A Project of the American Enterprise Institute and the Federalist Society

Daily reports from the 2006 WHO World Health Assembly, May 22-27

NGOWatch Report

The 59th World Health Assembly, the annual meeting of the World Health Organization, opens on Monday in Geneva with controversial proposals to limit the intellectual property rights of pharmaceutical companies and the role of developing country governments in health research high on the agenda.

The World Health Assembly is the forum through which the World Health Organization (WHO) is governed by its 192 member states. It is the world's highest health policy setting body and is composed of health ministers from member states.

The main tasks of the World Health Assembly are to approve the WHO programme and the budget for the following biennium and to decide major policy questions.

Please click here for the agenda.

May 21, 2006

John S. Gardner reports on pre-World Health Assembly events held on Sunday, May 21.

Connoisseurs of the literature on free market economics will recall Frederic Bastiat's "Petition of the Candle makers," in which he imagined a petition from the candle makers to force people to close their shutters in the daytime, so to increase sales of candles. Here, the day before the World Health Assembly opens, there is some good news from the land of Bastiat and the francophone community: the organization LEEM ("Les enterprise en medicament") sponsored a meeting to discuss challenges facing the francophone countries and the role of the pharmaceutical industry in meeting them.

The meeting began with a presentation from Mme. Maiga Zeinab Mint Youba, Health Minister of Mali, who spoke on pandemics, comparing the toll of AIDS to that of the plague in Europe in 1346-1350 and to the Spanish flu of 1918-19. Today, whether the subject is AIDS or a potential bird flue epidemic, it is the poorer countries which will have to bear the brunt of the epidemic. She reminded the audience that 65% of new HIV infections registered in 2005 still occurred in sub-Saharan Africa and that 90% of the one million deaths from malaria each year occur in Africa. One solution she proposed is to move towards a system in which affected countries are able to produce the medicines to combat these diseases themselves.

The presentation raised a number of questions: would those medicines be produced under license from the patent owners (for medicines which are still under patent), or not? Patent license holders would have a strong interest in ensuring that medicines produced anywhere are subject to the same strict manufacturing controls as in the West and thus be of the same quality. Will some poorer countries have the capacity to conduct strict inspections of manufacturing facilities? Would it be best to work with the license holders to develop systems of inspection for drugs produced in markets not regulated by a strict regulatory authority?

Dr. Mohammed Jawad Khalife, Minister of Public Health of Lebanon, delivered a talk on "Access to Health in a country under reconstruction." Lebanon has moved swiftly to improve healthcare for the Lebanese people after the brutal and devastating civil war by relying primarily on the private sector for health care. For all those in the US who criticize the high level of GNP spending on health and want to see us move to European levels of 7-9%, please note that Lebanon spends 12% of its GNP on health care -- a strong result. This amounts to US $2 billion, or about $500 per person per year. Twenty percent of this spending is public, 80% private, and the country has a good ratio of physicians and hospital beds for its primarily urban population. The country spends about $400 million per year for prescription drugs, and 62% of Lebanese have some form of coverage, through public or private insurance, for drugs. Further, the country is considering a new law for protection of intellectual property rights in pharmaceuticals and is supporting improving drug regulation and inspection measures. In a somewhat different veil, Lebanon has introduced a new law aligning the public prices of drugs with prices in neighboring countries.

While it is true that Lebanon has a higher per capita income than many other developing countries, its strong reliance on the private sector -- doctors, hospitals, and insurance -- have some believing it can serve as a model for many poorer countries. Lebanon's dual Arab and francophone heritage may give it numerous opportunities to spread the news about the role of the private sector in healthcare.

Finally, two officials, Valerio Reggi from the WHO and Jean Parrot, President of the International Pharmaceutical Federation and head of the French National Council of Pharmacists, spoke on the growing danger of counterfeit drugs and the serious threat they pose to human health. Dr Reggi began with a clear message: counterfeit drugs kill! Counterfeiting of drugs is a serious crime which endangers the health of everyone. It is emphatically not merely an issue of intellectual property but rather a public health issue in its own right. Why? Because counterfeit drugs may have a different (or even no) active ingredient and are general of worse quality than legitimately manufactured and inspected drugs, whether original or generic. He noted that the problem is growing; it manifests itself at the national level, but the problem is international, through illicit transactions and smuggling operations. Thus the WHO has begun the IMPACT program to fight counterfeiting through promoting better international coordination on the issue (including work with Interpol) and the development of model national legislation and regulations to address the issue, as well as helping countries themselves develop systems to spot counterfeit drugs before they are given or sold to unwitting and unfortunate patients. The international pharmacy organizations are addressing this as well: 32 francophone pharmacists' organizations, primarily in Africa, agreed to focus attention on the issues, including providing practical help to local pharmacists in spotting counterfeit drugs.

