Syllabus: GS2/ Health
Context
- A growing number of rare disease patients in India are urging the government to invoke the compulsory licensing provision under the Indian Patents Act, 1970.
About
- Compulsory licensing is a legal tool under Section 84 of the Indian Patents Act, 1970, which allows the government or any third party to manufacture a patented product or use a patented process without the consent of the patent owner in certain conditions.
- It aims to protect public health and access to affordable medicines.
- A compulsory license in India can be granted three years after a patent is issued if:
- The patented invention is not available to the public at a reasonable price.
- The reasonable requirements of the public are not being satisfied.
- The invention is not being worked on in the territory of India.
Legal Policy Landscape
- Patent Law Amendments: India’s 1970 Patents Act originally allowed only process patents, enabling generic drug manufacturing.
- Hence, India became the “pharmacy of the world” by producing affordable medicines.
- Safeguards Against Monopoly Abuse: India’s law includes anti-evergreening provisions (Section 3(d)) to prevent companies from extending monopoly through minor modifications.
- It also allows for pre- and post-grant opposition to patents.
TRIPS Agreement and Flexibilities
- India became a member of the World Trade Organization (WTO) and was required to align its intellectual property laws with the TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights), which came into effect in 1995.
- The TRIPS Agreement provides for the compulsory licensing (CL).
- India amended its Patents Act in 2005, allowing for both product and process patents in the pharmaceutical sector.
- These patents are now valid for a period of 20 years from the date of filing.
- The Doha Declaration on TRIPS and Public Health (2001) further clarified that:
- Countries may issue a compulsory license in the interest of public health emergencies, although the presence of an emergency is not a mandatory condition.
- Each country has the sovereign right to determine the grounds on which it can issue a compulsory license.
- The patent holder must be compensated through the payment of “adequate remuneration,” the amount of which is to be determined by the issuing country based on the economic value of the license.
- A waiver in 2003, later made permanent in 2017, allowed countries to import affordable drugs produced under CL from other nations.
- This created a legal route for cross-border access to affordable medicines.
| What are Rare Diseases? – Rare diseases, also known as orphan diseases, are conditions that occur infrequently within a population. 1. They are characterized by three key markers: Total number of people with the disease, Prevalence and Availability /Non-availability of treatment options. – The World Health Organization (WHO) defines a rare disease as a condition that affects a small percentage of the population, typically fewer than 1 in 1,000 to 2,000 people. Initiatives taken for rare diseases in India – National Policy for Rare Diseases (NPRD), 2021: It was launched in 2021, under which financial assistance up to Rs 50 lakh is provided to patients receiving treatment at an identified Centre of Excellence (CoE). – The Health Ministry has opened a Digital Portal for Crowdfunding & Voluntary Donations with information about patients and their rare diseases. 1. Donors can choose the CoE and patient treatments they wish to support. – Each Centre of Excellence (CoE) also has its own Rare Disease Fund, which is used with approval from its governing authority. – The Department of Pharmaceuticals has launched the Production Linked Incentive (PLI) Scheme for Pharmaceuticals, offering financial incentives to selected manufacturers for domestic production of orphan drugs. |
Source: IE
Previous article
Brahmaputra Flow in India and Impact of Chinese Dams
Next article
India-Türkiye Relations