DIFFERENT BETWEEN INTERNATIONAL TRADE AGREEMENTS AND ACCESS TO MEDICINE FOR PROTECTION OF PUBLIC HEALTH

 

DIFFERENT BETWEEN INTERNATIONAL TRADE AGREEMENTS AND ACCESS TO MEDICINE FOR PROTECTION OF PUBLIC HEALTH:

 

ABSTRACT:

 

The issue of intellectual property, public health and access to medicines emerged in the World Health Organization (WHO) for the first time in 1996. The timing practically coincided with the end of the Uruguay Round and with the creation of the World Trade Organization (WTO). In 1995, the University of Madrid Carlos Tercero organized a conference together with the WHO Essential Medicines Program where Professor Carlos Correa presented a paper entitled “The Uruguay Round and Drugs.” The paper analyzes the possible implications of the TRIPS agreement on access to medicines and reveals the “margin of manoeuvre” that the Agreement has in order to protect Public Health. “The Uruguay Round and Drugs” is the first document that specifically alerts the health sector on the possible implications of the TRIPS agreement on public health and more specifically on access to medicines.

 

During the Uruguay Round negotiations (1986-1994) some negotiators from developing countries were already aware that the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) would have important implications on the pharmaceutical and health fields. It is well-known that the main lobby group during the Uruguay Round was the pharmaceutical industry, mainly interested in the adoption of the TRIPS agreement. Shortly after its adoption, The United Nations Conference for Trade and Development (UNCTAD) published a study on the TRIPS agreement and developing countries. In this article it is discussed how international communities agreed to provide the access to medicine through different international agreements.

 

1. INTRODUCTION:

 

The issue of intellectual property, public health and access to medicines emerged in the World Health Organization (WHO) for the first time in 1996. The timing practically coincided with the end of the Uruguay Round and with the creation of the World Trade Organization (WTO). In 1995, the University of Madrid Carlos Tercero organized a conference together with the WHO Essential Medicines Program where Professor Carlos Correa presented a paper entitled “The Uruguay Round and Drugs.” The paper analyzes the possible implications of the TRIPS agreement on access to medicines and reveals the “margin of manoeuvre” that the Agreement has in order to protect Public Health. “The Uruguay Round and Drugs” is the first document that specifically alerts the health sector on the possible implications of the TRIPS agreement on public health and more specifically on access to medicines.

 

During the Uruguay Round negotiations (1986-1994) some negotiators from developing countries were already aware that the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) would have important implications on the pharmaceutical and health fields. It is well-known that the main lobby group during the Uruguay Round was the pharmaceutical industry, mainly interested in the adoption of the TRIPS agreement. Shortly after its adoption, The United Nations Conference for Trade and Development (UNCTAD) published a study on the TRIPS agreement and developing countries.

 

2. DEVELOPMENT AND PROGRESS OF THE CONCEPT:

 

The concept to reduce the strict Rules of International Property Rights to access the medicine for the underdeveloped and developing countries are not an old concept. The development of this concept started after the establishment of different international organizations which specially deals with the protection of Human rights of the individual of whole over the world. In 1996 the World Health Assembly (WHA) adopted a resolution on medicines which constitutes the first mandate given by member States to the secretariat of the World Health Organization to work on intellectual property in relation to health. The resolution on “Revised Drug Strategy” requested the WHO Director-General to undertake a study on the impact of the WTO, and particularly the TRIPS agreement, on access to health.

 

2.1. THE “RED BOOK”:

 

Resolution requested the Director-General to prepare a study on the implications of the TRIPS agreement. This study was entrusted to the Program of Action on Essential Medicines (PAME). In November 1997, PAME published the study “Globalization and Access to Drugs: Perspectives on the WTO TRIPS Agreement,” commonly known in the WHO as the “red book” on the TRIPS Agreement.

