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Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available. [ABSTRACT FROM AUTHOR]

The high cost of patent-protected brand-name drugs can strain budgets and curb the widespread use of new medicines. An example is the case of direct-acting antiviral drugs for the treatment of hepatitis C. While prices for these drugs have come down in recent months, they still create barriers to treatment. Additionally, prescribing restrictions imposed by insurers put patients at increased risk of medical complications and contribute to transmission of the hepatitis C virus. We propose that the federal government invoke its power under an existing "government patent use" law to reduce excessive prices for important patent-protected medicines. Using this law would permit the government to procure generic versions of patented drugs and in exchange pay the patent-holding companies reasonable royalties to compensate them for research and development. This would allow patients in federal programs, and perhaps beyond, to be treated with inexpensive generic medicines according to clinical need--meaning that many more patients could be reached for no more, and perhaps far less, money than is currently spent. Another benefit would be a reduction in the opportunity for companies to extract monopoly profits that far exceed their risk-adjusted costs of research and development. [ABSTRACT FROM AUTHOR]

The article discusses the effect of Trade-Related Aspects of Intellectual Property (TRIPS) Agreement for the enforcement of high minimum standards of intellectual protection (IP) protection in India. TRIPS is the most important part of IP treaties, which requires the of the World Trade Organization (WTO) to adopt and enforce high minimum standards of IP. TRIPS also serves as the harmonizing force for formal flexibility in pharmaceuticals sector in the country.

The article offers the author's insights on the landmark ruling of India's Supreme Court on the Novartis v. Union of India and Others case regarding the patent law 2.0, which can align innovations in pharmacy medicine with the health needs of the public. The author discusses the disadvantage of patents and the problems that arise on wrong kind of patent protection. She mentions that the decision of the court indicates that India can denied drug patents despite the U.S. approval.

This Viewpoint discusses legislative efforts at the state level to monitor or regulate drug prices and reviews legal challenges raised by industry in response to these efforts. [ABSTRACT FROM AUTHOR]