Public health has once again taken centre stage in world trade issues with the chief of the US Food and Drug Administration (FDA) Margaret Hamburg recently preaching vociferously about the quality of the medicines that can be exported to the US. Medicines that do not conform to FDA standards are not to enter the US market. Elsewhere, though, the affordability of public health has become a vital concern, especially in the wake of major epidemics like HIV/AIDS, malaria, tuberculosis and a host of other diseases. More so after public health came under the trade related intellectual property rights (TRIPS)
regime under the WTO.
The interface between TRIPS and the objective of universal and equitable access to public health caught the attention of the world in 2001 during WTO’s development round of negotiations, called the Doha Round. The overriding importance of this subject could be gauged from the fact that there was a separate Ministerial Declaration on TRIPS and Public Health at the time of announcement.
The TRIPS agreement for the first time in 1995 set down minimum standards and universally applicable benchmarks on intellectual property (IP) to be administered on all WTO member countries.
While a certain relaxation in implementation was given to developing countries and least developed countries as they were in a nascent state of IP development, within years of operation of the agreement, it was felt that the avowed intent of universally equitable and affordable access to health could be severely compromised unless concessions were made by amending the agreement.
In December 2005, the TRIPS pact was amended to incorporate specific safeguards to ensure that the public health concerns of affordability and accessibility for a large section of people in developing countries was not compromised. These amendments came into force only in January 2017, however, after two-thirds of the member countries ratified them.
Perhaps the most controversial issue surrounding TRIPS is its impact on the price and availability of new medicines. If patents are obtained and enforced in developing countries, TRIPS could reduce the availability of copies of patented medicines, thus adversely affecting a de facto price control on medicines in these countries. The manufacture of products that were unprotected by patents led to competition that played a key role in bringing down the prices for HIV antiretrovirals in Brazil, India, South Africa etc.
Accordingly, the price effects of implementing TRIPS should be monitored closely, both in countries with strong generic industries and those relying on imports of generic substitutes.
But there are other underlying structural impediments to access, beside price, such as the equity and efficiency of healthcare financing and drug/vaccine distribution systems, availability of evidence-based analysis to improve current practice and local community involvement.
An instructive and often-cited example of delivery failure is the uneven access to medicines on the World Health Organisation’s (WHO) list of essential drugs, of which less than 5% are on patent. To accurately measure access requires carefully considering the historical and social contexts of drug delivery.
Apart from the potential effects of patents on post-TRIPS pricing and availability, the comparative therapeutic benefits of new chemical entities over available generics will have health implications. So, in assessing TRIPS over time, the rate of pharmaceutical innovation will be a key variable in measuring the health impact of strengthened patent regimes.
Intellectual Property management skills will need to be developed so that TRIPS can be adapted to a nation’s advantage.
Developing countries that choose to invest in science and technology must, of necessity, address IP issues to participate in the international marketplace.
IP competencies will enable these countries to gain access to emerging tools, technologies and resources. Indeed, an acute need exists to establish policies and procedures and to train staff in effectively managing intellectual property.
Priorities include training in contract negotiation, statutory protection, patent searching and filing, technology valuation and business strategy development, as well as the development and implementation of IP policies and strategies at the institutional level, especially within public research institutions and universities. To provide the most useful and most accurate information, evaluations of the costs and benefits of TRIPS should consider investments in capacity building as an important variable.
The significant part of the current debate relating to TRIPs compliance by developing countries in general, and India in particular, has focused on the establishment of a product patent regime. It has been contended seriously on the one hand that a product patent regime would encourage innovation and foreign direct investment in a developing country, while on the other hand it would severely undermine the capability and growth of the domestic generic drug manufacturing industry. Such a regime would not only make public health more expensive, but also push it out of reach of the large sections of the poor in developing countries.
(The writer is with Lal Bahadur Shastri Institute of Management, New Delhi)