 

2.2. TRIPS FLEXIBILITIES:

 

The aforementioned UNCTAD document includes the “room for manoeuvre” for the creation of national public policies that the TRIPS agreement has. The WHO “red book” speaks about “margins of freedom,”(1997) Subsequently, in March 2001, the WHO adopted the term “safeguards” in a widely distributed document available in the six WHO official languages. In June 2001, the European Commission talks about “a sufficiently wide margin of discretion” regarding the implementation of the TRIPS Agreement. A few months later, in November 2001, the Doha Declaration on the TRIPS Agreement and Public Health refers to “the provisions of the TRIPS Agreement that provide flexibility.” It is only in June 2002 that the WHO referred to TRIPS “flexibilities”, in a paper analyzing the implications of the Doha declaration, authored by Carlos Correa.

 

Currently, there is broad consensus on the use of the term “flexibilities” to refer to the mechanisms and provisions of the TRIPS agreement to protect public health.

 

2.3. THE COMMISSION ON INTELLECTUAL PROPERTY, INNOVATION AND PUBLIC HEALTH:

 

The Commission on Intellectual Property, Innovation and Public Health (CIPIH) was created in 2003 by a resolution of the World Health Assembly. WHO member States requested the WHO Secretariat to produce a report by independent experts.

 

In 2006, the group of experts published a report entitled “Public Health, Innovation and Intellectual Property Rights. It contains 60 recommendations, which have unfortunately not been fully adopted.

 

2.4. “GLOBAL STRATEGY AND PLAN OF ACTION ON PUBLIC HEALTH, INNOVATION AND INTELLECTUAL PROPERTY” RESOLUTION WHA:

 

This negotiation, which was two years long, can be considered the most relevant and important in the almost 70 years of existence of the WHO, second only to the negotiation and adoption of the convention against tobacco, FCTC.

 

In light of the pharmaceutical industry's inability to develop treatments for diseases that affect the majority of the world's population—those living in developing nations—the Global Strategy and Plan of Action (GSPOA) called for a significant reform of the pharmaceutical research and development system. One of the main barriers to access to medicines may be the intellectual property rights demanded by the TRIPS Agreement and recent trade agreements. The GSPOA critically analysed this reality and paved the way for the search for fresh approaches to this issue.

 

The Global Strategy and Action Plan on Public Health, Innovation, and Intellectual Property, which was adopted by WHO member states in 2008, was bogged down in "UN-like" discussions and procedures, and the results of this process were relatively meager.

 

Analyzing the progress made in implementing the “global strategy” and its action plan, the "progress" made so far is reduced to three points:

 

The Patent Pool, a particular initiative, this is one of the many elements of the mandate given to the WHO by resolution 61.21. Patent pools can facilitate equitable access and make new HIV treatments more affordable. They can also facilitate the development of new fixed-dose combinations suitable to address developing Intellectual Property, Public Health and Access to Medicines in International Organizations countries’ treatment needs. Patent pools may consist of compulsory licenses or licenses voluntarily granted by the patent holder, as is the case of the current Medicines Patent Pool (MPP) created with funds from the French initiative UNITAID. These patent pools are voluntary, and therefore they do not constitute a structural solution to the access to medicines problem. Unfortunately, in the case of the MPP, its existence has practically meant that the WHO has given up its work on advocacy and assistance to countries to implement the flexibilities of the TRIPS agreement.

 

The second activity that has been developed in the Americas region is the so-called “Platform on Innovation” promoted by the Pan American Health Organization (PAHO). It is a sort of, a virtual network reporting on various activities in the pharmaceutical field.

 

The “Demonstration projects”, an idea launched and promoted by the EU at the WHO. These demonstration projects, which were not part of the existing mandate in the various resolutions of the World Health Assembly, were used to delay the start of negotiations on a binding Convention. During 2012 and 2013, project selection took place in a process that involved the six WHO Regional Offices. This selection process was heavily criticized by non-governmental organizations and some observers. It confirmed the initial concern of developing countries that these demonstration projects were only a distraction by industrialized countries to delay the start of negotiations on a binding Convention.

 

More than 4 years after the approval of the “demonstration” projects, the funding is not there, at the end of 2016, to start this exercise. The start of negotiations for a Convention was not formally contingent on the results of the demonstration projects, but in practice the debate on the demonstration projects took so much space that the start of negotiations was set aside. If the demonstration projects were only a pretext for delaying the subject of a treaty, as many suspected, they were certainly “successful” as the treaty was not only delayed but virtually removed from the WHO agenda.

