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Health technology assessment (HTA) brings together information from a wide range of sources and results in an evidence-based evaluation of technology. It is the results of HTA, which provide information to improve clinical practice, health policy and administration.
In the United States, it has become common for litigation to be used to challenge clinical practice and health-related administrative decisions. Now, this trend may be spreading to other parts of the world.
In the past, large pharmaceutical companies have tried to use the courts to stall or change decisions that could influence the marketing of their products. For example, Bristol-Myers-Squibb Canada Inc. tried to prevent the Canadian Coordinating Office for Health Technology Assessment from releasing a statement on statins (drugs that reduce blood cholesterol levels) which would indicate that all statins are beneficial as part of a “class effect”. The company pointed out that clinical trials have only been performed on two statin drugs and as such a “class effect” cannot be substantiated. By going to court, it hoped to delay or ultimately prevent the information from being released. The costs of such litigation are enormous with legal fees often reaching around 13% of the government agency’s annual budget. Moreover, there is a drain on the limited human resources of the HTA.
In a related case, litigation has delayed the work of two Finnish researchers who received documentation from the Finnish Ministry of Health on Leiras’s Norplant, a slow-release levonorgesteral capsule used for contraception. Their report, which showed that the release of Norplant in 1993 was premature by current standards, has remained unpublished due to legal action taken by the manufacturer against the Ministry of Health. Leiras sued the Ministry for releasing confidential data. The researchers fear that the Ministry may choose not to release such information for research in the future due to the threat of litigation.
HTA aims to provide a synthesis of information from different disciplines and often uses incomplete and varied data. It is these very traits which enhance the threat of legal attacks. If HTA is to be held legally and financially responsible for the outcomes of its research there are four potential consequences. Firstly, HTA can expect lawsuits from those who stand to suffer financial loss from results of its research. Secondly, HTA stands to lose the financial support of research institutions and funding agencies declining to finance research they think carries legal risks, resulting in self-evaluation by the industry. Thirdly, governments may be deprived of impartial expert advice which could result in actions to reduce their own risks and reduce evidence-based findings. Fourthly, well-publicised court cases will reveal to the public the financial interests of the health technology industry, putting into perspective decisions made on health technologies.
Some recommendations put forward to solve the problems include:
(Science, vol. 285, 9 July 1999)
In March of this year the European Medicines Evaluation Agency proposed publishing summaries of the Committee on Proprietary Medicinal Products (CPMP) opinions immediately at the time of adoption, rather than 60 days later which had been past practice. In the case of a negative opinion a “brief statement on the major grounds for refusal of the marketing authorisation” would be provided. Currently, the EMEA does not provide details of reasons behind negative opinions.
It was agreed that, starting in July 2000, summaries of opinion (both positive and negative) will be published 15 days after the adoption of CPMP opinions. This allows for appeals to take place before the decision is made final and published.
Seven bodies responded to the EMEA announcement including HAI and the International Society of Drug Bulletins (ISDB). (The full replies can be found on HAI’s website at: http://www.haiweb.org/news/news.html). In its response, HAI voiced a fear that the number of pre-emptive withdrawals would increase as companies attempted to prevent the negative opinion becoming public knowledge. Others said competitors in the pharmaceutical industry could use the availability of early information to their advantage.
(PJB Publications, March 8th 2000, PJB Publications, April 14th 2000 and Letter to EMEA from HAI Europe, March 2000)
Before the Portuguese Presidency of the EU ended in June, public health advocates from across the region met in Lisbon in April for the European conference “Medicinal products and public health: The Amsterdam treaty and the future of the European System of Authorisation and Supervision of Medicinal Products”.
The Portuguese Presidency took place at a time of change within the community’s framework on public health. Its main aims were to evaluate the performance of the European System of Authorisation and Supervision of Medicinal Products, to evalue the impact of medicines on public health, the accessibility of medicines, and information on drugs for consumers and health professionals.
Representatives from Member State governments, international organisations and civil society, discussed these issues and others now that the community’s public health competence has been broadened by the Treaty of Amsterdam. The new situation implies the need to consider protection of public health in all EU policies. It also offers new ways for the Community to intervene in the pharmaceutical sector. These changes mean that health policy will involve both the DG Enterprise and well as the newly established DG Public Health and Consumer Protection on issues related to medicines.
The conference took place while a review of the European System of Authorisation and Supervision of Medicinal Products is underway. A Commission report on the system is expected by the end of the year.
For more information about the conference and a summary report, contact INFARMED (the National Institute for Pharmacy and Medicines, Parque da Saúde de Lisboa, Av. do Brasil, 53-1749-004 Lisbon, Portugal, e-mail: p2000@infarmed.pt or visit its website: http://www.pt2000.infarmed.pt.
(Summary and conclusions of the Conference, Lisbon 11-12 April 2000)
Clinical researcher Dr. Nancy Fern Olivieri, has spoke out against the EU’s decision to approve a drug she believes raises safety concerns. (Olivieri made headlines a few years ago when she tried to warn patients and the medical community about a new treatment she was testing for thalassaemia, a rare blood disorder. When she decided to announce that the drug did not work as well as expected and that some children in her study developed serious side effects, she was threatened with legal action by the company if she made her findings public. Her own employer, the University of Toronto teaching hospital, refused to back her and it was later revealed that the hospital was in the midst of negotiating a charitable donation from the drug’s manufacturer.)
In August 1999, the Committee for Proprietary Medicinal Products (CPMP) of the EU issued a marketing authorisation to Apotex for marketing Deferiprone. In April 1999, when Olivieri was informed of the pending approval, she wrote to the European authorities informing them that two Canadian trials had been abruptly terminated and that she believed that Apotex’s application contained inaccurate information. She also referred to serious adverse effects which had not been reported to the European authorities. After a short delay, the Commission issued the authorisation. In November 1999, Olivieri filed an application for immediate suspension of the authorisation and also filed legal action against the Commission claiming that her reputation would be damaged if the product remained on the market.
In April 2000, the European Court of First Instance rejected Olivieri’s attempt to halt marketing of the drug in the EU. The court concluded that Olivieri had failed to prove that patients would be at risk and that her reputation would be tainted if the product remained on the market. The court felt that there was insufficient reason to withhold authorisation. It ruled that under exceptional circumstances in which untreated thalassaemia patients could die, Deferiprone should be used. The Commission also pointed out that doctors were to be informed of potential risks of the drug and that Apotex had accepted the conditions placed by the court including providing sales figures in each member state.
The uniqueness of this case lies in the fact that the European Commission’s procedures do not provide an appeal procedure on issues of fact or law. In fact to date, only aggrieved manufacturers have challenged a negative or restrictive decision and this is the first time that a positive European regulatory decision has been challenged in a court of law. In effect this suggests that the public interest in drug control is overlooked. Thus if a positive decision is made incorrectly, resulting in the licensing of a potentially dangerous/damaging drug there is no way that the public can recognise the error and appeal. Indeed most of the investigational material available is unpublished and only the authorities and the manufacturers can read it.
(International Journal of Risk and Safety in Medicine: Lawnotes and Scrip No 2531 14 April 2000)
After six years as the Executive Director of the European Agency for Evaluation of Medicinal Products (EMEA), Fernand Sauer has been nominated as director responsible for public health policy in the EU’s Directorate-General for Health and Consumer Protection (DG Sanco) as of 1 December 2000. His successor at the EMEA will be appointed in late September 2000.
(EMEA communication, 28 June 2000)