John S. Gardner is the former General Counsel of USAID and a former Deputy Assistant to President Bush. He is attending the World Health Assembly on behalf of the Federalist Society.

May 22-23, 2006

The fight against malaria

In her address in the plenary session of the World Health Assembly, the Hon. Dr. M. E. Tshabalala-Msimang, specifically called for the WHO to "extend its leadership" in fighting malaria "to indoor residual spraying with DDT." There is a legal issue at hand: specifically, whether the Stockholm Convention on Persistent Organic Pollutants of May 2001 (which entered into force in May 2004) contains an exception for the use of DDT for malaria control. Secretary of State Colin Powell said that it did on April 19, 2001, when he announced that the US would sign the Convention. And the UN Environment Programme has noted that "the use of DDT for disease vector control under World Health Organization guidelines is considered an acceptable purpose because it is still essential in many countries to control malaria transmission by mosquitoes. This will permit governments to protect their citizens from malaria - a major killer in many tropical regions - until they are able to replace DDT with chemical and non-chemical alternatives that are cost-effective and environmentally friendly." For the most affected countries, particularly in Africa, that time has not arrived, when every year there are estimated to be 300 million cases of malaria leading to one million deaths. In addition to the high death rate it causes, sickness from malaria has a negative impact on economic growth, taking workers out of the workforce during their or their children's illness and forcing the poor to spend scarce resources on anti-malarials or go untreated.

Draft global strategy on sexually transmitted infections

Among other items, the World Health Assembly is considering this week a document entitled "Prevention and control of sexually transmitted infections: draft global strategy." The WHO estimates that there are over 340 million new cases of sexually transmitted infections each year, including HIV and human papilloma virus, which increases the chances that a woman will develop cervical cancer, the second-largest cause of cancer-related deaths worldwide among women. Congenital syphilis leads to almost 500,000 stillbirths and prenatal deaths in Africa alone, again according to WHO. The word "abstinence" appears not to have been included in a 60-page report that was released. Instead, the strategy focuses on "user-friendly services for adolescents" directed "to reach as many adolescents as are in need" (which according to some activists on the issue is all adolescents) and elsewhere speaks of "multi-purpose youth health centers." The closest the report comes is to recommend "age-appropriate" interventions and using "messages that are sensitive to gender and culture."

As part of the potential solution, the report does specifically mention faith-based organizations as "partners in the design, implementation, and evaluation of interventions [.]"

The Prince of Wales on integrative health.

One highlight of yesterday's plenary session of the WHA was a speech from the Prince of Wales on integrative health. Perhaps realizing the skepticism of some in the audience, he began in a self-deprecating manner, noting that those who had heard him on the issue before knew he was going to speak on integrative health as opposed to traditional medicine. The Prince began by stating that the prevalent view of healthcare relies on a "dangerously fragmented and abstract view of the world," leading to the "abandonment of much traditional knowledge and wisdom." Instead, he proposes a view of healthcare where "the best of the ancient is integrated with the best of the modern." He noted that 35 million out of the 58 million deaths occurring each year result from chronic diseases (such as cardiovascular diseases, diabetes, arthritis, and the like), which belong to rich and poor nations alike. Charles promotes a vision of personal responsibility in saying that "The state of our health reflects the food we eat, the exercise we take, the water we drink" but he looks into different and less strictly scientific territory in noting that factors such as love and self-respect belong to health as well; "health is the sum of all these parts."

