Abstract

The TRIPS Agreement, or Agreement on Trade-Related Aspects of Intellectual Property Rights, has been crucial to international law since its inception. It delicately balances the two goals by fostering global trade while protecting intellectual property (IP) rights. The restrictions and freedoms imposed by TRIPS Agreement 31 and its annexed, TRIPS Agreement 31 bis, are examined in this overview. There has been a lot of discussion about the foundation of international law and the roots of coercive licensing.  Access to essential drugs and other sorts of copyrighted technology is a must for those living in impoverished countries. This is why TRIPS Agreement 31 and TRIPS Agreement 31 bis were created. When the World Trade Organization (WTO) was founded in 1995, the Trade Related Intellectual Property Rights (TRIPS) agreement was developed as a mechanism for regulating intellectual property rights in the context of international trade. The origins of international law provide a basis to better understand this. Its main goal was to promote innovation, creativity, and knowledge exchange while making sure that intellectual property rights wouldn't prevent people from accessing necessary resources, notably those in the field of public health. Under TRIPS Agreement 31, the area subject to required licensure is given one of the most considerable degrees of freedom. This law allows countries facing public health crises or difficulties to give licenses for the manufacture of copyrighted medications without the patent owners' permission. This is because it is believed that these countries are experiencing a public health emergency. They may make and sell cost-effective generic versions of essential pharmaceuticals as a result, making it easier for their people to access medicine when they need it. This makes it possible for these countries to market these generic substitutes to other countries. The Trade Agreement on Intellectual Property Rights Amendment 31 bis (TRIPS 31 bis) has greatly increased the flexibility of these options. Mandatory licensure facilitates and expedites access to drugs that are more readily and affordably available in other countries. This is a result of the legal need to possess a license. In the event of a national emergency, an exceptionally urgent crisis, or public use that is not for commercial advantage, the change does away with the necessity to initially negotiate with patent owners before giving a forced license. If the change is made, this is how things will be. The TRIPS Agreements 31 and 31 bis contain clauses that safeguard patent owners' rights even when they allow governments to impose compulsory licenses in the name of promoting public health. This is the case even though these agreements give countries the option to do so. For forced licensing to be considered lawful and for creators' intellectual property rights to be unfairly violated, certain conditions must be met, which are outlined in the agreements. These conditions must be satisfied for compelling people to obtain licenses to be regarded as legal.

Keywords: RIPS Agreement Agreement on Trade-Related Aspects of Intellectual Property Rights International law Intellectual property rights Global trade TRIPS Agreement 31 TRIPS Agreement 31 bis Flexibilities Compulsory licensing Access to essential drugs Impoverished countries World Trade Organization (WTO) Public health Innovation Creativity Knowledge exchange Copyrighted medications Generic versions National emergency Urgent crisis Public use Patent owners' rights Safeguards Promoting public health Conditions Legal considerations

The TRIPS Agreement, its Flexibilities, and the Genesis of Compulsory Licensing

TRIPS stands for Trade-Related Aspects of Intellectual Property Rights. A global harmonization and regulation of intellectual property rights having an impact on fields like patents, trademarks, copyrights, industrial designs, and trade secrets is the goal of this international agreement, which was administered by the WTO. The entity in charge of overseeing the agreement is the WTO. The provisions of this Agreement became enforceable on January 1, 1995. An important international agreement called the Trade Related Intellectual Property Rights (TRIPS) Agreement seeks to strike a balance between the protection of intellectual property rights and the advancement of broader social interests. It still affects several industries and economies around the world, as well as on the landscape of intellectual property protection and global trade.

Background

The GATT member countries' initial awareness of the significance of intellectual property rights in international commerce in the middle of the 1980s may be associated with the beginnings of trade-related intellectual property rights (TRIPS). The importance of technology and innovation in driving economic growth has made the protection of intellectual property a pressing concern for many countries. It has been stated that to handle these intellectual property rights and make it applicable on a worldwide level, a more thorough and persuasive framework is needed. The GATT framework was the subject of lengthy talks that started in 1986 over the inclusion of intellectual property. After significant debate, the signatory countries to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) pact finally became an agreement in December 1993. The agreement known as TRIPS was one of the main elements of the Final Act of the talks undertaken during the Uruguay Round. The Trade Related Intellectual Property Rights (TRIPS) agreement also entered into force on January 1, 1995, the same day the World Trade Organization (WTO) was founded, and it has since developed into a significant component of the WTO's legal structure.

