Senator Bernie Sanders (I-VT) has offered an amendment to the health care reform bill that would eliminate data exclusivity in cases where duplicating clinical trials involving human subjects would violate Article 20 of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human subjects . The relevant article from the Declaration of Helsinki reads as follows:
20. Physicians may not participate in a research study involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians must immediately stop a study when the risks are found to outweigh the potential benefits or when there is conclusive proof of positive and beneficial results.
In a new section of the health reform bill on "Ethical Pathway for Pharmaceutical Products," the amendment would require the Secretary to create a new cost-sharing arrangement, in cases where the replication of a clinical trial would present human subjects with risks, simply to establish something that is already known -- that a drug is safe and effective. The details of the cost sharing would be determined by rules adopted to implement the amendment.
The issue addressed by the amendment has long been of interest to public health groups , on the grounds that regulatory rules providing exclusive rights in clinical trial data violate medical ethics.
In May 2008, the World Health Organization (WHO) World Health Assembly (WHA) passed a resolution that called upon governments to respect the Declaration of Helsinki in designing regulatory policies:
WHA61.21: Global strategy on public health, innovation and intellectual property
Element 6. Improving delivery and access
(6.2) establishing and strengthening mechanisms to improve ethical review and regulate the quality, safety and efficacy of health products and medical devices
(g) promote ethical principles for clinical trials involving human beings as a requirement of registration of medicines and health-related technologies, with reference to the Declaration of Helsinki, and other appropriate texts, on ethical principles for medical research involving human subjects, including good clinical practice guidelines.
The Sanders amendment would be the first time a government has recognized the conflict between medical ethics and regulatory procedures that demand unnecessary clinical trials on human subjects.
The WTO TRIPS agreement and several U.S. free trade agreements speak to the issue of "unfair commercial use" of data uses to register pharmaceutical products. The relevant provision in the TRIPS is Article 39.3, which reads as follows:
SECTION 7: PROTECTION OF UNDISCLOSED INFORMATION
3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.
Public health groups has long argued that this provision in the TRIPS only refers to "undisclosed information," and that any concerns over unfair commercial use of clinical trials data is more appropriately addressed through cost sharing agreements, rather than through the creation of temporary exclusive rights.
Regulatory requirements now provide that for a period of time, generic drug companies must replicate clinical trials, even when there is no scientific benefit of the experiment. Amendment 2858 would essentially change this, and effectively eliminate data exclusivity. It would not change the status of products protected by patents, and it would require cost sharing if a generic company relied upon clinical trial data, during the period of data protection.
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