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Medicine Purchasing

11.24 am

Dr. Ian Gibson (Norwich, North): The internet has given millions of people worldwide access to medical information and products in unprecedented volumes. It is becoming increasingly evident that many internet sites do not conform to United Kingdom standards. There are more than 20,000 health-related websites, with an increasing number selling powerful drugs that would normally be available only on prescription in the United Kingdom. Other products on offer include over-the-counter medicines, and vitamins, minerals, functional foods and herbal remedies, for which medicinal claims are made. New developments based on genome research will not only increase the number of medicines available. In the future, techniques such as gene testing and genome sequencing will be offered directly to the public via the internet and the situation could thus become increasingly complex.

At present, 7 million or so people in this country have home internet access and 45 per cent. of the United Kingdom population has used the internet at least once. Those figures will almost definitely increase in the near future, especially with the wider availability of new devices such as digital television, WAP phones and the later computer games consoles, all of which offer internet access. In the United States it has been predicted that the domestic market for online health services will increase from $200 million in 1999 to $10 billion in 2004--a 50-fold increase. In recent months, Pharmacy 2U, the first United Kingdom online pharmacy, has been launched. Both the British Medical Association and the National Pharmaceutical Association have expressed reservations about such developments.

The Government have taken e-commerce on board as one of the key elements for the United Kingdom's future in trading development, with a target of bringing the entire nation on line by 2005. However, specific areas of e-commerce, particularly those related to public health, will need more stringent validation processes to prevent malpractice. The number of relevant sites is likely to increase in coming years, which gives rise to several concerns. Consumers who bought prescription drugs from unregulated online websites could bypass medical advice before and after purchase and thus be at risk from the adverse affects of inappropriately prescribed medications, dangerous drug interactions or contaminated drugs, not to mention the issue of confidentiality of medical information.

Customers in the United Kingdom can purchase goods from overseas sites, some of which provide no contact details. That is a matter of concern in the light of potential negligence. Internet users should also be aware that products with the same name may contain different ingredients in different countries and that countries may apply different laws on what medical products can be sold and shipped across national borders. That means that it is possible that products that are not approved for marketing in the United Kingdom, or which have been identified as a hazard to public health, may not be allowed into the country, if they are identified at entry. That would leave the customer without the option of reimbursement.

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Obtaining a prescription drug by filling out a questionnaire and without seeing a doctor poses serious health risks. A questionnaire does not provide sufficient information to enable a health care professional to determine whether a drug is suitable, or whether another treatment would be more appropriate. It might not pick up an underlying medical condition that might make a drug harmful. An associated danger is that, once the questionnaire has been provided to the supplier, the customer has no control over the confidentiality of the records. A recent study by Health Which?, a Consumers Association publication, showed that some prescription drugs--Viagra and Xenical--were sold when, for medical reasons, they should not have been. That happened despite the fact that the information supplied in the questionnaires should have been sufficient to justify refusing the drugs. The research also highlighted the fact that in some cases the consumer could not gain access to information on the professionals who were in charge of issuing the prescription. One site was simply signed off in the name of "Your family doctor". In a society in which health professionals register with official bodies and accept an ethical and moral code of practice, that behaviour is surely unacceptable. Similar results were reported in a study carried out in the United States in 1999.

What can be done? The American Medical Association has issued guidelines for the development and posting of website contents to govern the acquisition and posting of online advertising and sponsorship, which will ensure site visitors' and patients' rights to privacy and confidentiality and provide effective and secure means of e-commerce.

In March, a 52-year-old man with a history of heart disease died in the United States of America after buying Viagra online. Following that, the Clinton Administration proposed an additional $10 million investment to target and punish those who engage in illegal drug sales over the internet. That strategy will establish new federal requirements for all internet pharmacies to ensure that they comply with state and federal laws. It will create new civil penalties for the illegal sale of pharmaceuticals and give federal agencies, including the Food and Drug Administration, new authority swiftly to gather information needed to prosecute offenders. It will also expand federal enforcement efforts and launch a new public education campaign about the dangers of buying prescription drugs online. The National Association of Boards of Pharmacy has unveiled its verified internet pharmacy practice sites programme, which provides consumers with valuable information about the credentials of online pharmacies.

