Doha Declaration and Trips amendment
The Doha Declaration and the TRIPS Amendment have significant implications for
pharmaceutical law, particularly with respect to intellectual property rights (IPR), as they seek to
balance the protection of patents with the public interest, especially in developing countries.
1. Doha Declaration (2001):
The Doha Declaration on the TRIPS Agreement and Public Health was adopted by the World
Trade Organization (WTO) Ministerial Conference in 2001. It acknowledges that the TRIPS
(Trade-Related Aspects of Intellectual Property Rights) Agreement should not prevent countries
from taking measures to protect public health, particularly with regard to access to essential
medicines.
Key points of the Doha Declaration include:
• Flexibility in Patent Law: The declaration reaffirmed that countries have the right to use
TRIPS flexibilities to protect public health. These include mechanisms like compulsory
licensing and parallel importing. These mechanisms allow governments to circumvent
patent protection in cases of public health crises, such as the HIV/AIDS epidemic.
• Compulsory Licensing: This allows a government to authorize a third party to produce a
patented drug without the consent of the patent holder, under certain conditions. This is
particularly important for ensuring access to affordable medicines in developing
countries. The Doha Declaration clarified that TRIPS should not prevent countries from
issuing compulsory licenses to address public health needs.
• Public Health Priority: The declaration emphasizes the need to ensure that intellectual
property rules do not interfere with the ability of countries to protect public health and
ensure access to medicines for all.
2. TRIPS Amendment (2017):
The TRIPS Amendment, also known as the Paragraph 6 System of the TRIPS Agreement, was
adopted in 2003 in response to the Doha Declaration. The amendment facilitates the production
and export of generic versions of patented medicines to countries that do not have the capacity to
manufacture them.
• Paragraph 6: The TRIPS Amendment allowed countries that do not have the capacity to
produce generic medicines to import them from other countries. This is particularly
beneficial for low-income countries that cannot produce certain essential medicines due
to the high cost of patented drugs.
• Export of Generic Medicines: This provision ensures that a country issuing a
compulsory license can export the generic medicine to another country with a public
health problem, without violating international patent law.
3. Pharmaceutical Law in IPR (with respect to TRIPS and Doha):
In the context of pharmaceutical law, both the Doha Declaration and the TRIPS Amendment
underscore the need to balance the enforcement of intellectual property rights with public health
concerns. Some key aspects of pharmaceutical law affected by these instruments include:
• Patents and Generic Drugs: Patents grant exclusive rights to pharmaceutical companies
to manufacture and sell their inventions, usually for a period of 20 years. However, when
patents are granted for essential medicines, high prices may restrict access. The Doha
Declaration allows developing countries to issue compulsory licenses to manufacture or
import generic drugs, helping make essential medicines affordable.
• Public Health vs. Patents: The Doha Declaration emphasizes that public health concerns
must take precedence over patent protection, particularly when access to life-saving
medicines is at risk.
• TRIPS Flexibilities: The TRIPS Agreement itself provides several flexibilities for
developing countries to address public health needs:
• Compulsory Licensing: Allows the government to issue
licenses without the patent holder’s consent.
• Parallel Importation: Allows countries to import patented
medicines from other countries where they are sold at lower
prices, circumventing the patent holder’s control over pricing.
The Doha Declaration on TRIPS and Public Health
The Doha Declaration on TRIPS and Public Health was adopted in 2001 by the World Trade
Organization (WTO) members in response to growing concerns about the impact of intellectual
property rights (IPR) on access to essential medicines, particularly in developing and least-
developed countries (LDCs). The declaration was a landmark response to the challenges of
balancing the protection of intellectual property with public health needs, especially in the
context of the global HIV/AIDS crisis and other public health emergencies.
Circumstances Necessitating the Doha Declaration
• Global HIV/AIDS Epidemic: In the late 1990s and early 2000s, there was a growing
crisis in developing countries, particularly in sub-Saharan Africa, where millions were
dying from HIV/AIDS. Many of these countries faced an acute shortage of affordable
life-saving medicines, as pharmaceutical companies held patents on essential drugs, such
as antiretrovirals (ARVs) used to treat HIV/AIDS. The high cost of these patented drugs,
due to exclusive market rights granted by patents, made them inaccessible to the vast
majority of people in these regions.
• High Cost of Essential Medicines: Patents granted under the TRIPS Agreement, which
came into effect in 1995, provided pharmaceutical companies with the exclusive right to
manufacture and sell patented drugs for up to 20 years, effectively creating monopolies.
In countries with limited resources, the high prices of patented drugs became a significant
barrier to accessing essential medicines, leading to growing public health crises.
• Challenge of Access to Medicines in Developing Countries: Developing and LDCs
argued that the TRIPS provisions were conflicting with their need to ensure access to
affordable medicines, particularly in the context of public health emergencies. The
concern was that the strict enforcement of patents would hinder the ability of countries to
use generic drugs or engage in other mechanisms (such as compulsory licensing) to lower
drug prices and increase access.
