- Prelims: Cancer drugs, standing committee on health, WHO, CDK etc
- Mains GS Paper II: Science and technology- developments and their applications and effects in everyday life, biotechnology and issues related to IPR etc
ARTICLE HIGHLIGHTS
- The subject of the spiraling costs of cancer medicines and their implications have been highlighted in a recent report-Cancer Care Plan and Management, by the Rajya Sabha’s Standing Committee on Health.
INSIGHTS ON THE ISSUE
Context
Cancer
- It is one of the most dreaded diseases of human beings and is a major cause of death all over the globe.
- More than a million Indians suffer from cancer and a large number of them die from it annually.
- Mechanisms and development of cancer or oncogenic transformation of cells, its treatment and control have been some of the most intense areas of research in biology and medicine.
Cancer Care Plan and Management report:
- About 40% of cancer hospitalization cases are financed mainly through borrowings, sale of assets and contributions from friends and relatives”.
- Average out of pocket spending on cancer care is too high
- Spending for cancer care in private facilities is about three times that of public facilities.
- The Committee has highlighted the seriousness of problems concerning the treatment of cancer
- The estimated incidence in India was nearly 4(one point four) million in 2020.
Impact on survival rates:
- In breast cancer: The five-year survival rates in India and South Africa are 65% and 45%, respectively
- In high-income countries, it is nearly 90%.
- World Health Organization (WHO) report on pricing of cancer medicines and its impacts: The cost of a course of standard treatment for early stage HER2 (human epidermal growth factor receptor) positive breast cancer would be equivalent to about 10 years of average annual wages in India and South Africa and 7(one years in the United States.
- According to WHO: The costs associated with other medical care and interventions (such as surgical interventions and radiotherapy) and supportive care would make overall care more unaffordable.
Treatment protocol for breast cancer:
- CDK (cyclin-dependent kinase) inhibitors constitute a major therapeutic tool, especially for metastatic breast cancer.
- Drugs used:
- Ribociclib
- Palbociclib
- Abemaciclib
- They help in slowing the spread of cancer cells in the body.
- A month’s treatment using these drugs: ranges between ₹48,000 and ₹95,000.
Reason for high cost of cancer drugs:
- Argument advanced by the large pharmaceutical companies: They spend over $3 billion in bringing a new molecule to the market, which they must recoup in order to remain in the market for innovation.
- The WHO report: spending on research and development may bear little or no relationship to how pharmaceutical companies set cancer medicine prices.
- Profit: Companies set prices with an eye to maximize profits.
- Intellectual property protection: Pharma companies in the developed world have persuaded their governments to strengthen the rights that they derive from patents and other forms of intellectual property rights.
- They exercise monopoly control over their products.
Patent rights over the medicine:
- Patent rights over a medicine last until the expiry of its patent term after which generic competition leads to a reduction in its price.
- In the case of several non-communicable diseases, including cancer: Even before the generic producers enter the market, newer therapies could be introduced as standard care for treatment.
- In the case of pharmaceutical patents: Leading firms in the industry obtain patents on incremental innovations involving older medicines (“evergreening” of patents), extending their monopoly rights over the medicines.
Impact of patent rights on these drugs:
- The lack of access to these critical medicines.
- Financial crisis: Pushed the life of patients and their families into deep financial stress
- Article 21: It has a jeopardized right to live with dignity, a fundamental right guaranteed under Article 21.
Global stand on IPR:
- TRIPS Agreement: In 2001, Trade Ministers of WTO member countries endorsed the Declaration on TRIPS Agreement and Public Health that recognised the right of every country to grant CLs.
- Advanced countries had opposed the use of this instrument.
- Example:
- The United States: Trade administration’s annual review of the state of intellectual property protection and enforcement by the U.S.’s trading partners, namely, the Special 301 Report.
- European Union: It backed the use of CLs for increasing domestic production of COVID-19 vaccines and medicines by developing countries.
Compulsory Licensing:
- It allows governments to license third parties (that is, parties other than the patent holders) to produce and market a patented product or process without the consent of patent owners.
- Any time after three years from date of sealing of a patent, application for compulsory license can be made, provided:
- Reasonable requirements of the public have not been satisfied.
- Patented invention is not available to public at a reasonably affordable price
- Patented inventions are not carried out in India.
- Compulsory Licencing is regulated under the Indian Patent Act, 1970.
- The TRIPS Agreement does not specifically list the reasons that might be used to justify compulsory licensing.
- Doha Declaration on TRIPS and Public Health confirms that countries are free to determine the grounds for granting compulsory licenses, and to determine what constitutes a national emergency.
Evergreening:
- It is the practice of companies filing for an extension of a patent with minor process or product modifications just before the original patent expires at the end of 20 years.
Way Forward
- The three breast cancer medicines are currently under patent protection: Indian companies cannot manufacture these medicines without the consent of the right holders.
- Therefore, high prices on these medicines will continue at least until 2029, and possibly beyond, if these drugs are subjected to “evergreening”.
- The Supreme Court has interpreted right to life as the most precious human right:“ark of all other rights must be interpreted in a broad and expansive spirit so as to invest it with significance and vitality which may endure for years to come and enhance the dignity of the individual and the worth of the human person”.
- According to the WHO Constitution: “enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being”.
- Authorize Indian companies to domestically produce high-priced cancer medicines: By granting compulsory licenses (CLs) in keeping with Sections 84 and 92 of the Patents Act.
- The CLs override patent rights.
- Government can invoke provisions of Section 100: which empowers it to authorize any entity to use a patented invention without the authorisation of the patent holder.
- Section 100 can be useful if no domestic company shows interest in obtaining a CL.
QUESTION FOR PRACTICE
Q. How is the Government of India protecting traditional knowledge of medicine from patenting by pharmaceutical companies?(UPSC 2019) (200 WORDS, 10 MARKS)
