LEGAL PERSPECTIVES TOWARD DRUG PATENT BASED ON TRIPS SAFEGUARDS IN THE MIDST OF COVID-19 URGENCY

Oleh :

Moh. Rifli Mubarak

INTRODUCTION

If we look deeper into intellectual property, it contains a dichotomous interpretation both in terms of protecting the creation and in terms of its exclusivity. If this is correlated with the current pandemic situations, it is closely related to the patent registration process of various pharmaceutical companies in various parts of the world to create a drug for COVID-19 that can be used in accessible way by the public although this presents pros and cons regarding patent registration.

It is such a dilemma that can be viewed in terms of drug patent registration for COVID-19 which is often judged to have an element regarding the exclusivity of pharmaceutical company patents with its own complexity, or in terms of prioritizing accessibility related to drug distribution in the context of efforts to heal people throughout the world. In Indonesia itself, this is a form of legal issue that needs to be correlated with the harmonization of the substance between Law No. 13 of 2016 concerning Patents and the substance contained in the Agreement of Related Aspects of Intellectual Property Rights (TRIPS), especially in the context of safeguards.

Salus populi suprime lex esto which means “people’s safety is the highest law” becomes an affirmative adage to us that in the present moment, what are our priorities in responding to this pandemic even though it must pass through a dilemma which is becoming a separate issue in the realm of the pharmaceutical industry and in terms of positive law in Indonesia and international law. If examined further, the exclusivity in question is also interpreted as an appropriate form of protection for the drug patent so that it is considered as a form of appreciation to researchers who have spent a lot of investment and time to carry out the development and trial.

Thus, there are still many perspectives that open our point of view regarding the essence of the determination of patents in the pharmaceutical industry in the midst of current urgency that must be reviewed comprehensively from various sides. The growth of the global pharmaceutical industry is predicted to increase 1% -3% in the next 12-18

months. This figure is still lower than the previous prediction due to uncertainties toward the condition of the COVID-19 outbreak which affected the impact on the distribution and accessibility of medicines in an inclusive manner.1This was revealed in the results of research conducted by Moody’s Investor Service.Inc which was released on May 19, 2020. COVID-19 has caused a disruption of the health system which has a negative impact on industrial utilization.

So, the impact of this pandemic concretely is not only related to the production controversy over COVID-19 drugs, but also has a variety of impacts. For example, this pandemic has slowed clinical trials of a number of therapeutic drugs that are in process, causing delays in marketing new drugs. In addition, problems related to financial aspects are also in a critical phase such as licensing uncertainty, price uncertainty, to business competition. The problem is certainly trying to threaten Indonesia’s health system that is characterized by regional striking and social inequalities.2

Sometimes we also question, how the government’s efforts in designing constructive strategies in the health sector in order to answer the current challenges. Bloom, Canning and Sevilla (2003) have suggested that a one-year improvement in a population’s life expectancy contributes to an increase of four percent in output and economic growth.3In that sense, the problem of being able to improve our health system in the midst of the current situation is a joint issue, especially in the production of patent medicines that are needed by the community and this is correlated to improving life expectancy. The basic regulation of this topic is Law No. 13 of 2016 concerning Patents, which are the basis of national law in Indonesia, will then be harmonized with the TRIPS Agreement as a form of harmonization related to the analysis of legal issues concerning patents in the pharmaceutical industry.

1Nindya Aldila, “COVID-19 Picu Ketidakpastian Bagi Industri Farmasi Global”, (Bisnis.com, 21 May 2020) <https://ekonomi.bisnis.com/read/20200521/257/1243443/covid-19-picu-ketidakpastian-bagi-industri farmasi-global> accessed on 5 July 2020

2United Nations Conference on Trade and Development, “Development Dimensions of Intellectual Property in Indonesia:Access to Medicines, Transfer of Technology and Competition” (New York and Geneva: UNCTAD, 2011), 35

3Richard Husada and Raymond R Tjandrawinata, The Healthcare System and the Pharmaceutical Industry in Indonesia. (U.K: Palgrave Macmilan, 2013), 10.

ANALYSIS

Indonesia’s efforts in the field of patents, have been fundamentally outlined in Law No. 13 of 2016 concerning Patents which is a substitute for Law No. 14 of 2001. The replacement of this law is a form of substantial adaptation to the development of law at the national and international level which essentially accommodates international trade agreements issued by the World Trade Organization (WTO) in the Agreement on Trade-Related Aspects of Intellectual Property Rights.

Patents are basically a “barrier to entries” in the pharmaceutical industry. With patents, companies can limit the space for other companies to innovate, because they have to wait for a drug license that is categorized as having a patent that has been completed or is called an off-patent and of course this takes a long time. Therefore, it is very important for the national pharmaceutical industry to have a continuity in innovating by prioritizing the discovery of new drug products at more affordable prices.

If viewed from a legal perspective in Indonesia in responding to the current pandemic conditions, Indonesia actually has the right to implement vaccine and drug related patents. In article 109 paragraph 1 letter b of Law No. 13 of 2016 confirms that the government can implement its own patents based on considerations relating to state security or urgent needs for the benefit of the public and the implementation of patents by the government is limited and should not be sold at high prices and not for export.

