Paper short abstract:

The use of the intellectual property (IP) and regulation to check the competition to maintain market dominance and profit. This paper examines the above strategy in the light of the WHO process to remove counterfeit medicione discussions.

Paper long abstract:

Pharmaceutical regulation is viewed as a scientific and technical issue and each stakeholder participating in the WHO process has its own interest in the issues. There is an absence of an agency to bring a more holistic approach by bringing the public interest aspects like political, economic, human rights analyses of the pharma regulation. Often discussions miss the historical evolution of the issue. The academic researcher could be able to bring these aspects to the attention of various stakeholders including the negotiators. The social science research outcomes often fail to provide influence with the WHO's norms and standard-setting process on pharmaceutical regulation.

Pharma regulation is accepted as a science and accepts it as it is without any interrogation. Researchers need to understand that regulation is not science but a set of norms and standards backed with certain scientific reasoning. This scientific rationale changes as science progress but the norms and standards may not necessarily follow the same speed. Further, like any norms and standard-setting process such as legislations pharmaceutical regulation is also susceptible to the influence of dominant actors. Therefore the assumption of regulation as science could lead to sub-optimal methodologies.

It could be improved :

• Following the process as an observer to understand the process

• Understanding the research gap in terms of evidence

• Identification and mapping of key stakeholders, which includes WHO staff

• Formal and informal interactions with stakeholders

• Dissemination of research outcomes including Briefing of research outcomes to various stakeholders including negotiators