Motion made, and Question proposed, That this House do now adjourn.—(Greg Hands.)
May I thank you, Madam Deputy Speaker, and your good offices for granting this Adjournment debate on a subject that affects hundreds if not thousands of people right across the country in England, Wales, Scotland and Northern Ireland? I hope to encourage, support, prompt, cajole and beat the Minister—in a very nice way—to put some urgency into this matter, which I know he is aware of and is working on. I think that we need to do more. I can understand why this issue has not grabbed the headlines that other health-related issues have.
A very wise MP once said to me, “Don’t go looking for issues. They will walk though your door.” That is exactly what happened. A female constituent came through my door about a year ago and said, unbelievably—it was unbelievable and I had some scepticism about it—that she could not get Femara, a cancer treatment drug. I said that that simply could not be the case because it is a readily available drug. It is not a drug that is not prescribed or that there is any shortage of. She left feeling a little disgruntled, but I agreed to take up the issue.
I contacted the chemist, who said that my constituent was absolutely right. They said, “I cannot get hold of it in my own stocks, I cannot get hold of it locally by ringing other chemists and I cannot get hold of it from my regular distributors. I actually have to ring the manufacturer.” Even having done that, there was a delay before it was delivered, leaving somebody without their cancer treatment drugs. The implications of that are not only physical and medical, but emotional.
Having looked into the matter further, it appears that this is a widespread concern. Like most people, I assumed that if a drug was a prescribed medication, it would be widely and freely available. I did not know about the systemic problem that we face in the UK in ensuring the supply of life-saving medicines. If one looks behind the façade of normality, one can see clearly the pressure on the pharmaceutical drug supply chain from manufacturers, through wholesalers and distributors, to pharmacists and right down to individual patients.
The Minister will be aware that today there are problems with about 50 products. Those medicines treat a wide range of conditions including cancer, Parkinson’s disease, schizophrenia, depression, asthma, diabetes and high blood pressure. All of those products seem to be in short supply due to the problem in the supply chain. In the midst of coming to terms with a serious medical condition, the last thing that I, the Minister, you, Madam Deputy Speaker, or anybody would want to face is the fear of not being able to receive their treatment or of having it interrupted because of a problem in obtaining the medicine. Yet that is the precise situation for too many people on a daily basis.
It is our community pharmacists on the front line who see the overwhelming reality of this problem. I know that the Minister will recognise that when pharmacists cannot get hold of a drug for their patients, they work hard behind the scenes, under the calm waters, often in a Herculean effort, to ensure that nobody is left without their vital medicine. I have seen in my constituency the hoops that pharmacists are obliged to jump through to obtain medicines on such occasions. All too often, they have to ring round other pharmacists in the hope that they have the medicines available, spend time on the phone to the wholesaler or the manufacturer, or send faxes with copies of prescriptions to manufacturers in the desperate effort to find supplies on the day for their patients. On too many occasions, they are told that there is no stock available from the wholesaler or the manufacturer. Despite the time spent on that wild goose chase, pharmacists still try to provide the multitude of other services that the NHS and we ask of them.
I congratulate the hon. Gentleman on securing this debate on such an important topic. Is he aware of the survey conducted as recently as this month by Lloyds Pharmacy of its pharmacists, which confirmed the point that he is making? It found that 50% of the pharmacists surveyed were spending between one and three hours a week trying to source medicines, and that 16% were spending between four and six hours a week doing so—almost a day of their working time.
Absolutely. The hon. Lady makes a very good point. I am aware of that survey, and I will touch on it. This is not a party political issue at all, it is very much cross-party, and I know she has a real interest in and specialist knowledge of the matter. We can help the Minister by suggesting to him some ways forward.
The Lloyds survey to which the hon. Lady refers was of 400 pharmacists, and it showed that 80% of pharmacists were unable to dispense items, or had had to call their local GP surgery, for four or more prescriptions a week. For 26%, that number rose to more than 10 prescriptions a week. On average, half of pharmacists surveyed were spending at least one to three hours a week trying to resolve stock availability problems for patients. That includes ringing around other stores, contacting suppliers and liaising with prescribers. Critically, as she said, 16% spend at least four to six hours a week doing so, and 8% spend more than six hours a week chasing down stock.
