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international law and practice. The disclosure should extend to amounts,
beneficiaries and channels by which the support is provided.
19. When providing any financial or other support, the company should
require all recipients to publicly disclose such support on all appropriate
occasions.
Commentary: Like many other businesses, pharmaceutical companies devote
considerable resources to advocacy, lobbying and related activities. While some of
these activities may impact positively on access to medicines, for example, lobbying
to lower taxes on medicines, other activities may impact negatively. Guidelines have
already emphasized, in general terms, the central importance of transparency in
relation to access to medicines (Guidelines 6-8). Guidelines 17-19 apply this general
principle of transparency to the specific context of public policy influence,
advocacy and lobbying.
Quality
20. The company should manufacture medicines that comply with current
World Health Organization Good Manufacturing Practice Guidelines, as well
as other appropriate international regulatory requirements for quality, safety
and efficacy.
Commentary: Guideline 20 reflects the elementary right-to-health requirement that
all medicines must be of good quality, safe and efficacious.
Clinical trials
21. A company’s clinical trials should observe the highest ethical and human
rights standards, including non-discrimination, equality and the requirements
of informed consent. This is especially vital in those States with weak
regulatory frameworks.
22. The company should conform to the Declaration of Helsinki on Ethical
Principles for Medical Research involving Human Subjects, as well as the
World Health Organization Guidelines for Good Clinical Practice.
Commentary: The right to the highest standard of health encompasses medical
ethics. Guidelines 21-22 emphasize the right-to-health responsibility of
pharmaceutical companies to observe the leading international standards on ethics
and clinical trials. Guidelines 9-14 emphasize the importance of effective,
transparent and accessible monitoring and accountability mechanisms; these
mechanisms should monitor, and hold to account, pharmaceutical companies in
relation to their policies and practices on clinical trials.
Neglected diseases
23. The company should make a public commitment to contribute to research
and development for neglected diseases. Also, it should either provide in-house
research and development for neglected diseases, or support external research
and development for neglected diseases, or both. In any event, it should
publicly disclose how much it contributes to and invests in research and
development for neglected diseases.
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