Pharmaceutical policy

Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs (both brand name and generic), biologics (products derived from living sources, as opposed to chemical compositions), vaccines and natural health products. Pharmaceutical policy includes:

In many countries, an agency of the national government (in the U.S. the NIH, in the U.K. the MRC, and in India the DST) funds university researchers to study the causes of disease, which in some cases leads to the development of discoveries which can be transferred to pharmaceutical companies and biotechnology companies as a basis for drug development. By setting its budget, its research priorities and making decisions about which researchers to fund, there can be a significant impact on the rate of new drug development and on the disease areas in which new drugs are developed. For example, a major investment by the NIH into research on HIV in the 1980s certainly could be viewed as an important foundation for the many antiviral drugs that have subsequently been developed.

While patent laws are written to apply to all inventions, whether mechanical, pharmaceutical, or electronic, the interpretations of patent law made by government patent granting agencies (the United States Patent and Trademark Office, for example) and courts, can be very subject-matter specific with significant impact on the incentives for drug development and the availability of lower-priced generic drugs. For example, a recent decision by the United States Court of Appeals for the Federal Circuit in Pfizer v. Apotex, 480 F.3d 1348 (Fed.Cir.2007), held invalid a patent on the “pharmaceutical salt” formulation of a previously patented active ingredient. If that decision is not overturned by the United States Supreme Court, generic versions of the drug in controversy, Norvasc (amlodipine besylate) will be available much earlier. If the reasoning of the Federal Circuit in the case is applied more generally to other patents on pharmaceutical formulations, it would have a significant impact in speeding generic drug availability (and, conversely, some negative impact on the incentives and funding for the research and development of new drugs).

This involves the approval of a product for sale in a jurisdiction. Typically a national agency such as the US Food and Drug Administration (specifically, the Center for Drug Evaluation and Research, or CDER), the UK Medicines and Healthcare Products Regulatory Agency or Health Canada or Ukrainian Drug Registration Agency [1] is responsible for reviewing a product and approving it for sale. The regulatory process typically focuses on quality, safety and efficacy. To be approved for sale a product must demonstrate that it is generally safe (or has a favourable risk/benefit profile relative to the condition it is intended to treat), that it does what the manufacturer claims and that it is produced to high standards. Internal staff and expert advisory committees review products. Once approved, a product is given an approval letter or issued with a notice of compliance, indicating that it may now be sold in the jurisdiction. In some cases, such approvals may have conditions attached, requiring, for example additional ‘post-marketing’ trials to clarify an issue (such as efficacy in certain patient populations or interactions with other products) or criteria limiting the product to certain uses.

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