The Prince noted there is real danger from the potential loss of medical knowledge in oral and non-Western traditions. Artemisinin, for instance, is a part of anti-malarial therapy. And he stated that there is evidence for practices such as acupuncture that even if we don't know how they work, we know that they do work. The Prince concluded his remarks by challenging countries to develop national strategies for a collaborative approach between orthodox and integrative medicine

Kenya/Brazil resolution focus of meeting

One of the most highly-publicized resolutions to be considered at this year's World Health Assembly concerns the report of the Commission on Intellectual Property Rights, Innovation, and Health (CIPIH). The Commission, chaired by former Swiss Federal President Ruth Dreifuss, was sponsored by the WHO in response to the concerns of developing nations that not enough is being done to research, develop, and fund treatments for "neglected" diseases that disproportionately affect the developing world; Briefly, the report suggests that the current system of patent protection for pharmaceuticals is not promoting the interests of health in the developing world and is not supporting research into diseases that disproportionately affect the developing world. Following the report, Kenya and Brazil have submitted a resolution calling for a "global framework on essential health research and development" which would call on the public sector to promote research into diseases that affect people in the developing world and put even more pressure on Western pharmaceutical companies.

Kenya and Brazil hosted a meeting to promote their resolution among delegates and others in attendance. Officials from the Kenyan Ministry of Health noted that 6 million people are at risk for sleeping sickness; several million more for river blindness, and far larger numbers for bilharzias and Chagas disease as well as malaria and HIV.

The meeting attracted a number of delegates and activists on both sides of the issue. Proponents such as a representative of Doctors Without Borders and Jamie Love of the Consumer Project on Technology joined the call for a "global framework" to discuss this issue in the context of the WHO, possibly leading to new proposals for the World Health Assembly or even a treaty on the issue. Love and others stated that neither the CIPIH report nor the resolution was directed against patents themselves and that the resolution should be non-controversial. Activists on the other side, such as Stephen Phillips of the International Policy Network, asked why governments should focus on this issue to the exclusion of other, low-cost health interventions (such as those described in the "Civil Society Report on Intellectual Property and Health" which his group sponsored with a number of market-oriented think tanks in the developing world. Jerry Norris of the Hudson Institute inquired why the numbers of morbidity given by the resolution's proponents differed from the WHO's own numbers (he was told that the WHO numbers were lagging indicators, yet he noted afterwards that if this were so, the number should be declining, not rising). The meeting also discussed the degree to which public-private partnerships (PPPs) were or were not addressing neglected diseases adequately, depending on the speaker's point of view.

May 24-25, 2006

Commision on Intellectual Property Rights, Innovation, and Health (CIPIH)

On Thursday, May 25, Committee A of the World Health Assembly began its consideration of the report of the Commission on Intellectual Property Rights, Innovation, and Health (CIPIH) and two associated resolutions proposed for consideration by the Assembly. On Wednesday afternoon, it was proposed to have a working group begin consideration of these matters before the full Committee had heard from Member States on the issue, but the proposal was defeated because Member States could not agree on the propriety of a working group beginning work before the Committee had begun to debate the issue and the remit of the working group even if the time was ripe to set one up.

Generally, Member States welcomed the CIPIH report and called for adoption of at least one of the resolutions. African and Latin American states that addressed the Committee broadly supported the Kenya/Brazil resolution; other states such as India and the Philippines noted the common ground in the two proposed resolutions and called on the committee to seek to merge them into one text.

South Africa began this morning's debate by stating that it understood the important role of innovation in public health and that companies were entitled to recoup their investment costs and make a "reasonable" profit, but that they have found instances in which the price for products "far exceeds" the cost of making them, which South Africa termed an "abuse of intellectual property rights." South Africa also noted that some companies ignore markets in developing countries but stated that it believes the volume of sales of these companies, products would rise if it did. South Africa stated it was concerned about "attempts by the pharmaceutical industry to influence this independent commission."

Kenya began its remarks by stating that "access to [health] products is the key to improving the health of people in developing countries." It supports a new framework of access to innovation, lest people in poor countries continue to die because of lack of access to these new drugs, noting what it termed the "urgent need for priorities-driven research." (The country did not, however, propose any specific guidelines for how the priorities would be determined, such as mortality rates, prevalence rates, or the likelihood of success of clinical trials). Kenya also noted that even HIV and tuberculosis can fall into the category of neglected diseases because of the lack of commercial possibilities in treating these diseases. Kenya declared that the resolution it has proposed "recognizes the importance of intellectual property rights" (IPR) but stated that it seeks a balance between those rights and access to drugs for people who cannot afford them. The country concluded by stating that its proposal for a new global "framework" did not connote a legally-binding obligation but rather efforts at "social solidarity" such as the WHO's "3x5" proposal to put 3,000,000 people on antiretroviral therapy for AIDS by 2005 (a target that was not met). (It is also worth noting that some countries and activists have proposed a new treaty on intellectual property rights and health, so while the Kenyan resolution is not legally-binding, some wish to go further.)

