Access to medicines in the context of the right-to-health framework 2013, para. 63
Paragraph- Paragraph text
- Accessibility of information with respect to the quality, safety and efficacy of medicines is necessary for the enjoyment of the right to health. Before acquiring marketing approval, pharmaceutical companies are legally required in most countries to provide data demonstrating the safety, quality and efficacy of new medicines, generated from medically and ethically valid clinical trials. However, during the Special Rapporteur's consultations, diverse stakeholders noted non-transparency of clinical trial data as a concern. Trial data is not made public by pharmaceutical companies and regulators on the ground of protecting commercial information. Moreover, data relied upon for registration of medicines is often subject to publication bias (only positive results are published or are overrated), which is misleading and potentially harmful for patients. The Special Rapporteur notes with satisfaction that national and regional regulatory bodies are taking steps to make this data available through clinical trial registries. However, critics still point to content and functionality shortcomings in these registries. The Special Rapporteur encourages States to take regulatory measures to ensure that information on the safety, quality and efficacy of medicines, even if negative, is made publicly available in functional trial registries.
- Legal status
- Non-negotiated soft law
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Means of adoption
- N.A.
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
- Paragraph type
- Other
- Reference
- SR Health, Report to the HRC (2013), A/HRC/23/42, para. 63.
- Paragraph number
- 63
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