Using TRIPS flexibilities to safeguard Indian healthcare

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Introduction

The pandemic has highlighted the fact that India has become the most important of the nations in contemporary times because it is a very diverse country[1] with an enormous consumer base and in these testing, times has shown great moral fiber along with the great potential to overcome any problem[2]. Intellectual property has now become a very important subject in India because it is through the planning of the mind that a nation progresses.

The article tries to analyze how the flexibilities offered by WTO[3]’s TRIPS can be used as a safeguard to protect the domestic healthcare sector.

TRIPS agreement introduced that there has to be a minimum standard of protection that would have to be provided by member states to other member states’ IP[4][5]. Now this particular aspect of the agreement makes the developing and the underdeveloped countries vulnerable to underperformance and unfulfillment of their national goals but the various flexibilities that have also been incorporated in this agreement can be used to effectively counter this disadvantage and therefore it is of utmost important to explore the area

The problem

The Covid-19 pandemic has highlighted the stark reality that exists in our healthcare sector such as the lack of infrastructure, lack of skilled work fraternity and high costs of treatment. It is although remarkable that India has made some significant changes in the healthcare sector such as Universal Immunization projects and the Ayushman Bharat but the changing trend in the healthcare sector due to technology advancement still poses a complex challenge for the sector.

Technology has drastically changed the course of the healthcare sector such as advanced treatment for deadly diseases, and preventive medicines and has improved living standards but in this modern area where intellectual property rights are given utmost importance and the healthcare sector has become commercial, it has become a costly affair which is mostly out of the reach of a common middle-class man[6].

Despite receiving at least US$70.5 million in government funding to develop remdesivir, one of the candidate drugs for COVID-19 treatment, Gilead had signed secretive bilateral agreements with a few generic companies of its choosing that exclude nearly half of the world’s population from its licensed territories.[7] As a result, it is becoming extremely difficult for the domestic industry to flourish and provide healthcare services at an affordable and reasonable rate.

TRIPS and its flexibilities in the Indian healthcare sector

Intellectual property rights are generally defined as the rights given to the creator for the creation of the mind[8] and it is this right that encourages research and development to create new products and services which in return helps our society to progress. With regard to the healthcare sector, IPR has a special place because of the fact that a great amount of time and wealth is put into discovering and designing path-breaking technologies to create effective medicines, to create more sophisticated treatment methods, and all.

The most important of the IPRs are the patents that are in place to protect and encourage innovation and new ideas[9]. The TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement of the World Trade organisation is the one that introduced and regulates Intellectual Property rights in multilateral trading systems[10].

The problem with TRIPS

The objective of this agreement is to promote innovation and grant protection to individuals and organisations for the product or services that they create but the agreement’s mandate which requires all the member states to have a minimum level of IP protection for other member states seems to have a far-reaching negative consequence for most of the developing and underdeveloped states. . It is worthy to note that giving just recognition to inventors and researchers is not enough but there needs to be some form of financial aspect that acts as a fuel to encourage other people to get involved in that field and work to achieve a breakthrough.

Affluent societies are understandably spending an enormous amount of money on the search for new products to enhance and prolong life[11] but this makes the service or the product expensive. In Covid-19 it is, therefore, necessary more than ever to have flexible provisions in laws and rules regarding Intellectual property rights and it was therefore why India along with South Africa made a proposal in 2020 for WTO waiver of IPRs.[12] Apart from this, the major disadvantage regarding the minimum standard provision is that it tends to drive research toward a common disease that already has a cure hence it does not help in the national development of a developing country.[13]

Flexibilities of the TRIPS agreement

The TRIPS agreement cannot be critised absolutely because there are few clauses that provide flexibilities in IPRs and try to strike a balance between public welfare and protection of intellectual rights and it was through the Doha declaration that these flexibilities got genuine weight and meaning.

  • TRIPS Article 7 aims to strike a balance between innovation and social and economic well-being.
  • Article 8 gives the states the right to take necessary actions to promote public health.
  • Article 27(2) gives the right to states to restrict patentability if it is a threat to life.
  • Article 31 has all the provisions where a member state can use the product without prior approval of the patent holder.

Why India needs to use these flexibilities

The healthcare sector is the largest sector in terms of revenue and employment, at a CAGR of 39 percent, the Indian healthcare market is predicted to reach $190 billion by 2020 and $372 billion by 2022.[14] Therefore it is really imperative for India to step up its game and work towards protecting its domestic healthcare sector. The main aim should be to provide these essential services at an affordable rate to almost all the citizens of the country and that these services are advanced and world-class. The effective use of these clauses can help develop the industry and drive research and development to make India a leader in healthcare services.