Austria, speaking in its capacity as President of the European Union, noted that under the Treaties defining the Union, the competence on these issues rightly belonged to the European Commission. It then asked that the Commission be given the right to speak out of turn, a change from the normal rule that interventions from intergovernmental organizations follow all those from sovereign states. The United States did not object, despite its past misgivings about strengthening the role of the Commission in international bodies in which the EU's Member States also hold seats. The Commission, speaking on behalf of its 25 members, Romania, Bulgaria, Croatia, Turkey, (the former Yugoslav Republic of) Macedonia, and Serbia and Montenegro, delivered a moderate position, stating that any resolution should focus on appropriate pricing and availability of drugs while taking account of IPR.

Tunisia called for "increasing transparency" on the prices of medicines and a "firm commitment" to pricing discounts from pharmaceutical companies, so that money could be channeled back into treating neglected diseases (with the implication that money would be transferred away from corporate profits).

India raised an issue discussed by many other participants -- the need for countries to take full advantage of the flexibility on patents and pricing given them by the World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement of 1995 and the Doha Ministerial Declaration of 2001, permitting countries to declare health emergencies and force compulsory licensing to produce generic versions of patented medicines.

Japan struck a different note, noting the dissenting views to the report in its annex such as those of Professor Hiroko Yamane highlighting the benefits of strong IPR regimes. Japan stated that the current patent system is working effectively and noted its belief that research on neglected diseases was not the most efficient use of health resources for many countries given other public health priorities.

Similarly, the United States noted the complex relationship between IPR and health. Given that development of new drugs is risky, it required incentives for the private sector, and IPR?s exist for this reason. The U.S. noted its concerns with areas where the report went beyond its mandate, particularly in addressing issues of human rights in this context. Canada noted that any ongoing working group should be time-limited rather than open-ended, as Brazil and Kenya have proposed.

Brazil announced that on Tuesday, a number of South American health ministers had entered a declaration regarding intellectual property and access to drugs for public health.

Norway called for the inclusion of NGOs and civil society in any ongoing working group established by a resolution on the CIPIH report and stated that the current incentive system needed to be reworked to take into account the needs of poor countries, it stated directly that "IPR is clearly not up to the challenge faced by poor countries."

Venezuela, Vietnam, Iran, and several other countries attacked the concept of "TRIPS +" agreements as part of bilateral Free Trade Agreements in which developing countries were asked to incorporate stronger IP provisions in areas such as patents and data exclusivity. No country, however, mentioned the United States by name, though these agreements form a feature of U.S. bilateral FTAs.

Cuba criticized the fact that 87% of patents and trademarks are held by transnational corporations. Sudan states that the contribution from the private sector to neglected diseases is very low and that public-private partnership had failed to increase funding from the private sector thus far (an assertion that would be hotly disputed by pharmaceutical companies).

Thailand proposed that a working group of Member States, chaired by Switzerland, be set up to try to reach some consensus on the various resolutions (The Chair of CIPIH was Ruth Dreifuss of Switzerland). These proposals were accepted, and the committee agreed to suspend discussion of this item pending the results of the working group.

Among the NGOs, Consumers International strongly supported the Kenya/Brazil resolution, stating that the "global community needs to address market failure and public goods, such as the Human Genome Project." (Consumers International also spoke on behalf of Medicins sans Frontieres (Doctors Without Borders), which has been active in supporting the Kenya/Brazil resolution) and of Health Action International, which has worked with WHO on ways to measure drug prices in Africa). Oxfam stated that "adverse health consequences" should be considered before countries adopt "TRIPS +" agreements.

In contrast, the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) noted the new program of research and development directed towards the needs of developing countries and the importance of public-private partnerships (PPPs) in addressing diseases that disproportionately affect the developing world. Of 63 new drug products for neglected diseases, 16 were developed by industry alone and 47 under PPPs. IFPMA also reminded the committee that industry researches diseases for other causes of morbidity such as HIV, cardiovascular diseases, and diabetes, and that IPR plays a vital role in promoting innovation in health care.