Background of Fixabilities on TRIPS

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) was later adopted after the World Trade Organization (WTO) was established in 1995. The TRIPS flexibilities originate from these instances. International law has been changed by the TRIPS Agreement, which lays out key principles for the protection of intellectual property rights (IPRs), such as patents, trademarks, copyrights, and trade secrets, and their enforcement in the context of international trade.  The original incorporation of TRIPS into the larger WTO framework was a notable success since intellectual property was initially introduced within the system of international trade. Because each government utilized a different level of regulation to protect and enforce intellectual property, there were differences and disagreements in international trade prior to the TRIPS Agreement.  Worries regarding the potential negative effects of strict intellectual property protection, particularly on the accessibility of essentials, public health, and technological innovation, particularly in developing countries, started to emerge as the TRIPS deliberations carried on. Critics said that stringent IP enforcement might lead to the manufacturing of expensive drugs, monopolies, and the exclusion of underdeveloped nations from accessing and utilizing groundbreaking innovations.

Flexibilities of TRIPS Agreement

TRIPS (Trade-Related Aspects of Intellectual Property Rights) is an international agreement managed by the World Trade Organization (WTO), which establishes minimum standards for protecting and enforcing various forms of intellectual property (IP) rights like patents, trademarks, copyrights, geographical indications, and trade secrets. To accommodate the diverse levels of development and specific needs of member countries, TRIPS incorporates certain flexibilities. Here are some of the main flexibilities offered by TRIPS:

1.         Transition Periods: Developing countries and least-developed countries can benefit from transition periods, allowing them to postpone implementing certain TRIPS provisions. This extra time helps them adjust their legal systems and administrative structures to fully meet the TRIPS requirements.

2.         Compulsory Licensing: Member countries have the right to issue compulsory licenses, which permit the use of a patented invention without the patent holder's consent. This flexibility is essential during public health emergencies or other situations where access to critical medicines or technologies must be ensured.

3.         Bolar Exemption: The Bolar exemption allows generic drug manufacturers to conduct pre-marketing testing and experimentation on patented drugs before the patent expiration.

4.         Parallel Importation: TRIPS allows member countries to authorize parallel importation, enabling the import of genuine, patented products from another country without the patent holder's approval.

5.         Exceptions and Limitations: TRIPS recognizes the right of member countries to establish exceptions and limitations to intellectual property rights. These may include provisions for educational, research, and other public interest purposes.

6.         Public Health Safeguards: TRIPS contains provisions that empower member countries to implement measures essential for safeguarding public health and ensuring universal access to medicines. The Doha Declaration on TRIPS and Public Health reaffirms countries' right to prioritize public health over patent rights during health crises like HIV/AIDS, malaria, and other epidemics.

7.         Protection of Traditional Knowledge: TRIPS acknowledges the importance of safeguarding traditional knowledge, folklore, and cultural expressions of indigenous and local communities.  These flexibilities permit member countries to tailor their intellectual property systems to their unique circumstances while adhering to the minimum standards set by TRIPS. By utilizing these provisions, countries can strike a balance between protecting intellectual property rights and addressing their developmental needs and public welfare concerns, particularly for developing and least-developed nations.

Assessment from Compulsory Licensing Events: Lessons from a Successful Story

Case Study: India's Use of Compulsory Licensing for Antiretroviral Drugs

A good example of the efficacy of the approach is India's use of forced licensure to facilitate access to antiretroviral drugs for the treatment of HIV/AIDS. In accordance with Section 84 of the Patents Act, India issued its first compulsory licensing in 2012. This license is related to Sorafenib, a drug manufactured by Bayer and used to treat HIV. This choice enabled Indian pharmaceutical firms to create and market generic copies of the medication, making it significantly more affordable and available to those in need.

Lessons Learned:

