How Does Pharmaceutical Policy Affect The Pharmaceutical Industry

Generic drugs play a vital role in healthcare by improving accessibility as well as affordability of

drugs. Generic drugs occupy a significantly higher share of the drug market globally as compared to

reference drugs. The same is true even in developed economies of the world. It is important to take

a holistic view of the prevailing policy framework covering generic drugs globally, making it possible

to analyze the effects of these policies on the generic pharmaceutical industry.

The first pertinent area of global pharmaceutical policy is funding of research in life sciences. This

pertains primarily to reference drugs rather than generic drugs. Globally, there is no overarching

framework for the same. This is primarily done only in the event of a global challenge in the
Food and Drug Administration (FDA) and the European Medicines

Agency (EMA) for CGMP (current good manufacturing practice) violations.

Patent law is another area with regard to a divergence of interests between the developed and

developing world, thereby rendering it difficult for policy makers to converge on a common agenda.

The legal instrument driving international patent protection is the Agreement on Trade-Related

Aspects of Intellectual Property Rights (TRIPS) under the auspices of the World Trade Organization.

The TRIPS framework sets out minimal standards for intellectual property protection modelled after

those in developed nations with which all WTO members must comply. Patent law is already well

established for industrialized countries, so most of the efforts to comply with the TRIPS are

concentrated in the developing world.

Multinational pharmaceutical giants have challenged the validity of a key provisions the Patent laws

of developing countries on multiple occasions. These countries have legislative provisions to ensure

that frivolous 20-year patent monopolies are not granted at the cost of public health. Also,