NHS Prescribed Medicines

Wednesday 4th May 2011 Westminster Hall

11:00

[Margot James (Stourbridge) (Con)]

It is a pleasure to serve under your chairmanship, Mr Meale. I am grateful for the opportunity to open this debate on the crucial matter of securing the supply of medicines in the interests of the patients for whom they are prescribed.

Ever since the pound gained against the euro a few years ago, the UK has experienced shortages of medicines, because some stakeholders find it more profitable to sell medicines intended for use by patients in the UK abroad, where higher prices, aided by the exchange rate, will prevail. Ministers are making efforts to resolve the problem, and I will return to the action that is being taken when I discuss some of the potential solutions.

First, I want to focus on the nature and scale of the problem and its effects on patients and pharmacists. It used to be the case that, if someone was prescribed a medicine by a GP, they went to their local pharmacy, handed over the prescription, waited for a few minutes and then went home with the pills. Occasionally the pharmacist would apologise, because they did not have the item in stock, and the patient would return the next day to collect their medicine.

Some years ago, I was responsible for the various medicines prescribed to my elderly parents. I was annoyed to find that, sometimes, the medicine that I collected from the pharmacy was Greek or Spanish, with inadequate English language directions. The pharmacist had dispensed a parallel imported drug, on which extra profit had been made by the wholesaler and, possibly, the pharmacist. Back in 2005, parallel imported medicines accounted for 18% of the value of branded medicines dispensed by UK pharmacies.

The tables have now been turned and our continental partners are being prescribed medicines intended for the British market that have been subject to parallel export. This has led to patients in Britain being prescribed a medicine, taking the prescription to their local pharmacy and being told that the product is not in stock and that it might be a few days before it will be. Patients are advised that they can shop around but, if it is a particular type of drug that is routinely demanded at a higher price on the continent, the chances are that neighbouring pharmacies are experiencing the same problem in accessing supply.

The effect of that shortage can range from minor inconvenience to potentially serious health risks. The BBC programme “You and Yours” featured the problem at the beginning of April. It interviewed an organ transplant patient who needed continuous treatment with the drug Rapamune to ensure that their body did not reject the new organ. The very idea that such a drug should be hard to obtain is absolutely scandalous, which is also true of that person’s experience.

How widespread is the problem? Chemist and Druggist, the pharmacy trade publication, conducted a survey of pharmacists last September that highlighted the difficulties caused to pharmacists, 90% of whom are not profiting from the shortages caused by selling medicines abroad. The survey found that pharmacists have had to turn patients away, because they had not been able to source the medicine prescribed. Moreover, 93% of pharmacists had at some stage had to ask the doctor to change a prescription in order to secure the supply of something similar. More than two thirds of pharmacists are spending between one and five hours a week chasing around, trying to get hold of out-of-stock medicines. That is a complete waste of pharmacy time and, now that the Department of Health has agreed to pay for that time, it is also a waste of NHS money.

Research conducted at the end of last year by the Devon local pharmaceutical committee supports the findings of the Chemist and Druggist survey and provides additional insights. Seventy pharmacists monitored medicine supply issues for a two-week period and identified 537 such issues, which was up from the 379 issues reported in a similar study by the same group a year previously. The problem has, therefore, been getting worse.

The Devon audit found that the average delay caused by one of those instances to the medicine being available was four and a half days, which is pretty much a whole working week. It was found that those delays caused minimal harm in 13% of cases, but in just over 5% of cases the harm was defined as moderate. For example, a missed dose of an anti-epilepsy medicine caused a patient to fit. In nearly 20% of those cases, the pharmacist had ultimately to go directly to the manufacturer to order the medicine via the emergency procurement procedures.

I have mentioned that the principal cause of the problem is the export of medicines intended for UK patients to other European markets. I should point out that it is not possible to prevent the export of UK medicines per se, because that would be contrary to the free movement of goods guaranteed by European trade laws. We might, therefore, expect the same problems to be experienced by other countries when the exchange rate boot is on the other foot. There is no doubt that, during the years when extra profit was obtained by importing medicines into the UK, there were similar shortages of medicines in some countries, such as Greece and Spain. There was, however, no such shortage in other markets such as Germany, so we cannot lay the blame for this problem on the liberal trading laws of the EU, which are something that I think we all support.

