Health Action International - Europe

Response to the G 10 Medicines
High Level Group on Innovation and Provision of Medicines
Consultation Paper

HAI Europe wishes to respond to a number of key issues raised in the G 10 consultation paper. However, it would first like to raise concerns about the G 10 process and its membership. The fact that the pharmaceutical industry holds four of the 12 seats in the group reveals the strong industry bias reflected in its discussions and documentation. Had the group's composition been more balanced, it would have much more legitimacy among the stakeholders.

While HAI Europe applauds the G10's initiative to review pharmaceutical innovation and provision of medicines, it feels the very name of the high level group is troublesome. That is, the group's debate needs to be centred more on public health goals and not just on trade considerations if it is to live up to its mandate. At stake here is whether commercial interests or consumer health will be given priority.

Some specific issues of concern to HAI Europe

Section 2. "Information and protection of patients"

Consumers today are taking an increasingly active interest in their own health care. The public demands more and more information about health care options and available medicines. This development has led the research-based pharmaceutical industry to call for the legalisation of various types of drug promotion as a means of providing that information. HAI Europe believes drug promotion is not the same as objective information on drugs and other relevant treatments. One is intended to sell a product, the other to inform.

HAI strongly disagrees with the idea that the pharmaceutical industry "can play a crucial role as providers of reliable, factual and balanced information about their medicines to patients that will support the appropriate and effective involvement of patients and appropriate use of their products." The fact is that pharmaceutical companies have a fundamental interest in selling their products and not in providing objective, balanced and comparative information.

Drug company websites offering information about illnesses and specific medical treatments are usually provided in an attempt to market a drug or to increase the pool of potential users. It is highly unlikely that companies will provide information about illnesses that does not put their own treatment in the best possible light regardless of whether or not their drug is the best choice. One must also consider the fact that non-drug alternatives will not receive the priority that they deserve on such a site.

The EU pharmaceutical legislation review's proposal to allow companies to distribute drug information related to three types of chronic diseases will provide little contribution to balanced, comparative information. In fact, one of the patient groups affected by the proposal moved quickly to announce its opposition to it. The Insulin Dependent Diabetes Trust (IDDT), a group promoting the rights of consumers who have had adverse reactions to genetically produced "human" insulin has said "While we accept the need for consumers to have more information about prescription drugs, we believe this information should be unbiased and therefore it is inappropriate that it should be provided by industry whose understandable aim is profit."(i)

Consumers need access to more independent information so they can make better, informed choices about both drug and non-drug treatment options.(ii) However, little funding is available for the provision of this type of objective information. Industry groups argue that material they supply to consumers will fill this information gap. This argument forgets the fundamental difference between drug promotion, which aims to sell a product, and the kind of information needed to choose how best to treat a health problem. Given the industry's record on providing "information" to health professionals and the current need for the US Food and Drug Administration to forcefully monitor and object to numerous direct-to-consumer drug promotion campaigns carried out in that country (iii), the evidence suggests that this new proposal will only increase irrational prescribing and use.

HAI Europe strongly opposes the Commission's proposal to allow industry to distribute information on selected illnesses. As we have said in the past to the European Commission (particularly in response to DG Enterprise's questionnaire on advertising and e-commerce, we call for a moratorium on the question of direct-to-consumer promotion until the Commission and the pharmaceutical industry can provide evidence showing health benefit and lack of harm.

Section 2.15 "providing core funding for European patients groups"

The competition for funding among NGOs operating in the EU often puts public interest health groups at a disadvantage. Funding shortages result in their voices being lost during key policy discussions on pharmaceuticals in the EU. HAI Europe supports the proposal to provide core funding for public interest health groups operating within the region. However, it strongly objects to the EU's funding of patient groups that receive industry funding or that operate in conjunction with industry. Such groups only serve to magnify industry's own voice.

Section 5.2 "Competitiveness, benchmarking and innovation"

In the past few years, public interest health organisations including Public Citizen, the Consumer Project on Technology and Médecins Sans Frontières (iv) have all published evidence opposing the research-based industry's argument that research and development costs are extensive. The fact is that few medicines on the market are the product of innovation and new research. A recent survey showed that of the 2257 new prescription products or indications marketed in France between 1981 - 2000, only 74 were major therapeutic advances.(v) Many new medicines have been developed using public funding. HAI believes that this R&D defence is often used by the industry to justify higher drug prices.

Section 5.7 "Monitoring progress/benchmarking"

The G10's insistence on measuring progress by counting drugs on the market and consumers' access to them seems short-sighted from a public health perspective. The G-10's firm wish to increase "innovation" does nothing to distinguish between true therapeutic advances and the industry's efforts to churn out more drugs for the market, many of these actual "copycats or me-too" drugs which offer little or no therapeutic benefit.

Public health policy at the national level is often better served conversely by not promoting innovative medicines as these are often the most costly and those with the least known risk profile. Generic drugs also have an important role to play in providing needed medicines to European consumers. The definition of innovation given in section 6.5 "to ensure that patients have access to high quality medicines and innovative treatment that improves existing therapy and addresses unmet patient needs" is more appropriate.

Section 6.1 Single market, market access and fragmentation

HAI Europe is alarmed by the consultation paper's assertion that medicines are "ordinary goods". Most medicines are potentially highly toxic and can kill, unlike most consumer goods. For this reason, patients are unable to access prescription medicines without consulting an expert intermediary (i.e. doctor).

Because medicines are not ordinary goods, regulatory procedures are put in place to ensure medicines meet acceptable standards for safety, quality and efficacy. No regulatory procedures should be introduced that may compromise patient safety e.g. fast-tracking applications for marketing authorisation as proposed by the Commission (6.11).

The fact that this consultation paper has been circulated, the G10 has been created and the entire pharmaceutical reform package is so complex and lengthy demonstrates that medicines are anything but ordinary products. Medicines demand special consideration because of their impact on public and personal health.

HAI Europe has attached two background documents: "Is the EU edging towards DTCA? Examining the consequences of industry's latest lobby" and Blurring the Boundaries: New Trends in Drug Promotion to provide more information about its concerns on drug promotion targeted at consumers.

Health Action International (HAI) is a network of more than 200 consumer, health, development action and other public interest groups involved in health and pharmaceutical issues worldwide.

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