In the US, the FDA has issued warnings about purchasing from sites outside US jurisdiction. In the United Kingdom, the Royal Pharmaceutical Society and the Medicines Control Agency have provided assistance to community pharmacists on commonly encountered aspects of the internet and e-commerce, such as confidentiality, encrypted data transmission, provision of professional advice, comprehensive information on products and home delivery of medicines.

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The intrinsic nature of the web is the provision of worldwide services, which opens up fantastic possibilities for the consumer. However, that translates into obvious difficulties in the regulation of services provided. The fact that the content of web pages cannot be regulated shows that alternative measures for quality control must be put in place. Immediate ones could be the creation of a validation scheme for online health-related purchases through kite marking, guaranteed widespread access to a listing of sites and confidentiality of data.

Internet providers of health-related services should comply to quality standards, which should be the product of discussions between all the professional bodies involved, including the Department of Health, pharmaceutical societies, on-line businesses, consumer associations and so on.

While keeping consumer choice prevalent on the agenda, we must guarantee quality. The internet could be a powerful tool for delivering health care services. However, we should keep in mind the fact that guidance from the internet should not be used as a replacement for consultation with the consumer's health care provider. Guidance has been issued not only at a national level, but as a result of international attempts to provide the possibility of an informative choice to the internet user. That is true of the guide issued by the World Health Organisation in 1999. That was developed not only for consumer information but to serve as a model for member states to adapt into locally meaningful advice for internet users, to help them to obtain reliable, independent and comparable information on medicinal products.

Do consumers have easy access to those guidelines? The provision of internet links between health information sites, such as NHS Direct, as well as institutions governing aspects related to the provision of medicines, would facilitate access to safe online traders. At present, most attempts to regulate and validate such sites are at the initiative of the industry itself. For example, in the UK the Association of the British Pharmaceutical Industry is considering a paper on internet trading. Some work has already been done on advertisement of medicines on internet sites. Parallel to that, the first meeting between stakeholders will take place on Monday 17 July, which is next week, in the presence of the chief pharmacist and members of the RPS, the Proprietary Association of Great Britain, the Doctor Patient Partnership, the Royal College of General Practitioners and the UK on-line pharmacy Pharmacy 2U. It will be some meeting. The British Standards Institute has facilitated the meeting. However, Departments should take a proactive approach to promoting dialogue and regulatory initiatives.

In the light of those developments, will my hon. Friend the Minister outline the steps that her Department and agencies such as the MCA are taking to tackle those problems? Do they have any plans to take an active role in co-ordinating the various schemes being considered by the ABPI and other organisations?

11.34 am

The Parliamentary Under-Secretary of State for Health (Ms Gisela Stuart ): I congratulate my hon. Friend the Member for Norwich, North (Dr. Gibson)

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on securing the debate. The electronic purchase of medicines is a matter of increasing concern, and I welcome the opportunity to respond on the issue. As my hon. Friend has said, use of the internet is increasing at a pace that few would have anticipated. There are now at least 12 million internet users, and that figure is growing daily.

Electronic commerce, or e-commerce, lies at the heart of the Government's vision of a modern, knowledge-driven economy in the UK. That is why we are planning to make Britain one of the world leaders in e-commerce by 2002. E-commerce can bring major benefits to the public by providing wider choice and easier access to a vast array of products and information. However, more information does not always bring benefits; we must make sure that the information is reliable. It also sometimes takes time for the law to catch up with new developments. I remember from my days as a law undergraduate how long it took contract law to catch up with the availability of telephones and then fax machines, for example. Development of the law and of technology should happen in parallel.

The increased use of e-commerce should be balanced with the provision of essential safeguards for consumers, and that is particularly important for medicines. The availability of medicines on the internet is underpinned by controls on their advertising, promotion and sale. Before my hon. Friend entered Parliament he had a distinguished academic record and he knows only too well the importance of relying on scientific advice and ensuring that what is offered to the public for sale is safe.

In recent months, there has been a rapid development of internet sites offering medicines for sale. It is easy to see how such developments can offer advantages to people who find that shopping medium more convenient and attractive, but safeguards must be in place. We recognise that medicines are not like ordinary items that can be purchased on the net, such as clothing, electrical goods and jewellery. Everyone who buys a medicine, through whatever medium, must have medication that is appropriate to his or her condition.

