An indigenous peasant farmer holds native coffee grains he grows in the southern Mexican state of Chiapas. The sharing of benefits generated by genetic resources has become a controversial issue throughout Latin America. Credit: Emilio Godoy/IPS

By Emilio Godoy
MEXICO CITY, Aug 22 2016 (IPS)

In July 2015, the Mexican government granted a U.S. corporation permission for the use of genetic material obtained in Mexican territory for commercial and non-commercial purposes, in one of the cases that has fuelled concern in Latin America about the profit-oriented approach to biodiversity.

The agreement, which is catalogued with the identifier number Absch-Ircc-Mx-207343-2, was approved by the National Seeds Inspection and Certification Service and benefits the U.S. company Bion2 Inc, about which very little is known.

Prior, informed consent from the organisation or individual who holds right of access to the material was purportedly secured. But the file conceals the identity of this rights-holder and of the genetic material that was obtained, because the information is confidential.

This is an example of confidentiality practices that give rise to concern about the proper enforcement of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, signed in that Japanese city in 2010 and in effect since 2014.

The protocol, a supplementary agreement to the 1992 Convention on Biological Diversity, in force since 1993, seeks to strengthen the conservation and sustainable use of biodiversity and the fair and equitable sharing of benefits arising from the utilisation of genetic resources.

In Latin America and the Caribbean, the protocol has been ratified by Cuba, the Dominican Republic, Guatemala, Guyana, Honduras, Mexico, Panama, Peru and Uruguay.

The protocol stipulates that each party state must adopt measures to ensure access to traditional knowledge associated with genetic resources in the possession of indigenous and local communities.

That will be done, it states, through the prior informed consent and the approval and participation of these groups, and the establishment of mutually agreed conditions.

“The expectations of indigenous people are not well-covered by the protocol,” Lily Rodríguez, a researcher with the Institute for Food and Resource Economics at Germany’s Bonn University, told IPS.

She stressed that the protocol is “the opportunity to recognise traditional knowledge as part of each nation’s heritage and to establish mechanisms to respect their decisions with regard to whether or not they want to share their knowledge.”

Latin America and the Caribbean is the region with the greatest biodiversity in the world, as it is home to several mega-diverse countries like Brazil, Colombia, Ecuador and Mexico.

The questions covered by the Nagoya Protocol will form part of the debate at the 13th meeting of the Conference of the Parties to the Convention on Biological Diversity, to be held December 4-17 in Cancun, Mexico.

Indigenous groups and civil society organisations complain that the protocol recognises intellectual property rights for so-called bioprospectors, research centres or companies hunting for biological information to capitalise on.

Quechua peasant farmers plant quinoa seeds in Peru’s highlands. Civil society organisations and indigenous peoples are strongly opposed to the commercial use of Latin America’s genetic wealth. Credit: Courtesy of Biodiversity International

Furthermore, the sharing of eventual monetary and non-monetary benefits for indigenous peoples and communities is based on “mutually agreed terms” reached in contracts with companies and researchers, which can put native people at a disadvantage.

In Guatemala, civil society organisations and indigenous groups have fought their country’s inclusion in the Nagoya Protocol, which it signed in 2014.

In June, a provisional Constitutional Court ruling suspended the protocol in Guatemala.

“We are opposed because it was approved without the necessary number of votes in Congress; indigenous people were not consulted; and it gives permission for experimentation with and the transfer and consumption of transgenics,” said Rolando Lemus, the head of the Guatemalan umbrella group National Network for the Defence of Food Sovereignty.

The activist, whose NGO emerged in 2004 and which groups some 60 local organisations, told IPS, from the Guatemalan department of Chimaltenango, that the use of biodiversity is part of the culture and daily life of indigenous people, whose worldview “does not allow profiting from ancestral know-how.”

Guatemala had accepted three requests for research using the medicinal plant b’aqche’ (Eupatorium semialatum), cedar and mahogany. The request for the first, used against stomach problems like worms, was in the process of being studied, and the other two were approved in October 2015 for research by the private University del Valle of Guatemala.

As a subsidiary to the Biodiversity Convention, the protocol also covers activities carried out since last decade, regulated by national laws, in different countries of Latin America, which are discussed in a regional study published in 2014.

Brazil, for example, has granted at least 1,000 permits for non-commercial research since 2003 and 90 for commercial research since 2000.

