According to World Health Organisation about 10 million people lose their lives each year due to lack of access to medicines and vaccines. Most of these deaths happen to be in the low and middle-income countries like Pakistan. Therefore, access to medicines is a grave concern for these countries, who in return look up to WHO for assistance in this regard.
Access to medicines and vaccines are imperative to achieve both curative and preventive care in a health system. There are various factors which deter this access to medicines and vaccines such as poor infrastructure, limited supply, poor health spending by the government and high prices. Major cause of high prices is the result of Intellectual Property Rights (IPR) that are conferred upon the World Trade Organization (WTO) member states through the Trade Related Intellectual Property Rights (TRIPs) Agreement, signed in 1994.
The concept of Intellectual Property Rights is grounded upon the principle that the person who makes an intellectual contribution must have an exclusive right to enjoy the bounties of his hard work so as to promote further research and development. It may sound legit, but the problem arises when the premium afforded to pharmaceuticals comes at the cost of an entire nation’s health.
There is a need to provide safeguards to ensure that this exclusive right of the patent holder is not misused as these exorbitant prices for patented life-saving drugs jeopardise the lives of millions in developing and underdeveloped countries. Medical knowledge with its financial and commercial aspect cannot be regarded as a pure public good, at the same time access and dissemination of this knowledge remains imperative for the well-being of societies. Ideally, medical knowledge should be regarded as a pure public good particularly in regards to production and access to life saving drugs thus giving precedence to health and life over patent rights.
In 1996, WHO published a guide with set of recommendations for member states to implement TRIPs by neglecting its negative aspects to safeguard drug availability. These recommendations were not sufficient in relieving member states from IPR. In 2001 Doha declaration took place which urged WTO member states to exercise the right to grant compulsory licenses by assessing the need of their people and grant license in emergency situations to counter the negative effects imposed by TRIPs. Compulsory licensing allows a government to issue a license to a company or a government agency; the right to use a patent without the consent of the patent holder. The objective of granting compulsory licenses is to safeguard public health.
Now, that countries have been given the edge to prioritise their nations health over IP rights, many countries have not been able to benefit from this leverage. Pakistan happens to be one of those countries which haven’t been able to take advantage despite of the poor health statistics of the nation, whereas Pakistan’s neighbouring country India has taken a bold step against the monopoly of big pharmaceutical companies.
In 2012, India issued its first-ever compulsory license to its local pharmaceutical company Natco Pharma Ltd to produce life extending drug called ‘Sorafenib’ for kidney and liver cancer. This compulsory license was granted against a patent for ‘Bayer pharma’ a Pharmaceutical company in U.S. There was a lot of pressure exerted on India by US and pharmaceutical companies of other developed countries however; the license was issued on the grounds that the requirement of the public have not been fulfilled by the patent. Price of the drug went down from Rs 280,420 to Rs 8800/- .
In 2013, India again took an unflinching step against Swiss drug maker Novartis by denying a patent for its cancer drug Glivec. Despite of all the pressure and heavy lobbying from the developed world, the Indian Supreme Court denied the patent on the grounds that there was only an incremental improvement over the existing version. In the past, the practice of big pharma companies to tweak an existing drug formulation to extend the life of its patent, in effect seeking a secondary patent, is well documented.
There was a global reaction in response to India’s bold decision against IP rights. Since then India has openly been criticized by pharmaceutical companies and first world countries for hampering research and development in the field of medicine. However, it is commendable to note that India did not give heed to these accusations and criticism but in fact kept the health of its people above all other pressures.
In Pakistan recently, a judge stopped a local pharmaceutical company from manufacturing a cheaper version of a drug because a multinational produced a certificate issued by the copyright office stating that the lab test documents for that drug were copyright. Now, if that copyright is accepted, among other things, Patents Act, and the Copyright Act has got nothing to do with this situation. In this case, there was no legal way with the multinational to prevent the cheaper version of the drug from being manufactured by the local industry using the patent law but since there are hardly any IPR experts in Pakistan the local pharma was denied the compulsory license.
WHO has played a significant role as an instrument for making recommendations however, it has not exercised its law making powers that are conferred upon it in its constitution. Due to this reason it may be argued that despite of passing multiple resolutions and publishing various guide lines for making access to cheap medicines available, WHO has not been able to achieve its goal.
Therefore, developing countries like Pakistan will have to take gallant steps on its own like India. The government of Pakistan needs to take necessary steps to improve the pharmaceutical infrastructure. It needs to encourage and promote development of indigenous basic drug manufacturing expertise and make sure that local pharmaceuticals are producing drugs whose patents have run out to lower the prices of drugs. Moreover, there is dire need to develop the culture of research and development in the pharmaceutical industry and inculcate the values of research in our coming generations.