1. Balancing Public Health and IP Rights: India's use of forced licensure to facilitate the availability of antiretroviral medications for the treatment of HIV/AIDS is a good illustration of the approach's effectiveness. India granted its first obligatory licencing in 2012 in compliance with Section 84 of the Patents Act. This licencing pertained to the Bayer medicine Sorafenib, which is used to treat HIV. This decision made it possible for Indian pharmaceutical companies to produce and distribute generic versions of the drug, thus reducing its cost and increasing its accessibility to individuals in need.
2. Utilizing TRIPS Flexibilities: The strategy adopted by India is a great example of how TRIPS flexibilities, in particular compulsory licensure, can increase access to important drugs. These flexibilities have the potential to make a substantial difference in addressing issues with public health and expanding access to life-saving medications when carefully considered and put into action.
3. Encouraging Domestic Pharmaceutical Industry: The Indian government's decision to require licensing has benefited the growth of the country's pharmaceutical industry. By enabling regional producers to create generic versions of the medication, it sparked competition, lowering costs and boosting availability.
4. Impact on Global Access: Antiretroviral medicine licensing regulations in India have an effect outside of its borders. India began manufacturing affordable generic copies of the medication that could be exported to other nations, especially those with low- and middle-income levels and comparable medical concerns.
5. Transparency and Clear Criteria: This effective illustration highlights the necessity for transparency and unambiguous standards when establishing forced licensing. India had good reasons for making such decisions, such as high costs and a lack of supplies. Such open decision-making can lessen potential legal issues and foster an environment where everyone feels more secure.
6. Engaging in Dialogue: Before using compulsory licensing, India made an effort to obtain a voluntary license by speaking with the patent owners. If these negotiations stalled, mandatory licensure was viewed as a last resort. This tactic emphasizes the importance of open dialogue before governments and patent holders take more harsh measures.

Case Study: South Africa's Use of Compulsory Licensing for HIV Medications

South Africa experienced a horrific HIV/AIDS epidemic at the beginning of the 2000s, and the high cost of antiretroviral medications severely limited access to care. The South African government modified its patent regulations to allow forced licensing for essential pharmaceuticals, including antiretroviral medications, in response to this public health emergency. The prospect of compulsory licensing nevertheless effectively pressured pharmaceutical companies to cut the price of their products, making HIV medications more accessible to South Africans, even though the precise forced licensing event was not put into effect.

Lessons learned

1. Using Compulsory Licensing as a Negotiating Tool: According to the strategy used in South Africa, the prospect of issuing obligatory licensing could prove to be a beneficial negotiating chip when dealing with pharmaceutical manufacturers. Patent owners should rethink their price and access policies if compulsory licensing is a possibility.
2. Encouraging Technology Transfer: Compulsory licensing can promote technology transfer and help to increase local manufacturing capacity by enabling generic companies to produce essential medications domestically. Long-term, this might result in healthcare systems that are more independent and effective.
3. Promoting Local Access and Export Potential: South Africa, like India, was able to increase regional access to affordable medications while promoting export possibilities. Other nations in the region coping with comparable health issues may have benefited from South Africa's availability of affordably priced generic medications.

Can Trips Agreement Be Implemented in Pakistan? Why hasn’t been it used?

Pakistan must adhere to all of the TRIPS Agreement's conditions and limitations because it is a member of the World Trade Organization (WTO), which mandates such compliance. For Pakistan to continue participating in the World Trade Organization (WTO), it must demonstrate that it complies with the standards and guidelines for intellectual property rights outlined in the TRIPS Agreement. These laws and regulations encompass patents, trademarks, copyrights, trade secrets, and other types of intellectual property rights.

The Trade Related Intellectual Property Rights (TRIPS) Agreement went into effect for all WTO members on January 1, 1995. Since then, Pakistan has been forced to abide by its conditions and fulfill them within the framework of its domestic legal system.

Pakistan might not have utilized certain TRIPS flexibilities, such as compulsory licensing, there could be several reasons:

1. Pharmaceutical Industry Interests: There is a potential that the pharmaceutical industry may try to impede the adoption of required licensure by using its clout both at home and abroad. Because they are aware that compulsory licensing may negatively impact their market share and revenues, patent owners frequently act combatively to maintain the exclusive rights that have been granted to them.
2. Political and Trade Pressures: Governments may come under political and commercial pressure from other countries, especially those that export considerable quantities of pharmaceutical products, to renounce or limit the use of TRIPS flexibilities.
3. Lack of Domestic Capacity: In other situations, governments can lack the technology resources and infrastructure necessary to properly employ TRIPS flexibilities like forced licencing. This includes having an awareness of generic drug development, legal procedures, and quality assurance.
4. Voluntary Licensing Agreements: Coercive licensing may not always be required because patent owners can freely engage with generic manufacturers.
5. Negotiations and Voluntary Price Reductions: Governments may try to bargain with patent owners to get voluntary price reductions or other access arrangements before turning to compulsory licensing.
6. Fear of Legal Challenges: In response to the deployment of TRIPS flexibilities like mandatory licensing, patent holders may bring legal objections, which could lead to time-consuming and expensive court fights.

Hamza Ali is an Economics student at National Defense University Islamabad. He is currently doing his internship in MOFA, Pakistan.