By Jomo Kwame Sundaram
ROME, Dec 11 2015 (IPS)

The latest estimates are that over two billion people in the world suffer some micronutrient deficiencies, often referred to as “hidden hunger.” The main sustainable solution is to ensure adequate public health interventions, including clean water, sanitation and hygiene as well as healthy, diverse diets for all.

Jomo Kwame Sundaram. Credit: FAO

In the short term, however, it will be necessary to provide supplements of vitamins, minerals and trace elements to those especially vulnerable, e.g. due to displacement and emergency situations. There is a general consensus that such needs of pregnant and lactating mothers should be especially prioritized due to the intergenerational consequences of child stunting for such reasons.

Developing countries should be able to affordably access locally produced or imported generics of the vitamin and mineral supplements they require. Many current options associated with public-private partnership will instead strengthen the vested interests of the lucrative, large and fast-growing industry for nutrition supplements.

The need for supplementation to address urgent, short-term micronutrient deficiencies should qualify as part of the public health exception to the Trade-Related Aspects of Intellectual Property Rights (TRIPs) rules of the World Trade Organization (WTO). This has not been fully recognized ostensibly because people do not drop dead immediately due to “hidden hunger.”

TRIPS and generics production for developing countries

Under the TRIPS agreement, intellectual property rights (IPRs) — for copyright, trademark, geographical indication, industrial designs and patents — are extended to all signatory countries. Patents, most relevant to public health and access to medicines, give twenty years of protection to inventions.

In the current language, there are no explicit provisions for generic production of patented nutrition supplements. However, there is supposed to be a great deal of flexibility on the basis of public health needs, which could be extended to minerals and vitamins for supplementation.

The TRIPS Agreement provides space for countries taking measures to protect public health. Under Article 31, countries can issue compulsory licenses allowing firms or individuals to produce generic copies of patented products or processes for the domestic market without the owner’s consent in “case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use.” The government can also determine adequate payment to the IPR holder.

At the Doha WTO conference in 2001 launching the Doha Development Round of trade negotiations, the Declaration on the TRIPS Agreement and Public Health affirmed the right of countries to protect public health, enable access to medicines, and determine the criteria for issuing a compulsory license. It emphasized that each country “has the right to grant compulsory licenses” and “the right to determine what constitutes a national health emergency or other circumstances of extreme urgency.”

This new text corrected the false impression that some health emergency was needed to justify compulsory licensing. It also spelt out that “public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.”

Technology transfer

Under Article 66.2 of TRIPS, developed country governments are obliged to actively promote technology transfer in establishing manufacturing capabilities for patented processes in developing countries. The 2001 Declaration also reaffirmed the developed countries’ commitment to provide incentives to their corporations to enable technology transfer to the least developed countries. This was part of the original bargain for developing countries to provide protection of IPRs.

Developing countries also have the right to import generics if they lack manufacturing capabilities. A 2003 waiver allows countries unable to domestically produce pharmaceuticals to import them instead. Hence, under compulsory licensing, such countries can import externally produced patented drugs. Thus, while compulsory licensing allows countries to import cheaper generics from countries already producing them, to take advantage of TRIPS Agreement flexibility, countries need to legislate accordingly.

However, exemptions to pharmaceutical patent protection to the least developed countries, enabling them to import without issuing a compulsory license, were only extended until 2016. The upcoming Nairobi WTO ministerial should extend this exemption beyond next year.

While there appears to be legal space under TRIPS for developing countries to use compulsory licensing, they have effectively be prevented from doing this by complicated rules and procedural requirements. Consequently, use of compulsory licensing by developing countries has been largely limited to HIV/AIDS medicines, and almost exclusively used by middle-income countries. LDCs have not issued any compulsory licenses while the total number of applications has declined significantly in the last decade.

Needed actions

Existing TRIPS texts do not preclude compulsory licensing for local generic production in developing countries. However, extension of the right to use compulsory licensing and other such flexibilities to vitamin and mineral supplements is not explicit. While explicit permission is given to AIDs, malaria, tuberculosis and epidemics, even this is rarely used.

In light of the foregoing, the following revisions to WTO provisions to protect developing countries’ right to produce generic vitamin and mineral supplements should be introduced. This will also be in line with the July 2015 Addis Ababa Action Agenda’s commitment to facilitate technology transfer:

• Developing appropriate model legislation to facilitate development of the national legislation needed for compulsory licensing, etc.
• Provide free legal services to developing country governments interested in accessing TRIPS facilities.
• Identify and investigate relevant national vitamin and mineral supplement production needs in partnership with other governments to enable developed countries to meet their technology transfer obligations.

Developing countries need to act to overcome three major constraints to issuing compulsory licenses and bypassing patent legislation for public health. First, the governments must be strong enough to withstand business and political pressures. Second, it is necessary to have enabling legislation in place. Third, these countries need to have production capacity and distribution arrangements in place.
Also, the UN system should offer appropriate technical expertise to advance progress.