Between 2000 and 2005, Bolivia granted 10 genetic resources access contracts, out of 60 requests filed. Several of them involved quinoa and other Andes highlands crops.

Two of them were for commercial uses. But since new laws were passed in Bolivia in 2010, ecosystems and the processes that sustain them cannot be treated as commodities and cannot become private property. The legislation amounts to a curb on the country’s adherence to the protocol.

In Colombia there are permits to collect samples and to send material abroad. Since 2003, that South American country has granted 90 contracts, out of 199 requests, and has signed a contract for commercial research.

Although Costa Rica has not approved permits for access to traditional knowledge or genetic resources in indigenous territories, it has issued 301 permits for basic research and access to genetic resources and 49 for bioprospecting and access to genetic resources since 2004.

Bioprospecting involves the systematic search for, classification of, and research into new elements in genetic material with economic value. The role of the protocol is to ensure that this does not deprive the original guardians of their knowledge and eventual benefits.

Ecuador has received 19 requests since 2011 and in 2013 it negotiated a commercial contract.

For its part, Mexico has authorised 4,238 permits for scientific collection since 1996, and only a small percentage of requests have been denied.

Peru, meanwhile, requires a contract for every kind of access. Since 2009, it has authorised 10 contracts, out of more than 30 requests, and 180 permits for research into biological resources.

Ecuador is a good example in the region of the plunder of genetic material, as officials in that country complain.

The “First report on biopiracy in Ecuador”, released in June by the Secretariat of Higher Education, Science, Technology and Innovation, stated that Australia, Belgium, France, Germany, Israel, the Netherlands, South Korea, the United Kingdom and the United States have improperly exploited their biological wealth.

Of 128 identified patents, companies from the U.S. hold 35, from Germany 33, from the Netherlands 17, from Australia 15 and the rest are held by firms in a number of countries.

“It all depends on how the governments of each country protect indigenous people, in accordance with their own legal frameworks,” said Rodríguez.

“If the legislation says that they will only negotiate prior consent, including clauses on mutually agreed conditions – if they aren’t in a position to negotiate, it would be good if the government supported them so the negotiations would be more equitable and favourable for native peoples,” she argued.

Lemus is confident that the suspension in Guatemala will remain in place. “We are thinking of other actions to engage in. People must have mechanisms to protect themselves from intellectual property claims and genetic contamination,” he said.

By Carlos M. Correa
GENEVA, Oct 15 2015 (IPS)

The pharmaceutical industry from the US and Europe scored a major victory with the adoption, in 1994, of a binding agreement on intellectual property (Agreement on Trade Related Aspects of Intellectual Property Rights – TRIPS) in the context of the nascent World Trade Organization (WTO).

While some transitional periods were allowed, the TRIPS Agreement did not leave any space for a special and differential treatment based on the countries’ levels of development. In particular, it imposed on all World Trade Organisation members (WTO) the obligation to grant patents in all fields of technology.

The lack of patent protection promotes price competition in the pharmaceutical market and, in some cases, clears the way for the development of generic pharmaceutical industries. The most noticeable case is that of India, which developed a strong pharmaceutical industry and is known today as “the pharmacy of the developing world.”

The Trans-Pacific Partnership (TPP) is an ambitious trade agreement between the U.S. with 11 other countries (Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam).

Notably, there are major differences in the level of development of these countries (for example, Vietnam’s gross domestic product per capita (GDP) is approximately 43 times less than the US GDP per capita). Despite this, Washington seeks the application of the same standards of protection to all parties in the partnership.

In fact, tariffs are already low among the TPP negotiating countries. There are very little gains to be obtained from the TPP in this regard.

What these agreements tend to be really about are issues such as intellectual property rights. And the most important strategic reason of this initiative for the US is likely to be to counter China’s growing influence in the Asia-Pacific region, and to make the region less hospitable for the Chinese “state capitalism.”

The enhanced protection of pharmaceutical products was a key concern for the US in trade negotiations that led to the adoption of the TRIPS agreement. Despite the significant enhancement of the international standards of intellectual property protection that that agreement entailed, the pharmaceutical industry from the US and the European Union remained unsatisfied. They aimed at even higher standards of protection.

However, it soon became evident that it would not be possible to obtain such higher standards within the relevant multilateral organizations, WTO and World Intellectual Property Organisation (WIPO), where developing countries resisted further increases in intellectual property protections.