 

2.5. W.H.O. CONSULTATIVE EXPERT WORKING GROUP (CEWG):

 

The WHO Consultative Expert Working Group (CEWG) was established by the WHO Director-General at the beginning of 2011 to address the intellectual property issues left unresolved by the "Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property." In July 2011, the CEWG coordinator announced that “the CEWG will recommend to the 2012 World Health Assembly the initiation of formal intergovernmental negotiations for the adoption of a comprehensive and binding instrument for health R&D, on the basis of Article 19 of the WHO Constitution.” This recommendation has not yet been ratified by the Governing Bodies of the WHO.

 

2.6. THE COLLABORATION OF WHO WITH OTHER INTERNATIONAL ORGANIZATIONS:

 

Interestingly, the United Nations agencies invited to participate in the debates on intellectual property and health, which took place in WHO between 2010 and 2015, were WIPO and WTO. This is despite the fact that there are other United Nations agencies that are much closer to the work of the WHO, such as UNDP, UNAIDS, UNCTAD, or the Commission on Human Rights. These were not invited by the WHO to participate in the discussions on the subject of access to medicines. In the case of UNDP, its presence at the country level has been much more relevant in recent years than the rest of agencies mentioned above.

 

The "Promoting Access to Medical Technologies and Innovation" tripartite report has been one of the main areas of collaboration between WHO, WTO, and WIPO. Whereas the study could represent progress for WTO and WIPO given that it talks about the TRIPS flexibilities with no “taboos”, it does not reflect the fact that the WHO was the International Organization that had until then led this issue. There are 17 World Health Assembly resolutions referring to intellectual property and public health, adopted between 1996 and 2012, and these are cited by the report in a table on page 44. These resolutions clearly have a prescriptive character for the WHO Secretariat and for countries on how to preserve public health from the potential negative impact of new international trade rules on public health. Numerous WHO publications on this topic published over the past 15 years also point on this direction.

 

The disclaimer of the report states that the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the WHO, WIPO and the WTO be liable for any consequences whatsoever arising from its use.” This type of “disclaimer” may give the reader the misleading impression that the WHO has no opinion as to whether a compulsory license may, in particular circumstances, promote access to medicines, or whether an international exhaustion regime that allows parallel imports from any country can reduce medicines costs and, therefore, contribute to access. The 17 resolutions mandate the WHO to engage, promote and defend mechanisms and policies in favor of access. This tripartite report has led the WHO to share the “neutral” and totally disengaged view of safeguarding health.

 

The trilateral report is weak, unambitious and does not reflect the work that WHO has carried out under its mandate. It is curious that the 251-page document has no single recommendation, not even a conclusion. The dialogues or cooperation between the WHO, WIPO and the WTO from 2010 to 2015 have placed the international debate on access to medicines in a kind of “limbo”. This was undoubtedly one of the reasons why UNDP sought to rescue the issue by suggesting to the UN Secretary-General to convene a High-Level Panel on access to medicines by the end of 2015. The high-level panel of the Secretary released its report on 14 September 2016, to which we will refer at the end of this article.

 

3. THE WORLD TRADE ORGANIZATION AND PROTECTION OF PUBLIC HEALTH:

 

3.1. PARAGRAPH 6 OF THE DOHA DECLARATION:

 

The African Group asked the WTO TRIPS council to add a topic on "access to medicines" to its agenda in June 2001, and this request ultimately led to the Doha Declaration on TRIPS and Public Health. The WTO has only made this one contribution to the access to medicines debate over the past 15 years. The so-called “Paragraph 6” mechanism of the Doha declaration, or the Decision of 30th August 2003, was a mandate of the WTO ministerial conference in Doha (2001) to solve, in an “ad hoc” manner, a problem that affected the poorest countries. The problem still lacks a solution 15 years later. it is stated that any product manufactured under a compulsory license “shall be authorized predominantly to meet the supply of the domestic market”. This can be applied to countries with the capacity to manufacture medicines and limits the volume of medicines that can be exported when their production has been enabled by a compulsory license. Such disposition affects mainly those countries that lack the manufacturing capacity to produce medicines, i.e., the least developed countries. This is the reason why Paragraph 6 of the Doha Declaration gives a mandate to find an expeditious solution to this problem.