Suggestions and Recommendations

Indira Gandhi in her speech at the World Health Assembly in 1980 inspiringly quoted that our world should be free from rules and rights which allow individuals to make profits in matters of life and death and that medical inventions will be free from patents. In Bayer Corpn. v. Union of India[15] it was effectively showcased that countries like India can use TRIPS flexibility to achieve the constitutional right of health and at the same time also safeguard individual intellectual rights.

Here are some of the suggestions and recommendations that the research paper wishes to put forward :

  • There should be some provisions to facilitate parallel import of certain lifesaving drugs.
  • Proposals like the one put forward India and South Africa for WTO’s waiver on COVID-19 medical technologies should be accepted by the world to provide all the countries atleast for the duration of the pandemic the intellectual knowledge to fight it.
  • There can be effective laws that can be made to use the drug by government procurement and made it accessible for all
  • One of the flexibility is the right to limit the patentability therefore several high-level committees should be formed to decide if that product needs a patent or not.
  • Patents for essential medicines should be not for unreasonable amount of time[16] .
  • An environment of research and development should be made to facilitate more innovation and inventions
  • People should be made aware about the process of patenting and they in general should be informed about the variours IPRs through awareness campaigns.
  • Time and again audits should be done to find out any anti-competitive practice by international companies and make a legistaion to penalize those practices (generally in the healthcare sector).

Conclusion

Countries should make use of the TRIPS flexibilities to safeguard public health and achieve their national goals and therefore its imperative for a large country like India to use them effectively to achieve development. The issue regarding IPRs and the safeguarding of domestic healthcare sector has become a matter of discussion because of this unprecedented pandemic that has changed the global scenario. It is important for all the stakeholder to come together and frame guidelines to utilize this provision to the fullest.

 

Bibliography:

  • Council on Foreign Relations
  • Sreeram Chaulia,Why the world is standing with India, Mint (11th May 2021, 6:25 PM),
  • Advice on Flexibilities under the TRIPS Agreement, WIPO
  • TRIPS — Trade-Related Aspects of Intellectual Property Rights, World Trade Organisation
  • Akshay Anurag, Pharmaceutical Patents And Healthcare: A Legal Conundrum, The SCC Online Blog ( 28th August 2021, 9: 45 PM)
  • India and South Africa proposal for WTO waiver from intellectual property protections for COVID-19
  • Related medical technologies Briefing Document, Access Campaign
  • What are intellectual property rights? , World Trade Organisation
  • Working towards building a healthier India, Invest India
  • Bayer Corpn. v. Union of India, 2014 SCC OnLine Bom 963

 

References:

[1]Council on Foreign Relations, (28th August 2021 , 8:55 PM), https://www.cfr.org/project/indias-roleworld#:~:text=On%20the%20one%20hand%2C%20India,to%20promote%20these%20values%20abroad.

[2] Sreeram Chaulia, Why the world is standing with India, Mint (11th May 2021, 6:25 PM),https://www.livemint.com/opinion/online-views/why-the-world-is-standing-with-india-11620674874059.html

[3] World Trade Organisation

[4] Intellectual Property

[5] Advice on Flexibilities under the TRIPS Agreement, WIPO, (28th August 2021, 9:21 PM ), https://www.wipo.int/ip-development/en/policy_legislative_assistance/advice_trips.html.

[6] Akshay Anurag, Pharmaceutical Patents And Healthcare: A Legal Conundrum, The SCC Online Blog ( 28th August 2021, 9: 45 PM) https://www.scconline.com/blog/post/2019/09/03/pharmaceutical-patents-and-healthcare-a-legal-conundrum/.

[7] India and South Africa proposal for WTO waiver from intellectual property protections for COVID-19

Related medical technologies Briefing Document, Access Campaign (28th August 2021, 10:00 PM).

[8]What are intellectual property rights? , World Trade Organisation (August 29th 2021 , 4:00 PM) https://www.wto.org/english/tratop_e/trips_e/intel1_e.htm.

[9] Id. Para 2.

[10] World Trade Organisation, supra note 6.

[11] Anurag , supra  note 8.

[12] Access Campaign, supra note 9.

[13] Anurag , supra  note 8.

[14] Working towards building a healthier India, Invest India,(29th August 2021, 4:15 PM ), https://www.investindia.gov.in/sector/healthcare.

[15] Bayer Corpn. v. Union of India, 2014 SCC OnLine Bom 963.

[16] Anurag , supra  note 8.


This article has been authored by Rushaan Raana Samuel, a student at GITAM School of Law, Gitam (Deemed to be) University, Visakhapatnam.

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