The issue of high-priced life saving drugs is a major concern in India. The issue has raised serious concerns from different sections of Indian society.
It was reported that on January 7, 2019, the Ministry of Health and Family Welfare took a concrete decision to bring rare disease drugs, ‘orphan drugs’, under compulsory licencing apart from price capping. Accordingly, the Department of Pharmaceuticals (DoP) was requested to look after the pricing aspect of those medicines. However, on the same day, the DoP expressed views contrary to those of the health ministry, exempting such medicine from price control, thus derailing the ministry’s plans to make the drugs affordable.
The matter, being serious, demanded solution on priority basis. The health ministry and the DoP are two sensitive arms of the government that had taken different stands on a serious issue, like right to life. The technicalities of the two wings favour their stand. While the health ministry is charged with safeguarding public health, the DoP is empowered with the pricing side of medicines.
It is equally ironical that the DoP had initially requested the ministry for identifying rare diseases so that it could cap prices on those drugs. The ministry was also under pressure as it was receiving many representations regarding exorbitant cost of life-saving drugs for rare diseases.
The health ministry discussed price capping and invoking compulsory licence for these ‘exorbitantly’ priced orphan drugs at a meeting on January 3, the day when DoP issued its order notifying changes to drug price regulation and removing price caps from several essential medicines, including patented and orphan drugs.
In this regard, the Department of Industrial Policy and Promotion (DIPP) was requested to make provision to bring those drugs under compulsory licencing.
The DoP’s stand contradicts with its earlier decision and seems to be at an intentional conflict with the ministry. In the meanwhile, the government has exempted innovative medicines produced by foreign companies from price control for five years.
Orphan drugs Orphan drugs are medicinal products intended for diagnosis, prevention, or treatment of life threatening or debilitating rare diseases. They are ‘orphans’ because the pharmaceutical industry has little interest in developing and marketing drugs intended for only a small number of patients suffering from very rare conditions. Orphan drugs are used to treat diseases that affect less number of individuals or for the diagnosis, prevention, or treatment of life-threatening, chronic, and seriously debilitating conditions. The development of such drugs comes with less incentives and profits.
Compulsory licenses Compulsory licenses are authorisations given to a third party by the government to make, use, or sell a particular product, or use a particular process which has been patented, without the need of the permission of the patent owner. The provisions regarding compulsory licenses are given in the Indian Patents Act, 1970 and in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement at the international level. Although this works against the patent holder, generally compulsory licenses are only considered in certain cases of national emergency and health crisis. There are certain pre-requisite conditions which need to be fulfilled if the government wants to grant a compulsory license in favour of someone.
The Department of Pharmaceuticals (DoP) was created on July 1, 2008 in the Ministry of Chemicals and Fertilisers with the objective to give greater focus and thrust to the development of the pharmaceutical sector and to regulate various complex issues related to pricing and availability of medicines at affordable prices, research and development, protection of intellectual property rights, and international commitments related to the pharmaceutical sector which required integration of work with other ministries.