(End)

Excerpt:

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:

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.

By Gustavo Capdevila
GENEVA, Apr 5 2013 (IPS)

India’s refusal to grant patent protection for the anti-cancer drug Glivec, developed by Swiss drugmaker Novartis, is a victory for the developing world, which depends on low-cost exports of generic medicines from the Asian giant, said public health specialist Germán Velásquez.

The triumph celebrated by the Colombian expert, who is a special adviser for health and development at the South Centre, was a landmark ruling against Novartis handed down Monday Apr. 1 by India’s Supreme Court.

The Geneva-based South Centre is an intergovernmental organisation of more than 50 developing countries that functions as an independent policy think tank.

Velásquez, who worked for over 20 years in the World Health Organization, explains in this interview with IPS his point of view on the legal battle in the courts in New Delhi and its consequences for developing countries.

Q: How do you interpret the ruling by the Supreme Court of India?

A: There are problems with the information that is being reported. Nearly everyone says that India rejected the patent for Glivec. That’s true, but it’s not all the verdict says.

Q: Could you explain?

A: At the heart of the verdict is the ratification of the criteria set by the Indian law for the approval of drug patents. That is, whether or not it meets the requisite of containing a genuine innovation.

Q: Could you describe the legal battle?

A: It all starts with the adoption of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), one of the treaties established at the same time the WHO was born, in 1995.

India was the only developing country to use the (entire 10-year) transition period to enforce TRIPS, in 2005, when it passed the patent act.

Q: What happened to the patent applications presented during that decade-long transition?

A: They accumulated, until there were around 10,000 applications, and it was not until 2005 that the patent office began to examine them. They included the application for the Glivec patent.

But the new standards turned out to be stricter, such as the one that indicates that the innovation can’t be just a small change to a molecule, but has to be something substantial. In short, the patent for local sales of Glivec was denied in 2006.

Q: How does the story continue from there?

A: Novartis challenged that decision and brought a lawsuit in a court in the city of Madras (the capital of the southern state of Tamil Nadu; the city was renamed Chennai in 1996.) But the High Court of that city, three years later, also rejected the application. That year, 2009, the company appealed the decision – and lost again.

Q: What options are left to the company?

A: This is the aspect that hasn’t been sufficiently reported. In a cynical, perverse and very serious move, Novartis says (prior to the ruling): “If they didn’t give me the patent, I’ll go to the Supreme Court, but to ask this time for the elimination of the strict criterion established in article 3 of the patent act.”

“If more flexible, lower standards are set, then my medicine will be in,” was its reasoning.

Q: So the dispute took on this other face?

A: Yes, because with the intention of introducing its drug by force, the transnational corporation was trying to modify the law of a country – and of a country like India. I think that its executives were being short-sighted when they made that decision. This has been very costly for them in terms of their image.

Q: How do you reach that conclusion?

A: It is clear that it was a misstep to denounce India’s patent law, with the risk of losing. The transnational industry in general had suffered a blunder in South Africa, when it was forced in 2001 to back down from legal action against a law that authorised the patenting of lower-price imported medicines in order to address the AIDS epidemic.

You could suppose that “Big Pharma”, as the major pharmaceutical companies are called, had learned the lesson. Especially knowing that Glivec was patented in 40 countries, including the United States, China and Russia.

Q: Are you insinuating that there may be a domino effect?

A: If Novartis loses in India, as it did on Monday, any of the governments of the 40 countries could ask themselves: “Why don’t I review that patent and revoke it?” That authority is granted by the legislation of all of those countries.

Q: What standing do those 40 countries that recognise the Glivec patent have?

A: Most of them are industrialised states, large markets. But they also include some that are currently experiencing severe economic difficulties, like Greece or Spain, whose authorities could ask themselves why they should pay 2,500 dollars a month per person for a treatment against cancer. They could say: “Why don’t I just have it produced as a generic drug, and invalidate this patent.”

I think the Novartis executives did not take that into account when they launched this legal battle. Obviously, after the first impetus, they continued on to the end, and today they’re going to see repercussions.

Q: What could those consequences be?

A: It should be a lesson for the rest of the countries of the developing South. They should try to follow India’s example and introduce in their legislation clauses like the ones contained in article 3d, which restricts and sets criteria with respect to what amounts to innovation, which is necessary in order to grant a patent. That there can’t just be a small change, which is sometimes merely cosmetic, to a molecule in the medication.

Q: What prospect is there for the spread of that criterion?

A: In India, the Philippines and Argentina, that prohibition already exists, while others are introducing it through alternative routes.

Q: And other consequences?

