New Delhi: For the first time ever, a consensus has evolved on creating global patent databases, monitoring drug prices and encouraging companies to differentially price their drugs, as a burgeoning health care bill pushes governments towards sourcing cheaper medicines.
Cheaper drugs? Dr Reddy’s pharmaceutical plant in Hyderabad.
The initiative, part of a draft agreement adopted by all the countries in the World Health Assembly in Geneva recently, has been cheered by public health advocates and makers of generic or off-patent drugs. The assembly is an apex group of member nations at the World Health Organization or WHO.
Even though the draft is not binding on all nations, sector experts say it is a conceptual breakthrough as it has set a common ground for action and vindicated public health measures supported by developing countries such as India.
“All the member nations of WHO have endorsed this position. It is a big victory for public health activists and the Indian government," said a senior official at the Union ministry of health and family welfare who was closely associated with the negotiations in Geneva. While “the draft doesn't have the force of law”, added the official, it is significant on grounds of “moral suasion”. These provisions were objected to by the US but finally found their way into the consensus draft, signifying a softened stance by one of the strongest champions of patents and intellectual property, which have come in the way of widespread adoption of generic drugs.
The draft notes the need for “compiling, maintaining and updating user-friendly global databases which contain public information on the administrative status of health-related patents” and strengthening “national capacities for analysis of the information” in these databases.
The Indian government wanted WHO to be the lead agency in developing such a centralized database, said the ministry official, but that was not agreed to by other nations that are proposing that other agencies such as the World Trade Organization or the World Intellectual Property Organization play that role.
Such an information tank, said Indian Pharmaceutical Alliance’s secretary general D.G. Shah, would aid governments and drug procurement bodies such as Médecins Sans Frontières in identifying if the drugs are patent protected in a certain country or not.
Although multinational drug makers, who typically invest billions of dollars in research and development, only secure patents in 50-60 countries, once a drug is known to be patented, the belief goes around that it is so worldwide, giving companies “de-facto patent protection even in countries where they have not incurred the patent filing expenses”, he said. “A database will lift the veil on such cases.” The Indian Pharmaceutical Alliance is a trade lobby representing Indian generic drug makers.
The health assembly has, in its draft, also asked member nations to “encourage pharmaceutical companies and other health-related industries to consider policies, including differential pricing” to promote availability of affordable drugs and consider “development of policies to monitor (drug) pricing”. Differential pricing is a practice used by patent-holding drug makers to sell their new, expensive drugs at a price that is affordable to needy patients.
Novartis India Ltd's managing director Ranjit Shahani, who was the president of Organisation of Pharmaceutical Producers of India, a lobby of foreign-owned drug makers in India, called differential pricing “directionally positive” and ones that recognize people's varying paying capacity, though the implementation should be through a workable model.
Merck Inc.‘s MSD Pharmaceuticals Pvt Ltd. has already introduced its diabetes drug Januvia in India at a fifth of its US prices while GlaxoSmithKline Plc. is also in the process of introducing cancer drug, Tykerb at a discount in India. Others could follow.
The clause for “drug monitoring” has failed to impress the drug access campaigners. “Monitoring prices is a good step but controlling prices would have been a better and stronger one,” said Kajal Bharadwaj, a lawyer specializing in drug access-related patent issues and added that the health assembly text “legitimizes and validates the public health hedges in government policies that countries like India, Thailand and Brazil have been sticking up for”.