Ranjit Shahani, President of the Organization of Pharmaceutical Producers of India released the following statement on Intellectual Property Day concerning the effect drug patent protection is having on innovation in India:
Emotion tends to override facts when it comes to patents and patients’ concerns. Consider the fears stoked when India joined the World Trade Organization in 1995. Many feared drug prices could rise, access to medicines could be reduced and many Indian pharmaceutical companies could close down.
Fifteen years later, these fears have proved unfounded: Drugs in each category are available at multiple price points, accessibility is clearly independent of patents, and Indian companies have become multinationals and enter[ed] foreign markets worldwide.
When India reinstated patent protection via IPR (intellectual property rights) reforms, many feared this would lead to decreased access to medicine and delayed entry of generic medicines. Despite the lack of pharmaceutical patents in India for 35 years and some of the lowest prices for medicine in the world, access to medicine in India remained among the lowest in developing nations. In other words, patents have little to do with the ability to access medicines.
While many try to point fingers at drug patents and IPR protection, the lack of healthcare financing and particularly health insurance are the real culprit[s]. Limiting the types of innovations which receive patent protection, as India currently does, won’t improve the health of Indians.
Small innovations that build on existing knowledge are the true backbone and a specific strength of the pharma industry. Yet, Indian laws prohibit certain types of pharmaceutical innovations from patent protection, thereby discouraging research. Indeed, this policy hurts Indian patients the most.
There are many meaningful benefits of continued research on existing medicines. For instance, drug formulations and delivery systems can be optimised for greater effectiveness in India’s hot, humid climate. Paediatric formulations could be developed for babies suffering from diseases more often found in adults. It could also promote the development of treatment for diseases prevalent in India — tuberculosis, malaria, filariasis and other tropical diseases — where breakthroughs are unfortunately rare.
Innovation, research and patent protection are critical to introducing new drugs into the market. Innovations and effective drugs are inseparable, as diseases constantly mutate and many have inadequate treatments
Without patent protection, innovations decline, as R&D needs immense investments. Due to high, ever-increasing R&D costs, only two in 10 approved medicines earn more than the average cost of developing a new drug. Statistics are telling: a new drug discovery cost around $138 million in 1975, $318 million in 1987 and more than $1.3 billion in 2006.
The Prime Minister, Dr Manmohan Singh, has acknowledged the critical role of innovation at the 97th Indian Science Congress held in Thiruvananthapuram recently: “Our Government has declared 2010-20 as the ‘Decade of Innovations’. We need new solutions in many areas… in healthcare, in energy, in urban infrastructure, in water management, in transportation… The country must develop an Innovation Eco-system to stimulate innovations… And innovative solutions with potential must be nurtured and rapidly applied.”
As we take a look at drug patents on Intellectual Property Day, we must not forget the important role they play in keeping India and the world healthy. With viruses that mutate constantly — HIV/AIDS, H1N1, and TB — incremental innovations are imperative to stay one step ahead in the war against disease. If all innovations are protected to expand treatment options, millions of patients in India and worldwide will benefit. At stake are not just patents, but the lives of millions.
Filed under: Asia, Commentary on news & events, Innovation, intellectual property | Tagged: access to medicines, drug pricing, incremental innovation, India, Innovation, intellectual property, World Intellectual Property Association | Leave a Comment »
NICE to lose powers to reject new drugs
The British government is expected to strip the National Institute for Health and Clinical Excellence, or NICE, of its ability to reject new drugs.
Currently, NICE “scrutinizes the cost and clinical benefits of new drugs to determine whether the state health-care system should pay for them,” The Wall Street Journal reports. “If NICE decides that a drug isn’t worth its price tag, it advises doctors not to prescribe it, which effectively results in a ban. But Britain’s new coalition government, led by the Conservative party, is planning to strip NICE of the ability to reject drugs, the Department of Health said in a written response to questions Monday. Conservative Party leaders are both trying to limit the size and reach of government and put power in the hands of doctors, rather than administrators, when it comes to treatment decisions. In the future, NICE will advise doctors on the best approaches to treating various diseases” and decisions about payment for new treatments ”will be made through ‘a new system of value-based pricing,’ the statement said” (Whalen, 11/2).
Nature.com: In value-based pricing (VBP), “fees are negotiated with companies on the basis of a scientific assessment of the drug’s clinical value. Countries such as Canada and Australia already use versions of VBP, but Britain has an enormous influence on the rest of the world, says Karl Claxton, a health economist at the University of York, UK. Other countries, for instance, use NICE guidance to help make healthcare decisions. … Some though have already warned of adverse consequences if industry does not feel the prices offered adequately reward the development of new drugs” (Cressey, 11/1).
Courtesy of Kaiser Health News’ Daily Report.
Filed under: Commentary on news & events | Tagged: access to medicines, drug pricing, National nstitute for Health and Clinical Excellence, NICE, Public health, UK | Leave a Comment »