A/63/263 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. 20 08-45647

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