A: India will be able to continue to make generic versions of all new medicines that are not truly original, and it will continue exporting them without any problem. It’s necessary to take into account the fact that 95 percent of the antiretrovirals consumed in Africa come from that Asian country.

So that means the Indian Court’s ruling is extremely important, with very concrete repercussions for that medicine and some 10,000 others that are on the waiting list in the patent office in New Delhi.

Q: What percentage of those could get patents?

A: In 2010, Argentina approved 2,000 pharmaceutical patents, and China 4,000. But actually, just 40 or 50 products a year are true innovations.

Q: Why that enormous difference between patents that are granted and truly innovative products?

A: The pharmaceutical industry is facing huge difficulties in coming up with innovations.

So it clings to a very short-sighted way of thinking, very short-term, but enormously profitable. This consists of launching incremental innovations, as they are called – in other words, a small product with just a gradual change, but accompanied by a major marketing campaign.

Excerpt:

India may be famous for the Taj Mahal, its religious ceremonies, Bollywood films and one of the highest economic growth rates in recent years. But more importantly, India has had a positive global impact through its supply of vast quantities of low-cost, good-quality generic medicines, which have saved or prolonged millions of lives.

Many people go to India to buy life-saving generic medicines from pharmacies and bring these back in suitcases to give to close relatives who cannot afford the expensive branded original products.

A decade ago, the Indian pharmaceutical company Cipla produced generic HIV/AIDS drugs that could treat a patient for 300 dollars a year, far cheaper than the branded product’s cost of 10,000 dollars per patient a year. Today the Indian generic version is even cheaper, below 80 dollars.

Martin Khor. Credit: Nic Paget-Clarke.

This has enabled millions more AIDS patients to be treated, since India supplies 70 percent of the HIV/AIDS drugs obtained by the United Nations Children’s Fund (UNICEF), the Global Fund and the William J. Clinton Foundation for developing countries.

A further 75-80 percent of medicines (not only for AIDS) distributed by the International Dispensary Association to developing countries come from India. No wonder India has been termed the ‘pharmacy of the developing world’.

In January 2012, the Indian Drug Manufacturers’ Association (IDMA), comprised of 700 drug-manufacturing member companies, celebrated its 50th anniversary, by toasting the industry’s high growth, wide range of medicines, and its contribution to safe, affordable drugs.

But there are also many factors that may hinder the continuation of the country’s role as chief supplier of medicines to developing countries.

A main factor of the industry’s success was the government’s decision, back in 1970, to exclude pharmaceutical drugs from product patents.

This paved the way for local companies to produce generic versions of expensive foreign drugs and within a few decades they had taken over 80 percent of the domestic market, while also supplying cheap medicines abroad.

The situation took a negative turn when the intellectual property agreement, known as TRIPS, was established in 1995 together with the World Trade Organisation, which disallowed countries from excluding medicines from patentability.

However, TRIPS allowed individual countries to determine the criteria for an invention that can be granted a patent. Furthermore, TRIPS gave governments the ability to grant a compulsory licence to local companies to produce the patented products, if their requests to patent owners for a voluntary licence did not succeed.

To implement its TRIPS obligations, India passed changes to its patent law in 2005 so that drugs could now be patented. However, the new law also contained flexibilities such as strict criteria for patentability (trivial changes to a patent-expired product would not qualify for a new patent); allowance for public opposition to a patent application before a decision is made; and compulsory licencing.

India has one of the best patent laws in the world that still gives some space to its producers to make generic drugs. But it is also true that the old policy space has been eroded because many new drugs have, since 2005, been patented by multinational companies that are selling them at exorbitant prices.

Indian companies can no longer make their own generic versions of these new medicines unless they successfully apply to the government for compulsory licences, a most cumbersome process; or unless they obtain a licence from the patent-owning multinational, which comes with stringent conditions, especially for export.

Another worry is that India is negotiating a free trade agreement (FTA) with the European Union. Such agreements usually contain provisions such as data exclusivity and extension of the patent term, which prevents or hinders generic production.

Finally, six Indian companies were recently bought up by large foreign firms. If this trend continues, the Indian drug market may be dominated by multinationals again. It is uncertain whether they will continue to supply the developing world with cheap generic medicines when this may be in conflict with their own branded products.

International health organisations such as UNAIDS, UNITAID and Doctors Without Borders have raised their serious concerns that these recent trends may threaten India’s role as the chief supplier of affordable medicines to Africa and other developing countries.

Millions will die if India cannot produce the new HIV/AIDS medicines in the future –it is a matter of life and death, said Michel Sidibe, executive director of UNAIDS, during a visit to India last year.

Thus, a strategy is needed that involves the government and the drug companies, which ensures that the local drug industry continues to thrive; that it produces not only existing medicines but also new medicines even if they are patented; and that they are supplied at cheap prices not only in India but to the developing world.