 

After two years of negotiations, on 30th August 2003, WTO Member States reached an agreement on the regulatory modification that would allow countries to import generic medicines at a lower price and manufactured under compulsory licenses, in case they lack local manufacturing capacity. After reaching this Decision, the President of the General Council read a declaration to clarify the way in which this Decision should be interpreted and implemented by WTO members. The purpose of this statement was to ensure to industrialized countries that the Decision would not be abused, it was never clear whether the statement by the President of the Council was part of the decision or not.

 

The decision on Paragraph 6 contains a number of conditions, requested by industrialized countries, to ensure that beneficiary countries can import generic medicines without undermining the patent system. These include measures to prevent drugs from being diverted to inappropriate markets, and provisions requiring governments using this system to keep all other Members informed.

 

All WTO Member countries are allowed to import under this decision, but the decision lists 23 developed countries that voluntarily announced that they would not use the system as importing Members: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Ireland, Iceland, Italy, Japan, Luxembourg, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

 

After joining the EU in 2004, 10 more countries have been added to the list: Cyprus, Slovenia, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, the Czech Republic and the Slovak Republic.

 

Subsequently, several potential exporting countries amended their laws and regulations with the aim of applying the exceptions and allow production exclusively for export: countries such as Norway, Canada, India and the EU among others. The 2003 exceptions are provisional in nature; the ultimate goal is to modify the TRIPS Agreement itself, which would enter into force when two-thirds of Members accept it. Thirteen years after the "expedited solution" was agreed upon by WTO Member States, only Rwanda has ever used the mechanism, and that was to import antiretroviral medications from Canada. After export, the manager of the Canadian generic company declared that his company had no intention of using the system again because it was so complicated.

 

At the end of the aforementioned seminar, organized by the South Centre at the WTO, Suerie Moon, Research Director at the Global Health Centre of the Graduate Institute in Geneva, concluded by citing the recommendations of the UN High Level Panel: “WTO member States should review the decision in Paragraph 6 to find a solution that would allow for a quick and convenient export of pharmaceutical products produced under a compulsory license. WTO member States should, as appropriate, adopt an exception and a permanent reform of the TRIPS Agreement.”

 

3.2. THE WHO PROPOSAL TO SOLVE THE PROBLEM:

 

In 2002, WHO published a document on the implications of the Doha Declaration on TRIPS and Public Health. This document describes possible solutions to the so-called “paragraph 6 problem” from a public health perspective. These characteristics include: a stable international legal framework; transparency and predictability of the rules to be applied in countries engaged in exportations and importations; simplicity and speed of legal proceedings in exporting and importing countries; equal opportunities for countries in need of medicines, including for products patented in the importing country; multiplication of potential providers of needed medicine; and a wide coverage in terms of health issues and different drug types. Thus, the basic public health principle is clear: people in a country that does not have the capacity for domestic production of a needed drug should not be less protected by the provisions of compulsory licenses (or other safeguards of the agreement on TRIPS), nor should they have more procedural obstacles compared to people living in countries with the capacity to produce the drug.

 

Among the solutions that have been proposed, the limited exception under article 30 is the most consistent with these public health principles. Under the mandate of the Doha Declaration, this solution would give WTO member States expeditious authorization to enable third parties to manufacture, sell and export patented medicines and other health technologies to address public health needs.

 

3.3. THE WORLD INTELLECTUAL PROPERTY ORGANIZATION:

 

WIPO is the largest donor offering training on intellectual property issues to developing countries, according to Carolyn Deere. WIPO spent more than $400 million on technical assistance between 1996 and 2006. The problem is that this technical advice, according to Carolyn Deere, was used to introduce stronger intellectual property management in developing countries, with the philosophy that "the more patents, the better".  All of this is done in order to persuade decision-makers to strengthen the use of intellectual property through the provision of computers, computer equipment, salaries, invitations to conferences, and consulting contracts.

 

When looking at the schedules of the various WIPO training programs, which are available online and include training courses, none of them mention the TRIPS agreement's flexibility. For those who have been following this debate for the last 15 years, it is clear that WIPO is more a part of the problem than the solution in terms of public health. WIPO is certainly responsible for the proliferation of patents on trivial innovations that result in expensive pharmaceutical products. In the WIPO website, WIPO identifies its main activity, in the field of medicines, to be the fostering of a trilateral cooperation between the WHO, the WTO and WIPO. This point has been already mentioned and analysed in the section referring to WHO.