In this scenario, developed countries opted to seek the enhanced protection demanded by the pharmaceutical industry and other constituencies through bilateral or plurilateral trade agreements, where the bargaining position of individual countries is weaker and the promises of market access, or other real or expected trade advantages, make agreements of intellectual property more viable.

Thus, while under the TRIPS Agreement patents must last for 20 years from the date of application, the free trade agreements (FTAs) promoted by the US oblige the partner signatory countries to extend the patent term to compensate for “unreasonable” delays beyond a certain period in the procedures for the marketing approval of a medicine as well as in the examination and grant of patent applications.

FTAs also oblige, among other things, to grant patents based on “utility” rather than industrial applicability and, importantly, to secure market exclusivity on the basis of the protection of test data required for the marketing approval of pharmaceuticals, generally for five years from the date of such approval in the country where protection is sought. FTAs also require partners to establish a “linkage” between the marketing approval of medicines and patents, thereby granting pharmaceutical companies with rights that, under some FTAs, are also stronger than those available under the US law.

For instance, a study found that the patent term extension would generate in Colombia an increase in pharmaceutical expenditures of US$ 329 million and a reduction in pharmaceutical consumption of 7 per cent by 2025.

With respect to the potential impact of the TPP, in particular, a study by Australian and US researchers estimated that, in Vietnam, the government would only be able to provide anti-retroviral therapy to 30 per cent of people in living with HIV (down from its current rate of 68 per cent) since the cost per person per year of treatment would increase to US$ 501 under the US proposal from its current level of $127.22.

The negative impact of TRIPS-plus standards on access to medicines has been found even in developed countries that are not net exporters of intellectual property rights, such as in Canada and Australia.

The costs incurred by the smaller partners in FTAs are disproportionately high in relation to the benefits that accrue to pharmaceutical companies.

(End)

Excerpt:

Zambian cotton grower sitting on his bales. Some African governments and local cotton producers have high hopes that GM technology will boost African competitiveness in the dog-eat-dog world that characterises the global cotton market. Credit: Nebert Mulenga/IPS

By Haidee Swanby
MELVILLE, South Africa, Jun 15 2015 (IPS)

Genetically modified (GM) cotton has been produced globally for almost two decades, yet to date only three African countries have grown GM cotton on a commercial basis – South Africa, Burkina Faso and Sudan.

African governments have been sceptical of genetically modified organisms (GMOs) for decades and have played a key role historically in ensuring that international law – the Cartagena Protocol on Biosafety – takes a precautionary stance towards genetic engineering in food and agriculture.

They have also imposed various restrictions and bans on the cultivation and importation of GMOs, including on genetically modified (GM) food aid.

But now resistance to GM cultivation is crumbling as a number of other African countries such as Malawi, Ghana, Swaziland and Cameroon appear to be on the verge of allowing their first cultivation of GM cotton, with Nigeria and Ethiopia planning to follow suit in the next two to three years.“Scrutiny of actual experiences [with GM cotton] reveals a tragic tale of crippling debt, appalling market prices and a technology prone to failure in the absence of very specific and onerous management techniques, which are not suited to smallholder production”

Some African governments and local cotton producers have high hopes that GM technology will boost African competitiveness in the dog-eat-dog world that characterises the global cotton market.

At the moment African cotton productivity is declining – it now stands at only half the world average – while global productivity is increasing. The promise of improving productivity and reducing pesticide use through the adoption of GM cotton is thus compelling.

However, African leaders and cotton producers need to take a close look at how GM cotton has fared in South Africa and Burkina Faso to date, particularly its socioeconomic impact on smallholder farmers.

Scrutiny of actual experiences reveals a tragic tale of crippling debt, appalling market prices and a technology prone to failure in the absence of very specific and onerous management techniques, which are not suited to smallholder production.

As stated by a farmer during a Malian public consultation on GMOs, “What’s the point of encouraging us to increase yields with GMOs when we can’t get a decent price for what we already produce?”

In Burkina Faso, the tide turned against GM cotton after just five seasons as low yields and low quality fibres persisted. In South Africa, GM cotton brought devastating debts to smallholders and the local credit institution went bust. Last season, smallholders contributed to less than three percent of South Africa’s total production.

In Malawi, Monsanto has already applied to the government for a permit to commercialise Bollgard II, its GM pest resistant cotton, to which there has been a strong reaction from civil society and an alliance of organisations has submitted substantive objections.