• International Pressure and Protests: In the late 1990s, protests and campaigns led by
civil society organizations, advocacy groups, and international public health bodies
pressured governments and international organizations, including the WTO, to address
the issue of access to medicines. High-profile cases, such as the South African
government's attempt to import generic ARVs for HIV/AIDS treatment in 1997,
highlighted the tension between IPR protection and public health needs. Pharmaceutical
companies threatened legal action, claiming violations of their patents under TRIPS.
The Doha Declaration: Objectives and Key Provisions
In light of the above circumstances, the Doha Declaration was adopted at the WTO Ministerial
Conference in November 2001. The declaration aimed to clarify and reinforce the rights of
WTO members to prioritize public health over strict adherence to TRIPS obligations, particularly
in situations of public health crises.
Key Provisions and Changes Introduced by the Doha Declaration
• Clarification of TRIPS Flexibilities: The Doha Declaration affirmed that the TRIPS
Agreement should not prevent members from taking measures to protect public health. It
specifically recognized the flexibility of TRIPS to allow countries to:
• Issue compulsory licenses for the use of patented medicines
without the consent of the patent holder.
• Import and export generic medicines in the event of a public
health crisis, ensuring that the patent-holder's monopoly does
not limit access to essential medicines.
The declaration made it clear that Article 31 of TRIPS (on compulsory licensing) allows
members to grant licenses for patented drugs in certain circumstances, such as when the
public health interest outweighs the interests of the patent holder.
• Compulsory Licensing and Parallel Importation:
• Compulsory Licensing: The declaration reaffirmed that
countries could issue compulsory licenses under the TRIPS
Agreement to allow the local manufacture or import of generic
versions of patented drugs. This mechanism would enable
countries to circumvent the patent holder's monopoly and lower
the cost of essential medicines.
• Parallel Importation: The declaration also recognized the right
of countries to engage in parallel imports, where cheaper
generic drugs can be imported from other countries without the
consent of the patent holder, provided they are sold at a lower
price.
• Public Health Prioritization: The declaration stressed that public health policies should
take precedence over patent protection. This was particularly relevant in situations
involving life-threatening diseases like HIV/AIDS, tuberculosis, and malaria, where
countries facing epidemics could act to secure access to affordable medications.
• Access to Medicines for Developing Countries: The declaration recognized the
importance of ensuring that developing countries and LDCs could access affordable
medicines, especially in the face of public health emergencies. It emphasized the right of
WTO members to adopt measures that facilitate access to medicines, even if such
measures were in tension with patent protection.
• Waivers for LDCs: One of the key outcomes for LDCs, including countries like
Matumaini, was the transitional period provided for the implementation of patent
protections on pharmaceutical products. LDCs were granted an exemption from
implementing patent protections on pharmaceutical products until 2026 (with the
possibility of an extension). This allows LDCs to continue producing generic versions of
medicines without infringing on patents, addressing critical public health needs.
• Generic Medicines Production and Export: The declaration sought to address the
specific concern of access to medicines for countries that did not have the manufacturing
capacity to produce their own medicines. In response to this, the 2003 WTO waiver
allowed countries without the capacity to produce pharmaceuticals to import generic
medicines from countries that could produce them under compulsory licenses, thus
ensuring access to medicines during public health emergencies.
Cases Highlighting the Impact of the Doha Declaration
• Case of South Africa (2001): In 2001, South Africa passed the Medicines and Related
Substances Control Amendment Act, which allowed for the importation of generic
versions of patented ARVs and other essential medicines. The pharmaceutical industry
challenged this law, claiming it violated TRIPS. The Doha Declaration provided legal
clarity that the TRIPS Agreement did not prevent South Africa from using compulsory
licensing and parallel imports to ensure access to medicines. The declaration effectively
supported the South African government's right to take such actions in the public health
interest.
• Brazil’s Use of Compulsory Licensing (2007): Brazil issued compulsory licenses for the
manufacture of generic versions of patented HIV/AIDS drugs in 2007, citing the need to
reduce the high cost of treatment. The Doha Declaration was instrumental in ensuring
Brazil's ability to defend this action under TRIPS flexibilities. Brazil successfully argued
that it was acting in accordance with public health priorities, consistent with the
objectives of the Doha Declaration.
Conclusion
The Doha Declaration on TRIPS and Public Health was a response to the public outcry over
the high cost of essential medicines and the restrictive impact of patents on access to health care,
particularly in the developing world. It introduced key flexibilities within the TRIPS Agreement
to allow countries to prioritize public health by issuing compulsory licenses, engaging in parallel
imports, and taking other actions to ensure access to affordable medicines during health
emergencies. The declaration also provided LDCs with exemptions from patent obligations,
giving them more time to develop their own pharmaceutical industries. Through these changes,
the Doha Declaration marked a crucial shift toward a more balanced approach between IPR
protections and public health needs in the global pharmaceutical landscape.
