UK regulator, the MHRA.

Secondly, we believe that in the longer-term the level of regulatory oversight and inspection of the trade in medicines needs to be looked at. Relatively unregulated wholesaling activity brings an increased risk of counterfeit medicines entering the supply chain. There are approximately 1,800 Wholesaler Dealer Licences in the UK, which allow licensed pharmacies to export medicines. This is the highest number in Europe, with the exception of Germany, by a significant margin and the Medical and Healthcare products Regulatory Agency (MHRA) in the UK lacks sufficient resources to inspect all of these premises.

Ultimately, we recognise that the only way to achieve a long-term solution to the problem of medicines shortages is through collaboration. As a result we have provided both oral and written evidence to the All-Party Pharmacy Group (APPG) inquiry highlighting the benefits a legal separation of pharmacy wholesaling and dispensing activities would achieve.

We have also been involved in the Department of Health's Supply Chain Forum, which has been very active in discussions to resolve this problem. Additionally, we have recently set up a Pharmaceutical Advisory Group (PAG), to input to the Supply Chain Forum by seeking consensus on solutions that can then be put to the Forum. All parts of the supply chain have been involved in the PAG and discussions continue.

Stephen Whitehead
ABPI Chief Executive

 
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