Even Malawi’s cotton industry, the Cotton Development Trust (CDT), has publically voiced its concerns over a number of issues, including inadequate field trials, the high cost of GM seed and related inputs, and blurred intellectual property arrangements.

In addition, CDT has expressed unease over the potential development of pest resistance and the inevitable applications of herbicide chemicals.

Regional economic communities (RECs), such as the Common Market for East and Southern Africa (COMESA) and the Economic Community for West African States (ECOWAS), are also key players in readying their member states for the commercialisation of and trade in GM cotton, through harmonised biosafety policies. Together COMESA and ECOWAS incorporate 34 countries in Africa.

The COMESA Policy on Biotechnology and Biosafety was adopted in February 2014 and member states validated the implementation plan in March 2015.

The ECOWAS Biosafety Policy has been through an arduous process for more than a decade now and pronounced conflicts between trade imperatives and safety checks have stalled agreement between stakeholders. However, recent reports indicate that agreement between member states and donor parties has been reached and a final draft of the Biosafety Policy will soon be published.

Experiments and open field trials with GM cotton have been running for many years in a number of African countries and are increasingly at a stage where applications for commercial release are imminent.

However, there are many obstacles to the birth of a new GM era in Africa, chief among them the fact that this high-end technology is simply not appropriate to resource-poor farmers operating on tiny pieces of land, together with fierce opposition from civil society and sometimes also from governments.

Attempts by the biotech industry to impose policies that pander to investors’ desires at the expense of environmental and human safety may be easier to realise at the regional level, through the trade-friendly RECs. This is where many biotech industry resources and efforts are currently being channelled.

Despite whatever legal environments may be implemented to enable the introduction of GM cotton regionally or nationally, the fact remains that Africa’s cotton farmers are operating in a difficult global sector – prices are erratic and distorted by unfair subsidies in the North, institutional support for their activities is often lacking, and high input costs are already annihilating profit margins.

Fighting for the introduction of more expensive technologies that have already proven themselves technologically unsound in a smallholder environment is deeply irresponsible and short-sighted.

It is time that African governments turn their resources to improving the local environments in which cotton producers operate, including institutional and infrastructural support that can bring long-term sustainability to the sector, without placing further burdens and vulnerability on some of the most marginalised people in the world.

Civil society actions will continue to vehemently oppose and challenge the false solutions promised by GM cotton and will insist on just trading environments and true and sustainable upliftment for African cotton producers.

Edited by Phil Harris   

The views expressed in this article are those of the author and do not necessarily represent the views of, and should not be attributed to, IPS – Inter Press Service. 

* This opinion piece is based on the author’s more extensive paper titled Cottoning on to the Lie, published by the African Centre for Biodiversity, June 2015

Excerpt:

Patient and leading health organisations in South Africa have now joined a Fix the Patent Laws campaign launched in 2011 by Treatment Action Campaign (TAC) and Doctors Without Borders (MSF) to push for reform of the country’s current patent laws.

The campaign’s promoters say that these laws severely restrict access to affordable medicines for all people living in South Africa.

The organisations which have adhered to the campaign are: People Living With Cancer (PLWC), South African Depression and Anxiety Group (SADAG), DiabetesSA, CanSurvive, SA Federation for Mental Health (SAFMH), Stop Stock Outs, Cancer Association of Southern Africa (CANSA), Schizophrenia and Bipolar Disorder Alliance (SABDA), South African Non-Communicable Diseases Alliance (SANCD Alliance), Marie Stopes, Epilepsy South Africa and Cape Mental Health.

Together, they are calling on the South African government to finalise a National Policy on Intellectual Property that champions measures to reduce prices and increase access to a wide range of medicines for people in need across the country.

TAC and MSF reported Jun. 1 that the expanded coalition of organisations represents public and private sector patients in South Africa seeking treatment and care for a range of cancers, mental illnesses, diabetes and other non-communicable diseases – as well as tuberculosis, HIV and sexual and reproductive health diseases.

South Africa currently grants patents on almost every patent application it receives, allowing companies to maintain lengthy monopoly periods on medicines, argues the campaign. This keeps prices of many medicines higher in South Africa than in many other countries.

According to TAC and MSF, it is estimated that 80 percent of patents granted in South Africa do not meet the country’s patentability criteria. This is largely due to the fact that patents are granted without substantive examination of applications to ensure that patentability criteria are met.