 

The webpage concludes by saying: “The three organizations meet regularly, exchange information on their respective work programs, discuss and plan, within the possibilities of their respective mandates and budgets, common activities. The trilateral cooperation is intended to contribute to enhancing the empirical and factual information basis for policy makers and supporting them in addressing public health in relation to intellectual property and trade.” There is no reference to what part of the work of the tripartite collaboration is devoted to supporting countries in the use of TRIPS flexibilities.

 

4. THE UNITED NATIONS CONFERENCE ON TRADE AND DEVELOPMENT ON PROTECTION OF PUBLIC HEALTH:

 

The United Nations Conference on Trade and Development (UNCTAD) has focused its access to medicines work on strengthening production capacity in developing countries. In 2005, UNCTAD was mandated by the Commission on Investment, Technology and Financial Issues to carry out work related to the manufacture and supply of pharmaceuticals in the context of the Millennium Development Goal.

 

The Commission recommended that: “UNCTAD should, within its work program on investment, technology transfer and intellectual property, assess ways in which developing countries can develop their domestic productive capability in the supply of essential drugs in cooperation with pharmaceutical companies.”

 

Within the framework of this mandate, UNCTAD established in 2006 a pilot program on local pharmaceutical production and access to medicines, with the financial support of Germany and the United Kingdom. The aim of the program: “The overall objective of the program is to assist developing countries – and least-developed countries (LDCs) in particular – to establish domestic intellectual property regimes that facilitate increased access to affordable medicines...”

 

Within the activities foreseen by this program, there are training courses on TRIPS flexibilities applied to local pharmaceutical production. Among the studies published by UNCTAD there are: “Role of competition in the pharmaceutical sector and its benefits for consumers” or “Enhancing productive capacities: the role of health”

 

4.1. THE JOINT UNITED NATION PROGRAMMERS ON HIV/AIDS:

 

The 2016-2021 Strategy of the UNAIDS Program the objectives of the programs are as follows-

 

1. To reaffirm the work of promoting innovation and continuous improvement of HIV-related medicines and technologies while ensuring their availability, quality and affordability.

 

2. To support countries in the adoption and use of TRIPS-related flexibilities and in defending their ability to denounce the provisions of trade agreements that impede access to affordable medicines that go beyond international obligations under the TRIPS Agreement.

 

3. Joins efforts to explore new systems of incentives for research and development where research and development costs are de-linked from product prices.

 

4.2. SOME EXAMPLES OF THE CURRENT WORK OF UNAIDS ON IP-RELATED ISSUES:

 

Information papers on IP-related issues have been developed by the UNAIDS / UNDP secretariats: the impact of IPRs on access to medicines, the challenges of IP chapters in free trade agreements.

In 2013, UNAIDS, UNITAID, WHO and the Brazilian Government organized a consultation on access to HIV medicines in middle-income countries. There were four blocks of recommendations: pricing; regulatory framework; IP and collaboration on local production; and R&D.

In May 2014, UNAIDS co-sponsored a BRICS side event during the World Health Assembly to discuss access to medicines in the context of members of this group of countries. IP was an important item on the agenda.

In May 2015, UNAIDS organized a reflection group on IP and access to medicines to inform the secretariat on possible areas and actions that UNAIDS could undertake to improve access to medicines and address barriers to Intellectual property.

In October 2015, UNAIDS, in collaboration with MSF, the Third World Network and the People's Health Movement, organized a session on TRIPS and access to medicines at the WTO Public Forum in Geneva.

Finally, it is worth mentioning that UNAIDS was part of the Secretariat of the UN SG High-level Panel that issued their report in September 2016.

 

4.3. THE HUMAN RIGHTS COUNCIL:

 

Access to medicines is a fundamental element to the full exercise of the right to health, which was reiterated in a resolution adopted by the UN Human Rights Council in 2016. Members also agreed to hold round tables on the issue of access to medicines during the next sessions, in 2017. Resolution 32/L.23 titled: Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” was submitted by Brazil, China, Egypt, Haiti, India, Indonesia, Paraguay, Peru, Senegal, Sri Lanka, South Africa and Thailand. The resolution was supported by 72 co-sponsors.