May 26-27, 2006

Progress on intellectual property Resolutions

A working group of interested Member States, chaired by Switzerland, has been meeting to try to make progress on reconciling the two resolutions on intellectual property and health put forward at the World Health Assembly (one proposed by a committee of the Executive Board chaired by Dr. Suwit Wibulproprasert of Thailand and the other, an amendment with much stronger language, proposed by Brazil and Kenya). Attendance at and participation in the Working Group was open only to Member States. A new draft resolution was sent to delegates and publicly released this Friday morning.

Notably, the preamble of the draft resolution now adds language "[r]ecognizing the importance of public/private partnerships devoted to the development of new essential drugs and research tools, but [the World Health Assembly is] concerned about the need for governments to set a needs-based priority agenda for health, and to provide political support and sustainable sources of funding for such initiatives [.]" This is evidently compromise includes language about public/private partnerships, which the pharmaceutical industry was pushing for as a way to acknowledge their efforts to assist in fighting diseases that disproportionately affect the developing world but also reflects the desire of many developing countries to promote a "needs-based priority agenda for health." "Needs-based priority agenda" is not further defined.

Language from the old resolution that "the exclusive rights conferred by patents can affect the price and availability of medicines and other health-care products" has been dropped in favor of language that the World Health Assembly is [c]oncerned about the impact of high prices of medicines on access to treatment," which does not distinguish between patent-protected and generic products (generic drugs can be priced quite high in the developing world as well, depending on part on the particulars of the price control regime and regulatory regime in each country). The resolution keeps old language "noting that intellectual property rights are an important incentive in the development of new medical technologies" and also "noting, however, that this incentive lacks efficacy for the development of new diseases where the potential paying market is small or uncertain [.]" Beyond its previous reference noting that the Trade-Related Aspects of Intellectual Property (TRIPS) Agreement permits nations to take "measures to protect public health and, in particular, to promote access to medicines for all," the new draft also adds from the Brazil/Kenya resolution a reference to Article 7 of the TRIPS Agreement, which states that "the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations." A new paragraph was also added "[s]tressing that the Universal Declaration of Human Rights provides that 'everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits' and that 'everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author [.]'"

In the operative paragraphs, the old language about ensuring that "bilateral trade agreements do not seek to incorporate TRIPS-plus protection in ways that may reduce access to medicine in developing countries" was removed in favor of milder, and now bracketed, language. Language has been added urging Member States "to make global health and medicines a strategic sector, to take determined action to emphasize priorities in research and development addressed to the needs of patients, especially those in resource-poor settings, and to harness collaborative research and development initiatives involving disease-endemic countries" and "to ensure that progress in basic science and biomedicine is translated into improved, safe and affordable health products -- drugs, vaccines, and diagnostics -- to respond to all patients' and clients' needs, especially those living in poverty[.]"

The new draft contains a provision establishing an intergovernmental working group open to all interested Member States "to develop a global strategy and plan of action to provide a medium term framework [to implement/build on] the recommendations of the Commission [taking into consideration WHO's comparative advantage." The bracketed text here and elsewhere in the draft resolution will still need to be negotiated by Member States before the resolution is adopted.

The working group would report to the World Health Assembly next year on progress in developing the global plan of action and then submit the final plan of action to the Assembly in 2008.

Vaccines as a public good?

During the debate over responding to avian influenza earlier this week, Thailand proposed an amendment stating that vaccines were a public good and providing that in the case of a human-to-human influenza pandemic, companies should not be able to commercialize any vaccines for avian influenza. The amendment was defeated; still, some observers noted that this was apparently the first time that the concept of vaccines as a public good had been discussed at an official international meeting. Research on avian/pandemic influenza vaccines for avian and human strains has been conducted since 1997.