Another survey that has been undertaken, of which the House may not be aware, is a 2011 preliminary survey on medicine supply shortages by Chemist and Druggist online. It found, echoing those earlier findings, that 93% of respondents were spending more than one hour a week sourcing key medicines. It found that 54% were spending more than two hours a week doing so, and that 10% were spending five hours or more. If they are doing that, they are not providing the front-of-counter services that we want them to, such as helping people with minor ailments and providing other assistance. That survey also found that 90% had had to ask GPs to change a prescription in the face of shortages, and that 70% had found getting hold of branded medicines even harder in the past year than in previous years. Those figures mirror those in the previous survey the year before. The problem is at least as bad as it was a year ago, and possibly getting worse.
Let me personalise the matter. I spoke to a community pharmacist from Rasharkin in Northern Ireland this week, who told me:
“Supply chain issues are becoming an increasing problem as I continually have to telephone the manufacturer directly for stock. For example today”—
Monday 21 November—
“we had four prescriptions outstanding for a drug for depression; we had ordered these electronically through the manufacturer’s chosen supplier five days ago but the stock has still not arrived. We had to telephone the manufacturer for stock today and they insisted we supply copies of the prescriptions. I refused as I believe there are issues here with patient confidentiality. They agreed to send only a partial order. Two of the above patients will be without their medication until the supply arrives, the other two have enough to keep them going for a few days.”
Patients in that situation are all too often left with only a small supply, and sometimes with none of the medicines that they need. Research by the Patients Association found that half of those surveyed had had to wait two or more days to get their medication when there were stock availability problems, and that two thirds felt from their personal experiences that medicine shortages were definitely having an impact on people’s health. That situation will see real harm caused.
The Chemist and Druggist 2011 survey has already found tangible incidents of harm caused to patients by a lack of available medicines. To cite some examples, it found incidents of a pharmacist having to refer a patient back to hospital because of a shortage of drug supply; patients describing themselves as “stressed and upset”, and suffering severe emotional trauma; a patient experiencing difficulties with anxiety that had previously been controlled by their medication; and a diabetic patient suffering a hyperglycaemic episode while waiting for their medication.
The evidence showing the problems in the supply of medicines to local pharmacists is clearly overwhelming. The reality for patients, including the one who came through my door a year ago, is frightening. Despite the hard work of pharmacists everywhere, the results could be fatal. We must avoid that. The situation was noted by the all-party group on pharmacy this week when it announced that it will hold a full-scale inquiry into the continuing problem of shortages in NHS medicines.
The reasons for the shortage in the supply of such crucial medicines, as in any situation, are varied. First, as the Minister will know, European competition policy promotes a free market in medicines. The trade is legal and encouraged by the EU. With the weak pound, there is money to be made—by pharmacists, wholesalers and others—by selling drugs to those in Europe.
The Association of the British Pharmaceutical Industry states that the recent Medicines and Healthcare products Regulatory Agency announcement that it will repeal section (10)(7) of the Medicines Act 1968 to prevent pharmacists from trading without a wholesale licence is an important step in the right direction, but it will not solve the problem. Experience has shown that supply in the market well beyond what is needed for UK patients does not solve the problem of shortages at pharmacy level —it simply results in more stock being diverted overseas.
The second reason is the number of wholesalers. There are now 1,800 wholesale dealer licences in the UK. Additionally, according to the British Association of Pharmaceutical Wholesalers, six years ago, a pharmacist could order from their chosen wholesaler almost any medicine manufactured, but nowadays, they need to order from at least two or three wholesalers, which means two or three deliveries at different times of the day, with two or three times the paperwork.
Thirdly, quotas put in place by manufacturers to control demand are crude and lack the flexibility to meet ordinary fluctuations in demand. In one case, a pharmacy was restricted by a quota to 28 days of supply for a medicine, meaning that it was unable to fulfil 56-day prescriptions. To overcome such situations, pharmacists must place so-called emergency orders directly with the manufacturers for stock to be delivered individually in unscheduled deliveries, which often arrive via courier companies one or two days after the identified patient need.
