The expanding universe of IP – OPINION – The Hindu
- Granting data exclusivity for clinical trials would undermine access to medicines
- April 26 is World Intellectual Property (IP) day (Prelims Stuff)
- Over the years, global IP standards have steadily expanded beyond World Trade Organisation (WTO) requirements
- Apart from increasing the scope of existing IP rights, there is a move to create new IP-like rights.
- A case in point is data exclusivity over clinical trial data submitted by drug companies to the regulatory authorities for market approval, the grant of which could severely undermine access to medicines.
- IP in the modern world defies definition, transcends boundaries and has become synonymous with ascribing value to things that we don’t fully understand
- Data exclusivity prevents drug regulators from referring to or relying on data submitted by an originator company relating to a drug’s safety and efficacy while approving bioequivalent versions of the same drug, i.e. therapeutically equivalent generics and biosimilars for a fixed period of time.
- drug that comes to the market for the first time undergoes extensive preclinical and clinical trials on animals initially and human beings later before it is introduced for public use — a time-consuming and expensive process. Developed countries, on behalf of their pharmaceutical lobbies, seek data exclusivity in developing countries arguing that this is necessary to recognise and incentivise the efforts put in to bring a new drug to the market along with recovering the research and development costs incurred — arguments similar to those used to justify the grant of patents.
- However, such exclusivity would prevent market entry of generic versions of the drug, which could be detrimental to the larger public interest.
- Pharmaceutical companies have been pushing for data exclusivity to prolong already existing monopoly and delay competition from generics even after the expiry of the 20-year patent term or to gain exclusivity on non-patented drugs.
- In India, such a system may negate the impact of Section 3(d) of the Patents Act, which disallows evergreening patents.
- With data exclusivity, a company could nevertheless gain exclusive rights over such drugs even though they are not patented. This is because during the period of exclusivity, regulators are barred from using the originators’ data to grant marketing approval to generics; generic companies would then be required to repeat the entire cycle of clinical trials already conducted instead of merely establishing bioequivalence to prove efficacy.
- As seen in countries where data exclusivity is granted, generic companies do not undertake such clinical trials and their versions of the drug accordingly stay off the market as long as the period of data exclusivity lasts. With restricted market entry of generics, artificially high drug prices remain which puts medicines beyond public reach. Apart from the financial costs, repeated clinical trials on human subjects raise ethical and moral concerns.
- Unlike in the West, India does not offer data exclusivity and allows bioequivalent generics to be registered based on, among other things, trial data available in the public domain.
- Test data as a public good
- Unlike automotive companies which use crash test dummies, pharmaceutical companies that test their drugs on human subjects have a greater obligation to make the data public and IP-free.
- The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) does not mandate data exclusivity. Providing data exclusivity is a TRIPS-plus measure
- According IP-like protection to data exclusivity is not advisable for three reasons
- First, it is an absolute protection granted without any institutional check such as opposition and revocation as available in other forms of IP and ends up as an irrevocable exclusivity to the originator.
- Second, the U.S. Supreme Court in Mayo v. Prometheus, 132 S. Ct. 1289 (2012) has excluded patent protection to biological correlations, terming it as an extension of natural laws. Extending IP-like protection to clinical observations — the primary objective of data exclusivity — will open a window to claim exclusivity in a subject matter traditionally excluded under patent law.
- Third, offering IP-like exclusivity solely on the basis of money spent in regulatory testing will set a bad precedent for other industries that may now claim an IP when there is none.
A call for reform – OPINION – The Hindu
- The IMF could turn irrelevant unless it reforms to keep up with rival global institutions
- Finance Minister Arun Jaitley has demanded reforms to the International Monetary Fund’s controversial quota system
- Quotas determine the size of contingency funds at the disposal of the IMF to lend to countries in need of help, as well as the power of individual countries to influence lending decisions and tap into the funds themselves.
- Though developing countries hold less than half the overall quota at the moment, with their rapidly increasing economic heft they have demanded a greater share — with limited success.
- . The 15th General Review of Quotas (GRQ), the most recent attempt to revise the size and composition of the system, was to be completed by October 2017, but the deadline has now been extended to 2019.
- IMF had doubled the overall size of the quotas to $659 billion (from $329 billion) while allotting an additional 6% of quotas to the developing world
- But with the rise of competing global institutions ready to meet the capital needs of the developing world, the patience of countries such as India may be tested more easily.
- The developing world is looking beyond the short-term crisis management tools that the IMF, as the sole international lender of last resort, has traditionally offered them for decades now — albeit in an unsatisfactory and politically biased way. China, for instance, with its steadily rising influence on the global economy, has grown to be the focal point for economies seeking alternative sources of capital to fund their long-term growth needs.
- India is seeking $2 billion from the New Development Bank, set up by the BRICS countries in 2015 with a more equitable power structure, to fund infrastructure projects.
- Asian Infrastructure Investment Bank, launched in 2014, could be an even bigger threat to the IMF’s influence given its larger membership, lending capacity and international reach
- In this environment of competition, the IMF will have to do more than just superficially tinker with its asymmetric power structure and outdated quota system. Else, it could be slowly but steadily pushed into irrelevance. Meanwhile, it remains to be seen whether India will continue to push for reforms at the IMF even as it simultaneously seeks to diversify its funding base, or whether it will assume a bolder stance in openly favouring one over the other.
On tribals and tigers – OPINION – The Hindu
- Despite helping in conservation, tribals are being denied rights in critical tiger habitats
- The National Tiger Conservation Authority (NTCA) recently ordered that there would be no tribal rights under the Scheduled Tribes and Other Traditional Forest Dwellers (Recognition of Forest Rights) Act, 2006 (FRA) in critical tiger habitats.
- This direction is not only bad in law, but is also symptomatic of defective conservation practices that India has clung to since colonial times.
- Both the ‘Guidance document for preparation of tiger conservation plan’ and the ‘Protocol/guidelines for voluntary village relocation in notified core/critical tiger habitats of tiger reserves’ issued by the Environment Ministry acknowledge that although there is a need to keep forest reserves as inviolate for the purposes of tiger conservation, this ought to be done without affecting the rights of traditional forest dwellers.
- The NTCA and the relevant expert committee constituted to ensure tiger conservation under the Wildlife Protection Act, 1972 (WPA) have a mandate to ensure conservation along with human coexistence.
- Compromises on the rights of tribals can be made only where there is proof that the tribal/right holder’s presence in these protected areas will create irreversible damage to their ecology
- Neither the FRA nor the WPA has ever made a case for circumscribing the rights of tribals in the name of environmental protection.
- Even in the face of significant evidence that tribals have helped in increasing the tiger population, whether the Soligas in the BRT Tiger reserve in Karnataka or the Baigas in the Kanha National Park in M.P., they have been periodically evicted, even as corporations and developmental projects are given a free hand to generate an environmental crisis on an unprecedented scale.
- According to the Global Environmental Justice Atlas data of 2016, India registered the highest number of environment-related conflicts (222) in proportion to the population.
- It is thus necessary for civil society and peoples’ collectives to forge an alliance to prevent dissociating indigenous communities from the environmental conservation narrative. Strengthening the FRA and eliminating instances that marginalise people in the name of conservation will require greater policy attention.