Draft global strategy on sexually transmitted infectionss

Debate began Friday morning on the proposed draft global strategy on sexually transmitted infections (STIs) drafted by the WHO. Delegations other than the United States generally strongly supported the strategy. New Zealand began by proposing an amendment to clarify that references to "age-appropriate interventions" were not meant to imply that some interventions should not be given solely because of a person's age but rather, in the words of the amendment, to "recognize that age-appropriate interventions are those that respond to people's health and development needs and rights and provide access to sexual and reproductive health information, life skills education and services, and in the case of young people in a manner consistent with their evolving capacities." The amendment was supported by a number of countries, including Australia, Canada, the United Kingdom, Norway, Angola (speaking on behalf of the African WHO region) , Palau, and Samoa. Austria, speaking on behalf of the Member States of the European Union and candidate countries, supported the understanding of the strategy reflected in New Zealand's amendment but without specifically endorsing the amendment. Austria also commented that in the strategy as written, "'age-appropriate' has little to do with evidence-based responses and more to do with" the view that some persons should not receive certain services. Switzerland also endorsed the EU's position.

The United States, by contrast, praised many aspects of the strategy but with a far different emphasis. It commended the strategy for including sexual delay, abstinence, and partner reduction among its policies and for noting what the U.S. termed the "critical role of faith-based organizations" in addressing Sties. It noted President Bush's announcement of the New Partners Initiative, which will direct $200 million under the President's Emergency Plan for AIDS Relief to faith- and community-based organizations. In a direct rebuke to the WHO's usual language, the U.S. statement referred to "prostitutes, euphemistically called as sex workers" and noted that "prostitution is often involuntary, frequently resulting from domestic and international sex trafficking," tantamount to sexual slavery. The U.S. similarly noted that the strategy did not take into account rescue and rehabilitation for those trapped in involuntary prostitution. Further, the U.S. reiterated its view that the

International Conference on Population and Development did not establish new legal rights. Because the draft STI strategy is for countries to implement flexibility, the U.S. believes that the Assembly should not formally endorse the strategy and proposed an amendment that the resolution for the Assembly would "note" rather than "endorse it." Similarly, the U.S. confirmed its position, typical in international health and development conferences, that the term "reproductive health" and "reproductive health services" do not create any rights nor can they be construed to endorse abortion. The U.S. also proposed some other amendments reflecting language from the International Conference on Population and Development that "implementation is the sovereign right of each country . . . with full respect for the religious and cultural backgrounds of its people, in conformity with human rights."

The United Kingdom's intervention was notably harsh towards the United States, stating that the Assembly "should be concerned with evidence-based [approaches] and not with value-laden statements." Norway commented that "services should be provided not only on the basis of needs but also the adolescent's own rights," specifically referencing the Convention on the Rights of the Child.

Another interesting point is that both Gambia and Swaziland thanked "the government and people of Taiwan" for assistance in working against the spread of sexually transmitted infections. Taiwan is not a Member State of the WHO, and an attempt to give it observer status was once again defeated on Monday.

Because of the amendments presented, a small working group began consideration of how to proceed.

Latin American declaration on intellectual property and access to medecines

On Tuesday in Geneva, health ministers from Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Paraguay, Peru, Uruguay, and Venezuela signed a "Declaration of Ministers of South America over Intellectual Property, Access to Medicines and Public Health." Quotations below are from an unofficial translation.

The preamble states that "Access to medicines and critical raw materials is an integral part of the right of health" and further states that "significant price increases" for pharmaceuticals in both the government and private sectors are "a consequence of the patent system" and leads to "a deterioration of access to essential drugs." The Ministers declared their commitment to promote the implementation of the Doha Declaration on Intellectual Property Rights and Public Health in their countries, in relation to "granting of compulsory licenses and the use of parallel importing mechanisms." Further, the Ministers also agreed, among other items, to maintain the flexibilities provided in the TRIPs agreement in bilateral and regional arrangements, facilitate the use of compulsory licenses and parallel importing, avoiding broadening the scope of patentability and to "[seek] the actual role of our Ministries of Health in the negotiation of bilateral trade agreements, in the negotiation among regional groups as well as in the process of modification, updating and consolidation of national intellectual property rights norms[.]"

If this statement represents the settled policies of the governments concerned, this will likely have an impact with respect to the negotiation of bilateral free trade agreements in Latin America with the United States as well as the eventual negotiations towards a Free Trade Agreement of the Americas. The United States has taken a position in favor of so-called "TRIPS plus" provisions in bilateral trade agreements which maintain greater protection for intellectual property rights in certain contexts, such as prohibiting parallel importation and compulsory licensing.