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 …show more content…
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,
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 …show more content…
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,