Increasingly, patients are forced to wait while the pharmacists make daily emergency orders with various manufacturers. They often have to go through quite intrusive audit questions to prove they have a genuine patient need. On top of that, the patient has to await delivery. Another pharmacist—from Gwynedd—said of this unacceptable situation:
“In many instances after phoning our wholesalers and the manufacturers and even…specialist wholesalers, we are eventually able to source the drug, but it doesn’t arrive for 2 to 3 days.”
In March 2010, the then Secretary of State, my right hon. Friend the Member for Leigh (Andy Burnham), held a summit meeting of all industry stakeholders and formulated an action plan. In February 2011, the Department of Health published guidance, but as we approach 2012, a solution is still not in sight, unless the Minister brings some clarity today. The guidance is a step in the right direction, as recognised by Pharmacy Voice, but it is not the silver bullet—there is no silver bullet. Problems remain and it is time for further affective action to be taken.
What should that action be? We should update the regulations on patient access to medicines to make them fit for purpose. Currently, there is a duty to supply, but no time scale in which to do so within the UK. Other EU nations, including Belgium, France, Finland, Germany, Greece, Hungary, Italy, Norway, Portugal and Spain, have implemented a patient or public service obligation—I prefer the phrase “patient service obligation—on the manufacturers and wholesalers to ensure that community pharmacists can get medicines to their patients when and where they are needed. It is time for the UK to implement its own, albeit adapted, version of a patient service obligation. The Minister might be hesitant to do that, but we place obligations on distribution network operators to connect people to the national grid to ensure that they receive an uninterrupted supply of electricity, and yet we have no obligations on an uninterrupted supply of medicines.
There are different ideas on what would constitute a patient service obligation, but let me suggest some principles that might underpin one. First, all those who supply medicines, whether manufacturers, distributors or dispensers, should have a duty to ensure that the medicine supply chain is economically efficient in line with the clinical needs of patients, so it delivers to them on time. Secondly, all those who supply medicines should have a duty to ensure that patients can easily and quickly obtain the medicines they need and to prioritise the supply of medicines to UK patients. Thirdly, medicine supply arrangements must be sufficiently robust and stable to guarantee a continuous supply to patients, including the rigour needed to absorb any short-term disruption—for example, through extreme weather conditions, as we saw last year.
Such a patient service obligation would receive support across the supply chain from manufacturers, wholesalers, pharmacists and patients. The National Pharmacy Association and the British Association of Pharmaceutical Wholesalers are already on board, and the Association of the British Pharmaceutical Industry is keen to learn more. Indeed, the Government have not ruled out a patient service obligation. I see no reason why active discussions between all interested parties—the manufacturers, wholesalers, pharmacies and patients associations —cannot begin immediately, brokered by the Minister and the Department of Health. Perhaps the Minister would like to know that a recent Pharmacy Voice survey has shown that such a move would find considerable favour with the public.
It is time for the Department of Health to lead on this vital issue. The evidence is overwhelming and the urgency palpable. Everyone is ready to find a solution and ensure that the aims of a patient service obligation—ensuring that no one goes without their vital medicines—are more than just an ambition, and become a reality. I hope the Minister in his response—I know that he is aware of the critical nature of this issue—can assure the House of his intention to act on this issue with real urgency.
May I begin by congratulating the hon. Member for Ogmore (Huw Irranca-Davies) on securing this debate? I know that he has been assiduous in highlighting this important issue in his constituency and beyond, and anyone who doubts that need only have listened to his speech—or read it in Hansard tomorrow—to know about his commitment to, knowledge of and passion for this issue of genuine concern in many areas. It is also a pleasure to see my hon. Friend the Member for Stourbridge (Margot James) in her place, as I know that she has a long-standing interest in the subject, having secured a debate on the pharmaceutical situation earlier in this Session.