This is certainly a manifestation of the compulsory license instrument which is one of TRIPS Safeguards through negotiations on patented pharmaceutical products in Indonesia. Moreover, this includes the category of “national emergency” that the compulsory license can actually be applied without negotiation through a voluntary exception mechanism. If we analyze together that in the midst of the current pandemic situations, the accessibility category of the distribution of COVID-19 drug patents is a top priority which has also been justified in Law No. 13 of 2016 in certain contexts. In the case that for the production of patent drugs that are available massively in the current emergency conditions, then other alternatives available in the patent system can also be through the mechanism of implementing patents based on “Government Use”. This is also justified in TRIPS Agreement Article 31, that it is possible for a country to

submit a compulsory license based on “Government Use” which is one of the reliefs to implement patents without permission from the patent owner.

Thus, the state simply has more intervention in carrying out positive coercion to the patent owner for the country’s needs indirectly, ignoring the exclusivity of the patent but focusing on being able to pay attention to the health of many people at a macro level while also paying attention to the effectiveness of the compulsory application of a “Government Use” based on its compulsory license. In accordance with Article 132 paragraph 1 letter d of Law No. 13 of 2016 which confirms that if the objectives of the compulsory license are not carried out which ultimately only harms the interests of the community.

In addition, Law No. 13 of 2016 also emphasizes the existence of parallel imports which are expected to be a guarantee for the existence of a fair price on the related patent in fulfilling a sense of justice from pharmaceutical products to human health needs. This can also be an alternative to access the pharmaceutical product which is urgently required for human health, especially if the COVID-19 drug patent has a fairly expensive price in Indonesia in accordance with Article 167 of Law No. 13 of 2016 letter a. What’s more, so far there has been no registration of drugs or vaccines related to COVID-19 registered in Indonesia. Homeland pharmacy and medicine products are also currently dominated by foreign industries. In fact, in terms of technology related to pharmaceuticals and medical devices to date, 95% of Indonesia’s pharmaceutical raw materials are imported products.4

As a result, the government is also acting progressively to be able to create regulations related to the acceleration of the development of the pharmaceutical and medical device industry through Presidential Instruction No. 6 of 2016 concerning the Acceleration of the Development of the Pharmaceutical Industry and Medical Devices, to be a form of manifestation of independence and enhance the competitiveness of the domestic pharmaceutical and medical device industry.

4Directorate General of Intellectual Property Ministry of Law and Human Rights of the Republic of Indonesia. “Pendaftaran Paten Obat Covid-19 Bisa Dilakukan Tanpa Mengorbankan Kepentingan Umum”, (DGIP, 2020) <https://dgip.go.id/pendaftaran-paten-obat-covid-19-bisa-dilakukan-tanpa mengorbankan-kepentingan-umum> accessed on 5 July 2020

CONCLUSION

In essence, behind the substantial translation of Law No. 13 of 2016 to the TRIPS Agreement shows great positivity that in the current emergency situation, the fundamental legal basis currently in effect directs the state and the pharmaceutical industry to prioritize the health of many people by prioritizing the accessibility of drug patents that can be produced massively as soon as possible with a slight exclusion of exclusivity toward the patent in the current situation.

The most important thing is that based on TRIPS Safeguards such as compulsory license, government use, to parallel importation, it is also a form of accommodation of international regulations harmonized with national regulations so that they can synergize with one another in order to create an accessibility of medicines which is an urgency in a focused pandemic situation as an irony which has not been resolved to date in various parts of the world.

BIBLIOGRAPHY

Aldila, Nindya. “Covid-19 Picu Ketidakpastian Bagi Industri Farmasi Global”. (Bisnis.com. 21 May 2020). <https://ekonomi.bisnis.com/read/20200521/257/1243443/covid-19-picu ketidakpastian-bagi-industri-farmasi-global> accessed on 5 July 2020

Directorate General of Intellectual Property Ministry of Law and Human Rights of the Republic of Indonesia. “Pendaftaran Paten Obat Covid-19 Bisa Dilakukan Tanpa Mengorbankan Kepentingan Umum”. (DGIP. 2020). <https://dgip.go.id/pendaftaran paten-obat-covid-19-bisa-dilakukan-tanpa-mengorbankan-kepentingan-umum> accessed on 5 July 2020

Ratanaprayul, Wongrat. “Pharmaceutical IP and competition law in Indonesia”. (Thomson Reuters Practical Law. 1 Jan 2020). <https://uk.practicallaw.thomsonreuters.com/w-015-

2428?transitionType=Default&contextData=(sc.Default)&firstPage=true&bhcp=1> accessed on 5 July 2020

Richard, Raymond R Tjandrawinata. The Healthcare System and the Pharmaceutical Industry in Indonesia. U.K: Palgrave Macmilan, 2013. Print

Sinaga, Selvie. “Ancaman Paten Terhadap Kesehatan Publik dan Safeguards Trips”. (Atmajaya.ac.id. 12 Oct 2015). <https://m.atmajaya.ac.id/web/KontenUnit.aspx?gid=artikel

hki&ou=hki&cid=ancaman-paten-terhadap-kesehatan-publik-dan-safeguards-trips#> accessed on 5 July 2020

United Nations Conference on Trade and Development. Development Dimensions of Intellectual Property in Indonesia:Access to Medicines, Transfer of Technology and Competition. New York and Geneva: UNCTAD, 2011. Print

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