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The Minister of State, Department of Health (Paul Burstow)
I congratulate my hon. Friend the Member for Stourbridge (Margot James) on securing the debate and on setting out so clearly the issues that affect many of our constituents. Ensuring that NHS patients have access to the medicines they need when they need them is absolutely vital. My hon. Friend is right to have described the situation in such terms herself. I can assure her that the Department takes the supply issues she has raised very seriously indeed.
It might be helpful if I start by giving a sense of the scale that we are talking about. There are about 16,000 licensed presentations of medicines. That covers different formulations such as tablets, capsules and injections, and different dosages. The most recent figures record that there were more than 10,600 community pharmacies in England and nearly 900 million prescription items are dispensed each year. The production of medicines is truly a global business, with ingredients supplied from all over the world. In such a large and complex system, there will from time to time be problems with the supply of medicines. However, where there is evidence of systemic or real issues, the Government need to act and intervene appropriately.
Such problems are not new, and nor are they confined to the UK. They can occur for a number of reasons; for example, there might be manufacturing problems or difficulties in obtaining raw materials. They can also occur as a result of distribution problems, or through the parallel exporting of medicines when exchange rates or prices make that a lucrative trade. The increasing trend towards the concentration of manufacture within global pharmaceutical companies has exacerbated the situation. That means there is little flexibility if problems are experienced at particular manufacturing sites. Production schedules have to be planned months in advance, and if one company is unable to supply a product, others may be unable to make up the shortfall at short notice. Therefore, there is a need for the regulatory framework that my hon. Friend talked about.
Supply issues can also arise as a result of the parallel trade. The strong euro means that parallel imports into the UK have declined and the incentives for UK medicines to be exported to other European countries have increased. I stress that, as my hon. Friend said, parallel exporting is legal and that it can be carried out legally by anyone who holds the necessary licences under the medicines legislation. She has rehearsed some of the statistics on the number of companies that have such licences, and as has rightly been said, prevention of the export of UK medicines would be contrary to EU trade laws.
However, there are legal duties on marketing authorisation holders and manufacturers and distributors within the limits of their responsibilities to ensure appropriate and continued supplies to pharmacies, so that the needs of patients are met. The Government work closely with pharmaceutical companies, wholesalers, pharmacists and the NHS to ensure that the system delivers medicines to patients quickly. They also monitor individual supply problems and work closely with individual manufacturers to prevent shortages, and manage consequences when there are shortages.
As has been said, the Department has published joint best practice guidelines with the Association of the British Pharmaceutical Industry and the British Generic Manufacturers Association in order to help manage shortages as and when they arise. Those give guidance to companies on what to do in the event of a shortage, and recommend that companies communicate with the Department as soon as possible about impending shortages that are likely to impact on patient care. The Department, the Medicines and Healthcare Products Regulatory Agency and pharmaceutical supply chain stakeholders—the manufacturers, wholesalers and pharmacy representatives—continue to work collaboratively, better to understand and mitigate the impact of supply difficulties associated with parallel exports, so that patients receive the medicines they need.
We have also established, as was said, the medicine Supply Chain Group as a forum for organisations to meet and exchange information, understand the causes of the supply problems, including those due to parallel trade, and seek possible solutions. The Supply Chain Group continues to meet with individual companies in order better to understand the issues, and to explore ways of mitigating them and to take forward the action points agreed at the ministerial summit last year.
My hon. Friend asked about lay and patient representation on that body. As I understand it, the British Medical Association plays a part in acting as a conduit for that voice. There is a good case for looking at whether that should be changed, so that such representation is not simply through the BMA and that patients have their own voice in those deliberations—not least given the Government’s commitment to the introduction of Health Watch England and the desire to see a greater place for patient interests across the system.
The summit made a number of recommendations. The first, as we have discussed, was the publication of “Best practice for ensuring the efficient supply and distribution of medicines to patients” in February 2011. That also offers practical guidance on the use of quotas by manufacturers. Also published was the joint guidance on the legal and ethical obligations on the supply chain, “Trading Medicines for Human Use: Shortages and Supply Chain Obligations”, in November 2009. That was updated and republished in December 2010. We also developed and are maintaining a list of products in short supply. That is published on the Pharmaceutical Services Negotiating Committee’s website, so that no one—I repeat: no one—trading in those products has the excuse that they are not aware of supply difficulties. The MHRA is conducting a series of targeted inspections aimed at those who jeopardise patients, in order to ensure that they comply with their supply duties and that those who breach existing duties face the consequences.
My hon. Friend said that there have been no prosecutions. The intention is to change behaviour and ensure compliance, rather than undertake regulatory intervention, which would result ultimately in suspending licences or in criminal proceedings, although in many other cases licences are suspended for other reasons. As a result of those arrangements, medicines are getting through to patients. I am concerned, however, to hear the examples given by my hon. Friend today. As she documented, there are in some cases completely unacceptable periods of delay. However, the latest evidence from the pharmacies at the end of the supply chain is that in England there are supply problems with approximately 50 products.
My hon. Friend raised a point about standards and the work being done by the MHRA to ensure that packages are consulted on to improve quality standards across the system. The approach to inspection is a risk-based one involving targeted inspections, and there has been an increase in the number of staff to support the resulting increased work load. I stress that the 50 products currently identified as being in short supply have to be seen in the context of the 16,000 licensed presentations of medicines. The affected medicines are used to treat a wide range of conditions. They include treatments such as Femara for breast cancer, Cipralex for depression and CoApprovel for hypertension. For that reason, the guidance we issued in February recommends that pharmacy and general practice staff should advise patients to request their prescriptions in good time. Most companies have put contingency arrangements in place, so that pharmacies can obtain supplies of medicines directly from them if they are unable to obtain them from their usual wholesaler. The time taken for supplies to be obtained in that way varies from company to company, depending on the nature of the arrangements, but we have been assured by the companies concerned that they endeavour to supply their products as soon as possible. However, I will draw the attention of officials and others to the evidence that my hon. Friend has drawn my attention to today.
I would like to take this opportunity to pay tribute to the efforts made by pharmacy staff, who have worked tirelessly to ensure that patients have not gone without their medicines—it is key to stress that. Patients and prescribers also have an important part to play. Prescribers should, where appropriate, consider a change in medication for patients, and advise patients to request prescriptions in good time where there are supply difficulties.
My hon. Friend referred to article 81 of directive 2001/83 as a textbook example of the UK Government’s not gold-plating such a regulation, but said that in this case, that was possibly not the thing to do. I hope that I have outlined a series of measures that this Government are taking to secure the supply chain and to ensure that everyone in the supply chain understands their obligations to patients. I stress, however, that we have not ruled out taking any of the further steps she has suggested. We want to be sure that we have proper evidence of resulting harm to the patient interest before we act. That is why we are keeping matters under review, and targeted inspections will play their part in gathering further evidence. If there is other evidence from other parts of the supply chain, we would certainly want to look at that carefully. The London School of Economics is doing some comparative work, looking at other jurisdictions where such public service obligations have been introduced, and that will also inform our thinking.
I am grateful to my hon. Friend for raising these important matters. I assure her that the Government are committed to patients getting their medicines quickly. If all parties in the supply chain adopted the best practice guidance issued in February, the problems caused to patients by parallel trade would reduce. The guidance sets out the aim that, under normal circumstances, pharmacies should receive medicines within 24 hours, although there may be circumstances where that is not always the case. We do not believe that increasing the regulatory burden at this point is the right answer, but we will keep that under review. The Government will continue to work closely with all those involved in the supply chain to ensure that NHS patients get the medicines they need when they need them. That is our enduring commitment.