“Some cancer patients would rather go to other countries, like India, for treatment – the combined cost of the flight, medical services and drugs is cheaper than buying the drugs alone in South Africa,” said Bernice Lass of cancer group, CanSurvive.

Linda Greeff of PLWC said that her organisation was supporting the campaign because “we want to ensure that there is proper scrutiny of patent applications before patents are granted. We want a patent granting process that is ethical and transparent, so that more people can access the medicines that they need.”

According to Cassey Chambers of SADAG, the group deals with “patients every day who cannot afford medication or treatment, and as a result become more depressed, helpless, hopeless and even suicidal in some cases.”

DiabetesSA’s Keegan Hall stressed that as health organisations, “we have an obligation to take steps to improve affordability and access to medicines. The cost of insulin and other diabetes management tools are far too expensive for many patients,” Hall added.

Health organisations joining the Fix the Patent Laws campaign say that they recognise the opportunity South Africa has to improve access to medicines for all diseases through reforming problematic patent laws.

South Africa’s Department of Trade and Industry (DTI) has already embarked on the process of legislative reform, releasing a Draft National Policy on Intellectual Property for public comment in 2013. The draft policy contained important commitments to reform the laws in order to restore the balance between public and private interest, in favour of people’s health.

The Fix the Patent Laws campaign coalition is calling for urgent approval of a finalised National Policy on Intellectual Property, as a critical first step toward reform of problematic patent laws and practices that deprive people living in South Africa of more affordable treatments for all conditions.

It notes that as a member of the World Trade Organisation (WTO), South Africa is required to uphold minimum standards of intellectual property protection as defined by the international Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). This includes granting 20-year patents on medicines.

However, South Africa also has significant flexibility under TRIPS to amend national legislation in order to improve access to medicines. According to the health organisations, reforms could include the government taking measures to limit abusive patents being granted on medicines.

At the same time, it says, government could establish easier procedures for overcoming legitimate patent barriers when medicines are unaffordable, unavailable or not adapted for patient needs.

Edited by Phil Harris   

By Carlos M. Correa
GENEVA, Feb 3 2015 (IPS)

Industry’s demands and political pressures exerted by developed countries to expand and strengthen patent protection worldwide have been based on the argument that patents promote innovation and thereby contribute to achieve social, political and economic well-being, independently of the level of development of the country where they are granted and enforced.

This view ignores the fact that patents do not have the same impact in countries with different industrial bases, research and development (R&D) capabilities and availability of capital to finance innovation, among others.

Carlos M. Correa

Significantly, there is a growing body of academic studies challenging the belief that patents are essential to incentivise innovation, even in advanced countries, or to enhance economic growth.

While many scholars call for a substantial reform of the patent system, others go as far as suggesting its abolition.

In a working paper entitled The case against patents, Michele Boldrin and David K. Levine have argued that “in spite of the enormous increase in the number of patents and in the strength of their legal protection we have neither seen a dramatic acceleration in the rate of technological progress nor a major increase in the levels of research and development (R&D) expenditure. There is strong evidence, instead, that patents have many negative consequences.”

“Both of these observations are consistent with theories of innovation that emphasise competition and first-mover advantage as the main drivers of innovation and directly contradict theories postulating that government-granted monopolies are crucial in order to provide incentives for innovation.”

The role of the patent system is thus controversial, particularly in developing countries.“Patents do not have the same impact in countries with different industrial bases, research and development (R&D) capabilities and availability of capital to finance innovation, among others”

In the last 25 years, much emphasis has been put on the concept of intellectual property as ‘truly property’. Different variants of natural rights-based approaches have been articulated to justify developed countries’ relentless efforts to increase the scope and levels of intellectual property protection, notably for patents.

The idea that patents are a piece of property has provided ideological support for an expansion of the protectable subject matter, the extension of the term of protection, the reinforcement of the exclusive rights, and the strengthening of enforcement measures.

Patents confer exclusive rights. They limit the use of knowledge – a public good by its very nature – and competition, which promotes consumer well-being and innovation.

Nobody can produce or commercialise the protected invention during the lifetime of the patent, unless authorised by the patent holder or under compulsory licences, which are rarely granted. Given the exclusionary effects of patents, they have often been characterised as ‘monopolies’.

Yet, the rights conferred by patents are based on partial and often imperfect factual determinations. The examination process does not allow patent offices to reach definitive
judgments on patentability.