The cause of our problem goes beyond the trade in medicines across national boundaries. The law governing the supply of medicines derives, in part, from article 81 of European Union directive 2001/83. The directive simply requires the maintenance of appropriate and continued supply of medicinal products by marketing authorisation holders and distributors. It was introduced into UK law via statutory instruments in 2005. At that time, the UK Government did what I would applaud in all normal commercial situations. They incorporated the directive into UK law with minimal—well, zero—gold-plating. It was, in fact, a textbook example of how we would want our Government to deal with European regulations under normal commercial circumstances. Medicines, however, are different from other products, especially medicines that treat serious conditions such as cancer, Parkinson’s disease, which is another area in which there have been significant supply problems, and organ transplant patients. Sometimes, medicines can make the difference between life and death, which is why the research, manufacture and promotion of medical products are such highly regulated activities. That is not true, however, of distribution. The reason for the difference between the UK and continental markets, such as Germany, Belgium and France, is that those and other markets that signed up to the EU directive incorporated their own more stringent conditions in respect of securing a continuous supply of medicines.

Before I conclude by giving the Minister some recommendations on action to resolve the problem, I want to acknowledge the efforts that the Minister and his team have made thus far to improve the safety and supply of medicines to the public. Efforts have also been made by manufacturers, wholesalers and pharmacists. The Department of Health hosts a supply chain forum, which has recently published best practice guidance and will meet again in a few weeks’ time. I welcome the steps being taken by the forum to address the problem. Participants represent all stakeholders in the complex system of medicine supply. However, I want to ask the Minister whether patients are represented, because I have not seen any reference to patient organisations in the notes that I have seen from the meetings thus far.

All stakeholders involved in the group have committed to the principle of enabling a minimum standard of 24 hours to supply any prescribed medicine to a pharmacy, and manufacturers and wholesalers will risk prosecution if they breach the code of ethics in relation to that supply standard. The Government have promised to raise the standards for wholesaler dealers’ licences, which I very much welcome.

I wish all those actions well, but I am concerned on two fronts: first, that those actions do not go far enough and, secondly, that the MHRA, which is charged with policing the system, is not adequately resourced to monitor and enforce the recommendations. Given the financial incentives to sell certain products abroad and the number of traders with wholesale licences in the UK, my concern is that the difficulties of policing all the organisations, combined with the lack of prosecutions to date—I think that there have been nil prosecutions—for breaching existing duties to supply medicines do not bode well and make me think we need to strengthen those existing duties.

I want to express my appreciation to the British Association of Pharmaceutical Wholesalers and the Association of the British Pharmaceutical Industry for the help they have given to me during my research for the debate. The ABPI and the BAPW have called on the Government to strengthen the existing duty of wholesalers, and indeed all stakeholders, to supply medicines within 24 hours in the way other European markets have done. The introduction of what has become known as a patient service obligation, which obliges wholesalers to guarantee permanently an adequate range of medicines, is required to enable patients to receive an NHS prescribed medicine in the necessary time scale and to allow pharmacists and dispensing doctors to receive a medicine following its order and dispense it within 24 hours of a patient presenting the prescription.

Manufacturers and wholesalers should be obliged to hold buffer supplies, as those who operate to a high standard currently do, to help pharmacists to manage spikes in demand. That is really no different from obliging banks to hold capital reserves. Banks have recently been required to hold a higher proportion of capital on reserve, and I am calling for the same principle to be applied to the essential supply of medicines. Public health is as important as the supply of money, so why should similar precautions not be applied?

Finally, the patient service obligation needs to be backed up by the more stringent regulation of wholesalers. Germany and other countries place much stricter obligations on wholesalers than those that are required in this country. They are required to have appropriate facilities to hold a full range of products and a reserve supply of those products. Indeed, I am not sure why we need so many wholesalers in the UK. Another aspect to the problem the MHRA has in policing the system is that we have 1,800 licensed wholesalers. That number leapt up mysteriously over the past two years in response, I suspect, to the exchange rate. There are just 39 wholesalers in France, 90 in Belgium and six in Denmark. Across the EU, only Germany has more wholesalers than the UK.

I trust that I have given the Minister food for thought, and I urge the Government to consider more rigorous regulation in this essential area of the provision of medicines to the general public. I hope that the Minister will share with us some of his forward thinking about how the steps he has taken so far will be policed, monitored and might pan out over the coming months.

11:15

[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.

11:26

[Margot James]

Thank you, Mr Meale, for your chairmanship. I thank the Minister for his generous and comprehensive response. I remain concerned that the measures do not yet go far enough, but I am reassured that measures have been put in place and that the 60 or so medicines affected will be monitored closely. I hope that I am wrong and that it will not be necessary to introduce more stringent regulations, because I am a great campaigner against increasing the regulatory burden on industry. Patient safety, however, has to be paramount. I am not yet convinced that the measures will have the desired effect, but I am willing to keep an open mind, monitor the situation and bring any further evidence of problems to the Minister.

11:27

Sitting suspended.