 

In the context of the WHO, numerous resolutions have been adopted over the past 15 years. There, the primary conflict has been between trade and health. Developing nations have tried to use human rights as a justification for ensuring access to medications on a number of occasions. Unfortunately, due to resistance from the United States of America, all attempts failed.

 

The great value of the Human Rights Council resolution 32/L.23 is to place the debate on access to medicines at another level, at the level of human rights. It may not be just by chance that in December 2015 the UN Secretary-General called for the High-Level Panel with the following terms of reference: to study the incoherence between inventors’ rights, international human rights law, trade rules and public health.

 

The Human Rights Council confirms the primacy of human rights, such as the right to health over trade, intellectual property rights and other bilateral investment or trade agreements. “It is equally important that the resolution reaffirms the ability of countries to take advantage of the flexibilities envisaged by the Agreement on Trade-Related Aspects of Intellectual Property  Rights to promote access to medicines, recognizing that patents can be used to set high prices for medicines.”

 

The resolution reaffirms the importance of access to medicines for all human beings as one of the fundamental human rights and stresses that improved access could save millions of lives every year.

 

The resolution also refers to the Doha Declaration on intellectual property and public health which confirms that TRIPS does not prevent and should not prevent WTO members from taking measures to protect public health. the adoption by consensus of the resolution coincided with the celebrations of the 30th anniversary of the Declaration on the Right to Development, which recognized both the right to health and access to medicines and public health as essential elements for the exercise of the right to development.

 

4.4. THE UNITED NATIONS PROGRAMMERS FOR DEVELOPMENT:

 

The UNDP's approach to intellectual property and medication access has been to situate all of its work within the context of the war against HIV. In other words, UNDP prioritizes ensuring that people living with HIV have access to medications. This is a very successful strategy since the drugs used to treat HIV are excellent examples of drugs marketed under conditions such as monopolies, high prices, unethical behavior, and human rights violations.

 

These problems are widespread among many other medicines, to which many people worldwide do not regularly have access.

 

HIV AND HEALTH:

 

As per the UNDP website “Globally, 35 million people are living with HIV. While new HIV infections have declined by 38 per cent since 2001, the HIV epidemic continues to outpace the response.” However, as per the UNDP: “There is a growing threat from non- communicable diseases (NCDs) such as cardiovascular diseases, cancers, chronic respiratory diseases and diabetes - accounting for 60 per cent of premature deaths. Over the next twenty years, NCDs and mental health will cause a cumulative economic output loss of US$ 47 trillion globally.”

 

The UNDP Strategic Plan 2014-2017 “Recognizes the broad range of social and economic impacts of HIV and the synergies between health and sustainable development. This plan addresses HIV as a cross-cutting issue and emphasizes the rights of people living with HIV; reducing associated discrimination and violence against women; empowering local governance and national capacities to achieve greater equity in access to services for those affected, and strengthening the rule of law and reform of legal systems.”

 

This report is undoubtedly one of the most robust works produced by a UN agency in the field of health, access to medicines and in particular intellectual property. The legal environment – laws, repressive and judicial systems – has immense potential to improve the lives of people who do not have access to medicines and can save their lives. International laws and treaties can protect and improve access to healthcare and forbid discrimination stimulating the power of national laws to protect health and to ensure access to medicines as a right. This 162-page report presents compelling evidence and recommendations that can save lives, reduce costs, help eradicate the AIDS epidemic, and improve access to medicines in general. Laws can prohibit or permit specific behaviors, and in doing so they shape policies economies, and society. Laws can be an excellent tool to protect and guarantee the health of citizens.

 

4.5. COLLABORATION BETWEEN WHO, UNDP AND UNCTAD:

 

Under the TRIPS Agreement, for a product or a manufacturing process to be patentable it has to meet the patentability requirement. These criteria are required by national intellectual property offices, and they are: novelty, inventiveness and industrial application. However, these three elements are not defined in the TRIPS agreement; therefore, WTO member States are free to define these three elements in a manner that is coherent with the public health objectives.