There is also uncertainty regarding the validity of patents in the boundaries of what is protected under individual patents. The patent claims are in many cases ambiguous and it is unclear what the actually protected subject matter is. Australian academic Peter Drahos asserts that “patents, unlike blocks of land, do not come with settled boundaries.”

Thus, it is fuzziness rather than definitiveness that characterises patent grants. This is not accidental, but deliberately sought by patent applicants to discourage competitors.

In addition to imprecise disclosures of what is deemed to be the invention, courts interpret patent claims with different theories and methodologies that lead to diverse outcomes with regard to what is deemed protected and eventually infringed.

Another fundamental problem with the patent regime is that it operates on the basis of a limited capacity to examine the patentability of claimed inventions and on a number of legal fictions created by legislators, patent offices or courts.

Such legal fictions are often dogmatically applied, without a critical assessment of their justification and implications.

A patent is granted in most countries after a substantive examination is conducted to determine whether it meets the patentability standard established by national laws which generally require novelty, inventive step (or non-obviousness) and industrial applicability (or utility).

However, some countries (such as Luxembourg and South Africa) confer patents without such a substantive examination or without assessing inventive step (for example, Switzerland and France).

While patent offices in developing countries (except China) receive a number of patent applications much lower than developed countries, some (such as Argentina, India and Thailand) have introduced legislative or other regulatory changes to tighten the application of the patentability requirements and reduce, through a rigorous examination, the proliferation of patents, particularly in the pharmaceutical field.

The intervention of patent offices through substantive examination in the process of creating patent rights gives them an appearance of validity. However, such intervention offers no guarantee in this respect and the public and uninformed business actors may be grossly misled.

The case of South Africa, where no substantive examination is currently made, is illustrative.

Thousands of patents have been registered in South Africa to cover minor or trivial developments that can block local production or importation of lower-priced generic medicines. However, the government of South Africa recently announced its intention to introduce a system of substantive examination, at least for pharmaceutical patents.

This proposal raised stiff opposition from pharmaceutical multinational companies, which were eventually found to finance a covered lobbying operation aimed at derailing the government’s initiative.

On the one hand, it is to be expected that the introduction of such a system would discourage patent applications that may not survive a serious substantive analysis; hence, the number of applications will presumably diminish over time, especially if fees are established at a level that discourages speculative patenting.

On the other, the available information on patent offices in other developing countries suggests that the number of examiners required to review pharmaceutical patent applications is manageable for South Africa even if it opted to rely on internal examiners only.

Unfortunately, many patent offices have tended to work under the assumption that their role is to grant as many patents as possible, and to decide in favour of the applicant in case of doubt. Applicants are often treated as ‘clients’.

As noted by Dominique Foray, patent offices have become extremely pro-patent since the early 1980s. The applicant, formerly considered with suspicion, has become a ‘client’ whose needs must be satisfied by quick, cheap procedures. The result is a total deterioration of examination procedures.

The patent office should function as a steward of the public interest, not as a servant of patent applicants and must protect the public against the issuance of invalid patents that add unnecessary costs and may confer market power. (END/IPS COLUMNIST SERVICE)

Edited by Phil Harris    

The views expressed in this article are those of the author and do not necessarily represent the views of, and should not be attributed to, IPS – Inter Press Service. 

* This column is based on South Centre Research Paper No 58 of December 2014. A full version of the paper is available here.

Excerpt:

Patented drugs limit patients’ access to public health care. Credit: Kristin Palitza/IPS

By Emilio Godoy
MEXICO CITY, Oct 8 2013 (IPS)

The Trans Pacific Partnership Agreement (TPP), the negotiation of which is set to conclude this year, could drive research into new drugs and improve access to medicines. Except – it won’t.

“The current health system is reaching its limit,” Judit Rius, manager of Médecins Sans Frontières/Doctors Without Borders Access Campaign in the United States, told IPS. “It is failing patients with rare diseases, for example.”

“That’s why the TPP could be a tool for promoting health and improving innovation and access, instead of fostering failed, costly systems based on monopolistic patents,” she added.

The TPP free trade accord went into force between Brunei, Chile, New Zealand and Singapore in January 2006. Eight other countries are now negotiating their incorporation: Australia, Canada, Japan, Malaysia, Mexico, Peru, the United States and Vietnam.
Of the 29 chapters under negotiation, the ones on intellectual property, investment and government procurement contain proposals, especially from the United States, to limit research and development of generic medicines, which are sold with the name of the active ingredient and can be produced once the patent for the original brand-name drug has expired.