A well-established framework of domestic and European law, providing safeguards to the public, is already in place. In particular, medicines are categorised on grounds of safety into those that can be used with or without medical supervision. In the case of prescription-only medicine, a doctor's or dentist's prescription is required, which provides an important safeguard. In addition, prescription-only and pharmacy medicines must be sold under the supervision of a qualified pharmacist, on premises that are registered and inspected by the Royal Pharmaceutical Society. General sale list medicines provide convenient access for some products that safely provide symptomatic relief for minor conditions and they can be sold by any general retailer if the premises are lockable and the medicine is in an unopened manufacturer's pack.

In addition to those legal controls, there are professional safeguards. In the past year, the UK's first true internet pharmacy sites have opened. The Royal Pharmaceutical Society has published interim standards specifically for internet pharmacy which make clear that pharmacists selling medicines online must exercise precisely the same care in supplying medicines as their colleagues working in other locations. It is part and

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parcel of a pharmacist's role, in any setting, that they have sometimes to refuse to sell people medicine if, in their professional opinion, it would not be safe or right to do so. That is an important safeguard. The safeguards already in place make it an offence to sell, rather than buy, medicines inappropriately. We put the responsibility clearly on the supplier.

There has been debate within the retail pharmacy world about the rights and wrongs--for commercial and ethical reasons--of internet-based pharmacy. What is clearly emerging from that debate is that some pharmacists believe that they can offer a fully professional service, which consumers and patients will trust and want to use, on the internet. Further safeguards are provided by the controls, through British and European Community law, on advertising. Those completely prohibit the advertising of unlicensed and prescription-only medicines to the general public. Although non-prescription medicines can be advertised, there are restrictions on the advertising of medicines for certain serious conditions. Those regulations apply as much to the internet as to any other medium.

The rapid development of e-commerce has encouraged, in parallel, an equally rapid development in electronic advertising and promotion through a variety of websites. That challenges the existing European legal framework, which was negotiated and implemented in the late 1980s when e-commerce and the use of the internet by European Union citizens was in its infancy.

The growth of e-commerce has prompted the European Commission to review the existing legislative framework. The United Kingdom is playing a leading role in the review, as a leading player in e-commerce and the internet. Our input will take account of the discussions that the MCA is having with other regulators involved in advertising control, industry and consumer groups. We will not ignore the agency's public health responsibilities while the European review of advertising and e-commerce is under way.

Our plan is not to limit the availability of useful information about medicines. We want to encourage the provision of good quality information and health care to consumers. Existing law already permits the provision of health information and the internet can play a leading role in that. For example, the right remedy campaign this winter empowered the patient by making more information available. The Government have told people clearly that there are many sources of advice, including pharmacists and NHS Direct.

As part of the Government's "Information for Health" strategy, a programme of work is in place to give public, patients, and health care professionals access to NHS accredited sources of information. That information comes not only from the NHS but from patient groups, from which people can learn about long-term conditions. However, we recognise our responsibility, and a source that has an NHS label is reliable and has been tested. Such information can make a significant contribution to ensuring that medicines are taken safely and effectively.

The hon. Gentleman must be aware of the telephone help line, NHS Direct. Last December, the Prime Minister launched NHS Direct online, which represented an important step towards making accredited information available on the internet.

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Experience gained from the help line is transferred to the online service, which is one of the most popular and best regarded health websites in the United Kingdom and provides a gateway to accredited information on the internet. Sex, religion and health are the three most searched-for areas on the internet. There is a lot of information about health, but some of it is extremely unreliable. The online service provides links to several hundred accredited sources of information on the internet and other formats. Users can feel confident that the information that they access will be reliable and of good quality.

I come now to the question of enforcement--the criminal investigation of alleged breaches of medicine regulations that can lead to prosecutions in the criminal courts. If a defendant is found guilty, the maximum penalties are two years' imprisonment and/or an unlimited fine. Powers also exist, and are used, to confiscate assets and seize and destroy products.