 

According to the report of the United Nations High Commissioner on Health:

 

“The requirements under the TRIPS Agreement for the grant of patents – novelty, inventive step and industrial applicability – are open to interpretation under national legislation and each country can decide according to local conditions. Consequently, the High Commissioner encourages interpretations of these requirements that do not lose sight of the public interest in the wide dissemination of knowledge. The world has never had at its disposal such a wide arsenal of treatments to fight the diseases that afflict humanity. At the same time, many people die owing to a lack of certain medicines and/or vaccines. This applies to illnesses such as AIDS, malaria, tuberculosis, cancer, diabetes, hepatitis C, bacterial meningitis and pneumonia, among many others.”

 

It is widely believed that patents are usually granted to protect new drugs, but the number of patents obtained annually to protect new compounds is actually very small and has been declining. Each year, thousands of pharmaceutical patents are awarded, although only a few are for new molecular entities (NMEs).

 

The cumulative nature of innovations, due to low patentability requirements and deficiencies in patent granting procedures, has important consequences on the patent system, which limits the dissemination of the innovations that the system seeks to promote access to life-saving drugs. “Patents that are based on broad scientific principles are generally bad, because according to the United States Supreme Court, they may confer power to block off whole areas of scientific development, without a compensating benefit to the public.”

 

All of this led WHO, in collaboration with UNCTAD, UNDP and ICTSD, to develop, in 2007, a series of guidelines for the examination of pharmaceutical patents from a public health perspective. These guidelines were conceived as a contribution to improve the transparency and effectiveness of the patent system for pharmaceutical products. This would help countries to pay more attention to patent examination and grant procedures, in order to avoid the negative effects of patents on non-inventive developments on access to medicines.

 

The exercise to draft guidelines for patent examination sought a way to manage the pharmaceutical product patent system and, more specifically, the ‘strengthened patent system’ arising from the TRIPS Agreement and current regional and bilateral trade and investment agreements. Patents are a social contract between the patent holder and society; therefore, it is necessary to explore, identify and implement mechanisms to improve the functioning and transparency of the patent system in the interest of public health.”

 

The report of UN SG’s high-level panel, to which we will refer next, recommends to “make use of the space available in Article 27 of TRIPS to adapt and apply rigorous definitions of invention and patentability. “The guidelines for the examination of pharmaceutical patents published by the three agencies WHO, UNDP and UNCTAD are precisely the means to put into practice that recommendation.

 

5. CONCLUSION:

 

In the last 15 years, a lot of material has been published in the area of public health and intellectual property. There have been World Health Assembly resolutions, 17 of them; and numerous WHO publications; and publications from academia and NGOs, that have analyzed and provided guidance on how to protect access to health vis a vis the new international trade rules required under the WTO. Also, important recently are the free trade agreements and bilateral investment agreements that contain clauses and conditions that are more stringent than the standards of the TRIPS agreement. In terms of technical assistance to countries for their use of TRIPS flexibilities, the position of WHO seems to have had a turnaround in the last 3 years, due apparently to its alliance with WTO and WIPO. The collaboration between WHO, WTO and WIPO is a good thing, as long as the mandate given by WHA resolutions is respected and implemented. In terms of international trade and investment agreements, WHO cannot have a “neutral position”: its mandate is already biased by the perspective of public health and the mandate given by the different resolutions of the World Health Assembly in recent years. International trade rules and public health matters are two different regimes that should not be equated. In the first case, we are talking about norms and rules of the economy and in the second case; we are dealing with the right to health as a fundamental human right.

 

In this regard, the pronouncements of the Commission on Human Rights and the UN SG High- level panel are fundamental and can relaunch the debate that has been “dormant” in the WHO for the last 5 years. In the future we will see whether the WHO Secretariat and Member States arrive to an understanding that working and supporting countries in the field of public health and intellectual property is an opportunity rather than a problem to be avoided. It is an opportunity, such as in the case of a possible international treaty to finance pharmaceutical R&D, which could help this United Nations specialized agency to rediscover its identity and a reason to be in the twenty-first century.

 

Finally, it is important to note that the international organizations are at the service of the member states, which means that countries can always request an additional specific mandate, or demand that in the areas where there is a mandate, this mandate is actually executed.