Because they are less expensive, generic drugs are essential in the fight against disease, especially in poor developing countries.

The TPP talks have been shrouded in secrecy. But Rius said the aspects of the TPP that have been leaked to the press would hinder R&D in generic medicines, hurting the reduction of prices that has been achieved in recent years.

“Most affected by this would be patients, organisations that supply medicines, health and economy ministries, developing countries, and companies that produce generic medicines,” she said.

These laboratories are worried.

“The TPP could lead to the extension of patents and could hamper access to medicines,” José Luis Cárdenas, a lawyer who is an adviser to the board of Chile’s Industrial Association of Pharmaceutical Laboratories (ASILFA), told IPS.

“It is not realistic to think that developing countries are going to invest in R&D to produce new molecules,” given the investment capacity of multinational corporations, he said.

The 19th round of negotiations for the TPP took place in Brunei Aug. 23-30. Since then, the talks are no longer general but thematic. There are 21 working groups negotiating the 29 chapters, which include issues like agriculture, intellectual property, environment, services, telecommunications and investment.

Pharmaceutical patents give 20 years of protection, according to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) adopted in 1994 during the creation of the World Trade Organisation (WTO).

But the WTO’s 2001 Doha Declaration on the TRIPS Agreement and Public Health reaffirmed the flexibility of TRIPS member states in circumventing patent rights for better access to essential medicines. Under this declaration, governments may issue compulsory licenses on patents for medicines, or take other steps to protect public health.

Compulsory licensing is when a government allows someone else to produce a patented product without consent from the patent owner.

Washington wants the TPP to extend the length of chemical drug patent monopolies by five years and of biologics – products that includes a number of lifesaving drugs used to treat conditions such as cancer, diabetes and hepatitis C – by 12 years.

It is also pushing for data exclusivity, which gives companies monopoly rights over drugs by restricting the use of clinical trial data by drug regulators when approving generic or bioequivalent versions of drugs. This would keep the laboratories that make generic drugs from putting their products on the market as soon as patents expire.

In addition, it is pushing for the controversial practice of “evergreening” – the name given to the industry practice of seeking new patents after making small modifications to existing drugs.

Other measures on the table are patents for diagnostic, therapeutic and clinical procedures and the creation of a supranational mechanism to settle disputes between states and corporations.

These initiatives “affect access to medicine by the most disadvantaged segments of Mexican society due to the implications for the quality, safety and effectiveness of pharmaceutical products,” Gustavo Alcaraz, of Mexico’s National Association of Drug Manufacturers (ANAFAM), told IPS.

Alcaraz forms part of the Cuarto de Junto, a group of business delegates allowed by the economy ministry to monitor the negotiations without taking notes, after they sign a confidentiality agreement.

The secrecy surrounding the talks has kept civil society, academia, or health consumers from expressing their viewpoints on what is being negotiated.

Médecins Sans Frontières has called on the participating governments not to sign any agreement that undermines public health.

In 2011, non-governmental organisations and academics urged United Nations Special Rapporteur on the right to health Anand Grover to issue an urgent appeal to the governments involved in the TPP talks, on the grounds that the trade deal would severely impact the public health of the poor in developing nations.

In response, Grover sent a letter to the national authorities. But only Australia, Chile and New Zealand answered, defending the secrecy around the talks and voicing assurances that the right to health would be respected.

The effects of overzealous protection of intellectual property in health have been studied.

An article published in 2009 by the Health Affairs journal states that “Our study suggests that CAFTA (Central America Free Trade Agreement)’s intellectual property rules on data exclusivity and patents are responsible for the removal of several lower-cost generic drugs from the market in Guatemala and for the denial of entry to a number of others.”

And as a result of the U.S.-Jordan free trade treaty, “Medicine prices in Jordan have increased 20 percent since 2001,” according to a report published by Oxfam in 2007.

“Higher medicine prices are now threatening the financial sustainability of government public health programmes,” added the report.

The details of the agreement are on the table at the annual Asia Pacific Economic Cooperation (APEC) Forum Summit, taking place Oct. 7-8 in Bali.

After a TPP meeting on intellectual property in Mexico City Sept. 23-Oct. 2, the United States and Japan are now considering proposing that the extension of patent terms only apply to developed countries, allowing shorter periods in developing nations like Malaysia and Vietnam.