Syllabus: GS3/Science and Technology
Context
- The Indian government is considering implementing “data exclusivity” in the pharmaceutical drugs sector.
- The government’s approach appears to be driven by the expectation that the provision could help bring in additional investment in the country.
Patent in Pharmaceutical Industry
- In the pharmaceutical industry, patents are broadly classified based on what aspect of a drug or process is being protected.
- Pharma patents protect drug molecules, processes, formulations, uses, and delivery systems.
- Types of Patents in India are: Product Patent, Process Patent, Improvement Patent and Biotechnology Patent.
- Criteria: An invention must satisfy:
- Novelty i.e. it is new worldwide.
- Inventive Step: An invention must not be an obvious modification or simple combination of existing knowledge.
- Industrial Applicability: It is capable of being made or used in industry.
- Term of Patent: 20 years from date of filing which is compliant to TRIPS.
- Compulsory Licensing (CL): Compulsory licensing is when a government allows someone else to produce a patented product or process without the consent of the patent owner. It is allowed under Section 84 of Patents Act, 1970 when:
- Reasonable public requirements not met.
- Drugs are not affordable.
- The patented invention isn’t worked (manufactured/exploited) in India.
- There is an international filing system known as Patent Cooperation Treaty (PCT) system.
- When a PCT application is filed, an inventor of a member country of PCT can simultaneously obtain priority for his/her invention in all the PCT member countries.
- India joined PCT in 1998.
- All activities related to PCT are coordinated by the World Intellectual Property Organization (WIPO) situated in Geneva.
| Trade-Related Aspects of Intellectual Property Rights (TRIPS) – TRIPS is a binding WTO agreement that sets minimum global standards for the protection and enforcement of Intellectual Property Rights (IPRs). – It has been in force since 1995. – It is binding on all WTO members, including India. World Intellectual Property Organization (WIPO) – It is a self-funding agency of the United Nations, that serves the world’s innovators and creators, ensuring that their ideas travel safely to the market and improve lives everywhere. – History: WIPO was established in 1967 by the WIPO Convention. – Members: The organization has 194 member states including both developing and developed nations like India, Italy, Israel, Austria, Bhutan, Brazil, China, Cuba, Egypt, Pakistan, the U.S. and the U.K. a. India joined WIPO in 1975. – Headquarters: Geneva, Switzerland. |
Data Exclusivity
- In the Absence of Data Exclusivity: When a company develops a new drug, it must submit clinical trial data demonstrating the safety and efficacy of its product to regulators.
- The regulator may use this data to approve another company’s generic version on the basis of much less resource-intensive bio-equivalence studies.
- The generic manufacturer can then start marketing its generic drugs on the date the original company’s patent ends.
- Data exclusivity is not implemented in India’s regulatory system to prioritize affordable medicine access over originator data protection.
- India’s approach has enabled the country to develop the world’s largest generic pharmaceutical sector.
- Data Exclusivity: This provision grants innovator pharmaceutical companies exclusive rights over the clinical trial data, meaning a regulator cannot use it to grant approvals to generic versions.
- So, generic drug companies have to either wait until the exclusivity expires or carry out expensive clinical trials themselves to prove safety and efficacy.
Significance of Data Exclusivity
- Incentive for Innovation: Data exclusivity in India can protect the costly and risky clinical trial investments which eventually encourages new drug discovery and R&D.
- Attracts Foreign Investment: By providing predictable regulatory protection, India might be seen as an IP-secure destination and will attract a large amount of FDI in the Pharma sector.
- Boost to Original Research: It encourages Indian firms to move from reverse engineering to innovative drug development.
- Alignment with Global Practices: Countries and groupings like USA, EU, Japan provide data exclusivity, India can also become a part of the nations protecting rights of the original innovator.
Concerns with Data Exclusivity
- Delay in Generic Drug Entry: It will block approval of generics creating a de facto monopoly beyond patent term.
- Harms Domestic Generic Industry: If India were to agree to data exclusivity provisions, its generics-focused pharmaceutical industry may lose its edge in international markets.
- Almost 90% of Indian pharmaceutical companies manufacture generic drugs, they do not invest in developing new ones.
- Increases Cost of Medicines: This will also delay access to cheaper medicines to the people of the country.
- Ethical Issues in Clinical Trials: It can lead to Pharma companies conducting questionable, unnecessary clinical trials to get incentives.
- Impact on Healthcare System: It will lead to the lower availability of affordable medicines which will increase burden on public health systems in India.
- Impact on Global Health: India is the pharmacy of the world, exporting cheap generic drugs all over the world. Data Exclusivity will impact the supply of affordable drugs to Africa, Asia, Latin America.
Way Ahead
- While data exclusivity can incentivise innovation and investment, in India it risks delaying generic competition, raising drug prices, and undermining public health.
- India’s cautious rejection of data exclusivity reflects a conscious choice to prioritise affordable access to medicines while using TRIPS flexibilities wisely.
Source: IE
