Significance
The
provisions of the Trade-Related Aspects of Intellectual Property Rights
treaty (TRIPs) for pharmaceutical products have become a central issue
in the globalization debate since the Agreement came into force on January
1, 1995. Innovative pharmaceutical firms view the TRIPs Agreement as
correcting the deficiencies of pharmaceutical intellectual property
law in developing states that led to copying of products and reduced
profitability. At the same time, developing nations argue that intellectual
property rights protection for pharmaceutical products will entail substantial
financial and institutional costs, at the expense of public health.
In
a time of limited health budgets, policymakers in developing countries
worry that extending intellectual property rights protection to pharmaceuticals
may result in an increase in the price of pharmaceuticals.
A
number of other studies have examined the link between intellectual
property protection and pharmaceutical prices and concluded that substantial
price increases could result, however, the question remains unresolved.
This paper, supported by funding from the Pharmaceutical Researcher
and Manufacturers of America, takes another look at this controversial
issue.
Setting
and Assumptions
Rozek
and Berkowitz examine the link between movements in pharmaceutical prices
and changes in intellectual property protection in nine developing countries.
The study employs IMS data on pharmaceutical prices and sales for six
therapeutic classes of drugs between 1985 and 1996, a period during
which several countries first enacted intellectual property laws.
The
paper begins with a cursory review of the status of IP protection in
each of the developing countries during the 1985-1996 period. Of the
nine countries in the sample, five countries had intellectual property
protection in place (Korea, Mexico, Taiwan, Hungary, and Brazil), while
the remaining four were without (Argentina, Egypt, Jordan, and Turkey).
Methodologically,
the analysis examines price movements for three distinct samples of
products to answer three particular questions:
- a
set of the same drugs across all countries to examine whether countries
with IP protection in place have higher pharmaceutical prices than
those who do not,
- a
sample of the existing "original" pharmaceuticals (branded
products) in each of the nine countries to shed light on how the price
changes of a market basket of products compared to inflation, and,
- a
sample of all products in each country, identifying those introduced
before and after changes in IP protection, to examine possible price
variation associated with the change.
Results
In
this paper, Rozek and Berkowitz highlight results concerning the second
group of products. They argue that movements in the prices of branded
pharmaceutical products are largely unaffected by the institution of
IP protection, attributing this to four factors: patent protection only
applies to future products and does not retroactively cover existing
drugs, substitutes are available within therapeutic classes, government
purchasing (monopsony buyers) limits price increases, and price control
regulations constrain pharmaceutical prices.
This
result is hardly surprising. Since existing products are not
subject to patent protection, patents are not likely to cause their
prices to go up. To more directly address the fundamental concerns surrounding
higher pharmaceutical prices, slightly different questions need to be
answered.
And,
in fact, Rozek and Berkowitz shed some light on these two questions:
- Will
increased IP protection for pharmaceuticals result in higher introductory
prices for new pharmaceutical products? Without directly examining
this question, Rozek and Berkowitz suggest that the answer would be
‘yes’.
- Following
the institution of IP protection, does pharmaceutical spending increase
due to a change in consumption, that is, are cheaper locally-produced
copies increasingly replaced by higher-priced branded products? In
six of the nine countries studied, the analysis finds increased market
share for branded products and reduced market share for "other"
products, though the authors state that there is no evidence that
consumption systematically changes with intellectual property protection.