I assure all hon. Members that I am sadly all too aware of the difficulties that pharmacists and members of the public have had in obtaining some prescription medicines. It was particularly moving when the hon. Gentleman spoke of the experience of someone he knows who regrettably had trouble getting hold of one of her medicines, Femara, which is used to treat breast cancer. We freely discuss policy at meetings and in the Chamber, but those discussions suddenly seem very distant when we are confronted with the reality of what it means to be unable to access a drug. I am aware that some pharmacists have had difficulties getting Femara, but those difficulties have recently been greatly reduced following the expiry of the patent earlier this year. The generic version of Femara is now widely available under the name letrozole. I know that it is of little consolation to the hon. Gentleman’s friend, but what it does mean is that other people will not have to go through the same heartache as that lady.
I am also aware of how frustrating it is when such problems occur with other drugs—not simply cancer drugs—because for people who need them at the time, they are equally important. The coalition Government have already taken action and we will take further action if necessary.
Supplying medicines to patients requires a complex, international infrastructure. There are around 16,000 licensed medicines covering tablets, capsules and injections, and different dosages, and nearly 900 million NHS prescription items are dispensed every single year. As hon. Members will appreciate, it is a vast undertaking. Given that complexity and scale, there are difficulties from time to time, and not only the UK is affected: recently the US has had problems of its own. There are many different reasons why patients might have problems getting hold of their medicines, and they range from difficulties in obtaining raw materials to manufacturing problems and the overseas sale of medicines intended for this country. I would like to speak about all of these.
Supply issues can arise as a result of parallel trade, as the hon. Gentleman mentioned. That is when medicines are bought at low prices in one European country and then resold at higher prices in another. When the euro got stronger relative to the pound, exporting UK medicines to other European countries become more profitable. At the moment, parallel trade exports are therefore reducing the supply of medicine available to UK patients. I stress that this parallel exporting is legal and can be carried out by anyone who holds the necessary licences under the medicines legislation. Indeed, in the past, UK patients have benefited from medicines being imported to this country by the same process.
I cannot stress firmly enough that there are existing legal duties on manufacturers and distributors, within the limits of their responsibilities, to maintain a suitable supply of medicines to pharmacies so that the needs of patients are met, but regrettably a minority of operators in the supply chain are thought to be putting profit before patients. I know that this is not condoned by the majority of those in the supply chain. Indeed, manufacturers and pharmacies have to fill the gap that these practices create.
Manufacturers have introduced quotas to try to target supply but this reduces pharmacies’ flexibility to meet unexpected patient need. Pharmacies use contingency arrangements to get medicines directly from the manufacturer rather than from their usual wholesaler. We have recognised this in NHS funding for community pharmacies but it still annoys the majority that are putting patients first. I understand that that is frustrating for many parts of the supply chain and can lead to delays in some patients getting their medicines. However, the Department of Health, the Medicines and Healthcare products Regulatory Agency and the supply chain stakeholders—manufacturers, wholesalers and pharmacies —are working together to reduce the impact on patients.
In order to address the issues with supply, the previous Government set up a ministerial summit in March 2010. A wide range of organisations and individuals participated, including those representing pharmacists, wholesalers and doctors. The summit agreed a package of tough actions to be taken forward in collaboration with the industry and other partners. This Government have taken forward many of the actions proposed by the previous Government. We continue to work with all parts of the supply chain to make sure it functions as well as possible through collaboration and collective agreement rather than by increasing the regulatory burden.
Actions taken forward following the summit include: publishing updated guidance on the legal and ethical obligations placed on manufacturers, wholesalers, registered pharmacies and others involved in the supply and trading of medicines in December 2010; publishing best practice guidance agreed by stakeholders of the supply chain clearly stating that under normal circumstances pharmacies should receive requested medicines within 24 hours—if all members of the supply chain followed this, patients might get medicines more quickly—and developing and maintaining a list of products in short supply published on the Pharmaceutical Services Negotiating Committee’s website so that no one trading in these products can say that they are not aware of supply difficulties.
On top of that, MHRA site inspections and follow-up inspections have been conducted and progress has been made, including through written undertakings to comply with the agency’s recommendations. To date, no breaches of the regulation have been established.