That was the sobering message that emerged during IDMA’s 50th anniversary conference in January, even in the midst of congratulations on the achievements of the past. (END/COPYRIGHT IPS)

* Martin Khor is the executive director of the South Centre in Geneva.

This column is available for visitors to the IPS website only for reading. Reproduction in print or electronic media is prohibited. Media interested in republishing may contact romacol@ips.org

Protesters at the "We Can End AIDS Rally" Hold Up Pill Bottles. Credit: Amanda Wilson/IPS

By Amanda Wilson
WASHINGTON, Jul 26 2012 (IPS)

As the nineteenth International AIDS Conference continued in Washington Tuesday, thousands of protesters marched on the White House with a set of demands to end the epidemic.

At the forefront were calls for an end to free trade deals that protesters argue make vital AIDS medicines unaffordable.

The march comprised a coalition of AIDS advocacy and activist groups organised under the mantra “We Can End AIDS”, and ended with a dramatic display when activists gathered symbols of the fight against AIDS – pill bottles and money – tied them with red ribbons, and threw them in front of the White House.

A growing movement within the international advocacy community and those living with HIV/AIDS argue that free trade deals such as the Trans Pacific Partnership (TPP) – a deal the Barack Obama administration has been negotiating with 10 Pacific nations over the past three years –contain excessively stringent protections for pharmaceutical patents on AIDS drugs.

Lorena Di Giano of the Argentinian Network of Women living with HIV spoke at the rally, saying such free trade agreements “would make access to affordable drugs even more difficult”.

Medicine works, but who owns it?

Anti-retroviral (ARV) medicines are known to reduce the transmission of HIV, yet only one out of every two HIV-positive people are on ARVs worldwide. The number is lower for children, and still lower for people in the developing world. But, protesters say, patent protections do not help get more drugs to more patients, a step they say could dramatically halt the epidemic.

They say patents on drugs imported to developing or middle-income countries could block generic manufacturing, resulting in monopolies and higher prices for vital medications.

This trend, advocates say, will exclude and marginalise HIV-positive patients who do not fit within a narrow market of elite or middle-class consumers in middle-income countries who are increasingly targeted for drug sales.

That could mean bad news for patients in fast-growing, middle-income countries such as India and Brazil, where pharmaceutical companies have launched lawsuits against governments in order to enforce patents and block other manufacturers from producing their drugs.

Protesters say the situation is clear: pharmaceutical companies are suing governments for rights to exercise exclusive IP rights on effective new AIDS drugs, making clinical trials data secret, even as they target expensive new drugs to elites and a growing middle class while leaving the marginalised to fend for themselves, or even die.

Currently, certain free trade deals have some flexibility for countries that prefer not to enforce patents on pharmaceuticals. Under the World Bank’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), those exceptions expire in 2016. Protesters are arguing for their extension.

Brook Baker, a policy analyst and advocate on IP and access to medications with the U.S.-based AIDS advocacy organisation Health GAP, spoke at a panel session of the International AIDS Conference on Tuesday. He said a dramatic fall in prices for some drugs had lulled people into a false sense of security.

“We face a future in which IP protection in the form of data monopolies and patent monopolies stand in our way,” Baker said. “All new drugs are being created under much stricter IP regimes, and they can be two to three or even 10 times more expensive (than generics).”

Baker urged governments to accept recommendations related to IP in a July report issued by the Global Commission on HIV and The Law, an independent high-level legal commission made up of former heads of state and leading legal, human rights and HIV experts.

In its annual report, the commission this year recommended a moratorium on TRIPS patent enforcement on pharmaceutical products. “The HIV epidemic has exposed the serious problems of applying TRIPS to medicines and other pharmaceutical products,” the report notes. “This has implications well beyond HIV, for example, for non-communicable diseases which affect millions in high-, middle- and low-income countries.”

Baker said the need to address the link between patent law, pricing, and access was especially urgent in middle-income countries such as China, India, Brazil, and South Africa, which have 25 percent, or eight million, of all HIV-positive people.

“They (pharmaceutical companies) are interested in selling to the elites and a growing middle class,” Baker said. “If you get a right to exclude competition and you price your medications for the elite,” people are going to be marginalised, he said.

Tahir Amin, an international IP scholar, emphasised that, through a process called “evergreening”, many new patents on drugs are simply patents on slight changes in compounds being passed off as brand new drugs. “It shocks me to think that this is innovation,” he said.

Sarah Zaidi of the International Treatment Preparedness Coalition (ITPC), based in Thailand, pointed out that the number of free trade agreements had increased from eight in 2001 to 72 in 2012. She said strong IP clauses show the strength of the pharmaceutical patent holders.

“It’s really criminal when you know the evidence around treatment and prevention and the one thing that is keeping you from accessing these drugs are patents,” Zaidi told IPS. “It’s a tragedy.”