That work is also carried out on behalf of Ministers by the MCA's enforcement group, which is a team of highly trained and experienced investigators. The MCA works closely with other enforcement agencies here and overseas. In particular, the MCA has close ties and workings with the Food and Drug Administration's Office of Criminal Investigation, which investigates internet crime related to pharmaceuticals. My hon. Friend referred to the Clinton Government's initiative aimed at effectively controlling and policing the internet. We were pleased that that initiative was backed up by a substantial financial commitment. That is important, as about 75 per cent. of overseas websites potentially advertising prescription-only or pharmacy medicines in the UK are based in the USA. As such a close link exists, it is important for us to work together. The MCA's enforcement arm is also accredited to the National Criminal Intelligence Service. The MCA has an impressive track record and is recognised as a world leader in the successful investigation of pharmaceutical crime.

In response to the growing significance of the internet, the MCA has set up a special unit within its enforcement group whose work is to investigate possible breaches of regulations on the internet. Officers have received special training in web search techniques and investments have also been made in search engines and other specialist equipment that may be required. As a result of their investigation, action has already been taken against a number of websites that have been in breach of the law. Those breaches have involved both licensed and unlicensed medicines. Some websites have been closed down, while others have had to amend their web pages to comply with the law.

In the case of subversive, covert or apparently deliberate criminal acts, the MCA may attempt enforcement immediately through the criminal courts.

I assure my hon. Friend that mechanisms and the legal framework already exist to ensure that the interests of public health are met.

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When the business is located in the UK, direct action by the MCA is relatively easily achieved.

Dr. Gibson : Is my hon. Friend aware of how many such prosecutions there have been? Has there been one or more?

Ms Stuart : There have been a couple of prosecutions, and several are in the pipeline. I would be happy to provide my hon. Friend with precise figures. It is important to recognise that those who attempt to subvert often do so opportunistically, so the threat of action, or simply the process, often displaces them.

What happens when, as is not unlikely on the internet, the perpetrator is abroad? The market is increasingly becoming global. Although our experience is that there is often a UK base or business presence in the UK of some description, the perpetrator is more frequently an opportunist trader--a criminal seeking to make easy and quick money and evade the law.

In such situations we can and do seek the assistance of colleagues in other countries. In 1999, senior pharmaceutical law enforcement officers from 12 countries met in Ottawa and set up a permanent body known as the International Forum on Pharmaceutical Crime to foster the coming together of enforcement groups from different countries to enforce pharmaceutical law. The MCA was asked to provide support and act as a co-ordinating point for the forum's work, and was glad to do so. High on the list of the forum's policy objectives is a strategy for developing practical enforcement measures against criminal activities on the internet involving pharmaceuticals. As crime and illegal activities become increasingly international and use the most modern technology it is necessary to work in a co-ordinated fashion.

I assure my hon. Friend that we are committed to maintaining and developing existing enforcement capabilities so that, where the protection of public health requires it, the full weight of the law can be brought to bear swiftly and effectively.

What is the driving force behind e-commerce, making the internet available and providing information? We have no problem with the use of e-commerce; indeed, we encourage it. We want people to trade on the internet, and take the opportunities that it provides. However, as I said at the outset, medicines are a different matter. Consequently, we have placed specific responsibilities on suppliers. As a Government, we must ensure that the framework that we end up with is one that protects our citizens, provides them with reliable information, and, furthermore, provides them with the means to establish whether information is reliable. NHS Direct and NHS Direct online have been significant developments in that regard. In the light of rapid technological developments in the marketplace, the legislative framework must be examined to ensure that it meets the needs of the public and, in particular, strikes the correct balance between patient empowerment, ease of availability of medicines and adequate protection of public health. However, as I explained earlier using the analogy of contract law, it can take a long time before the legal framework is right.

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It is also important to recognise that the process is evolutionary, in which, especially in light of the international dimension, we work with the other agencies involved to create a system that will not allow evasion or create loopholes or conflict and will co-ordinate action. I hope that my hon. Friend will be reassured that we are including in the strategy not only stakeholders and the pharmaceutical industry but, more important, patient groups, because ultimately the failure or success of the strategy will be judged by whether patients have been adequately protected. It is on that basis that negotiations proceed.

I assure my hon. Friend the Member for Norwich, North that we are committed to striking the right balance. Effective regulation, enforcement and the provision of good-quality information are crucial to realising that aim. I am deeply grateful to him for having raised the issue. Something makes me feel that this may not be the last time that we discuss the issue in the House.

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