This is not a new phenomenon. As the Minister said, the previous Government recognised it, set up the taskforce and introduced proposals on which this Government are acting. The difficulty is that the system is not working properly, despite the best will in the world. I understand the one-in, one-out rule and the necessity to avoid an undue regulatory burden, but a light-touch approach would be welcomed by most of the industry. A manufacturer told me the other day that he was producing 140% of the needs of the UK but there was still a shortage of the drug that he was supplying. Surely a patient service obligation would fit the bill by ensuring that certain things have to happen. It has been done in most other European countries.
I am grateful to the hon. Gentleman, and I will come to that point a little later in my remarks.
As I was saying, exporting medicines is only one source of supply difficulties. Problems such as obtaining raw materials or problems with manufacturing processes can also cause supply problems. The increasing concentration of pharmaceutical manufacturing has made the situation worse. A medicine may be made only in one or two sites globally, which means that there is not much flexibility if problems are experienced at a particular factory or manufacturing site. Production schedules have to be planned months in advance and if one company has a shortfall, suppliers of alternatives may be unable to make up the shortfall at short notice.
The current trend in the supply chain of pharmaceuticals over the past few years is to move towards a “just in time” set-up, which results in lower stocks of medicines throughout all parts of the supply chain. This trend has resulted in significant savings, but requires more active and reactive stock management. Again, the Government work closely with pharmaceutical companies, wholesalers, pharmacists and the NHS and have well-established procedures to manage these risks.
The Department of Health published joint best practice guidelines with the Association of the British Pharmaceutical Industry and the British Generic Manufacturers Association in January 2007. The guidance gives companies advice on what to do in the event of a shortage and recommends early communication with the Department about possible shortages that might affect patient care. This allows us to work together to explore whether any action can be taken to reduce the impact on patients.
The Department has also created a small buffer stock of some medicines to help manage shortages during pandemics and other emergencies. We are also taking action through the European Commission’s falsified medicines directive to strengthen the supply chain against the risk of counterfeit medicines. This aims to improve the reliability of the medicines supply chain and to respond to the increasing threat of falsified medicines entering it.
As a direct result of the arrangements I have described, combined with the diligence and professionalism of most of the supply chain, patients overwhelmingly have access to the right medicines in a timely and efficient manner. We are continuing to monitor the situation very closely. Of course, we are not prepared to be complacent. That is why we are working so closely and collaboratively with the supply chain, monitoring and intervening as appropriate.
The hon. Gentleman’s intervention was about the public service obligation. I am aware that some—like him, and quite honourably—would prefer to see a public service obligation placed on the medicines supply chain to maintain supplies of medicines. As I have said, it is already the case that manufacturers and distributors must ensure continuous supplies of medicines to meet patients’ needs. Failure to do so could put them at risk of regulatory action or criminal prosecution.
Some other EU member states have a very precise definition of how soon medicines should be received, but we are cautious about going down that road. It would vastly increase regulation on the industry and drive up costs across the board. This is why, as I have said, we have chosen to go down the route of best practice guidance instead. Best practice arrangements exist; they have been agreed with all parts of the supply chain and they have been very successful in minimising the impact of shortages. It is a much more flexible approach than statutory regulation.
In conclusion, I am grateful to the hon. Gentleman for raising this issue—one that will be relevant to all Members across all party divides, as well as to every single community and individual person. It is an issue of true universal interest and concern. I assure the hon. Gentleman that the coalition Government are absolutely committed to patients getting their medicines as quickly as possible. We are also certain that in the supply of medicines, everyone in the supply chain has their part to play, including manufacturers, wholesalers, pharmacists, prescribers and patients. The Government will continue to work closely with all those involved in the supply chain, making sure patients receive their medicines in a timely manner and without any unnecessary complications. This is not an issue that will be discussed just once and then forgotten. We are determined to keep a watchful eye on the situation to see if there are ways to improve it and minimise disruptions or problems for patients, ensuring that they get the best service, to which they are entitled.
Question put and agreed to.