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

By Brendon Bosworth
CAPE TOWN, South Africa, Dec 12 2013 (IPS)

Paul Anley, chief executive officer of Pharma Dynamics, one of South Africa’s leading generic drug companies, wants to sell a cheaper version of popular birth control pill Yasmin. But he legally cannot because German multinational Bayer has patent protection on the drug in South Africa, even though its initial patent expired in 2010.

Generic versions of the contraceptive are available in the United States and Europe, where Bayer’s patent has been revoked.

Anley says South Africa’s patent system makes it easy for multinational pharmaceutical companies to make minor changes to their products and get multiple patents, each spanning 20 years, and keep generics off the market.

“Multinational pharmaceutical companies undertake a process of what we call patent ‘evergreening,’” Anley told IPS. “They will literally flood the patent office with hundreds of patents for every single molecule or product they sell, and they do it over a protracted period.”

Pharma Dynamics lost a court case against Bayer over the validity of Bayer’s patent, which relates to the rate at which the drug’s active ingredient dissolves, in March 2013. It is barred from selling its generic and has filed an appeal against the decision.

“Bayer will continue to vigorously defend its patents,” Bayer’s medical director, Dr. Gené van den Ende, told IPS in an emailed response. Van den Ende did not comment on allegations of evergreening.

Since 2002, Bayer has filed for 11 different patents in South Africa for one of the active ingredients in Yasmin.

Plenty of patents?

In September, South Africa’s Department of Trade and Industry released a draft national policy on intellectual property that proposes changing South Africa’s patent system.

Anley and patent reform advocates like HIV advocacy group the Treatment Action Campaign and Médecins Sans Frontières hope the proposals will curb the number of patents granted and increase access to cheaper medicines.

“We grant far more patents than other countries, both developing and developed,” Catherine Tomlinson, a researcher with Treatment Action Campaign, told IPS. “A lot of what we’re providing patents on is not actually meeting patent standards to provide something new and innovative.”

In 2008, South Africa granted 2,442 pharmaceutical patents, according to research by Carlos Correa at the University of Buenos Aires’ South Centre. Brazil granted just 278 patents between 2003 and 2008.

Supporters of patent reform point to the price difference between originator drugs in South Africa and generics available in countries like India – which has been strict in denying patents for formulations of new medicines – as a consequence of South Africa’s patent laws.

The Treatment Action Campaign found that generic versions of popular cancer drugs are available in India for between four percent and 44 percent of the cost of originator versions in South Africa, based on a comparison of 2012 prices.

India has made also use of compulsory licencing. In cases where government feels the price of a drug is too high, it can grant licenses that allow generics manufacturers to produce versions of drugs under patent protection without consent of the patent owner. The World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights Agreement allows for compulsory licencing.

As a signatory to the WTO agreement, South Africa can grant compulsory licences but has not done so in the past.

The draft national policy recommends introducing the use of compulsory licenses. But whether or not these are granted in the future depends on the interpretation of the courts, patent attorney Madelein Kleyn, who is the intellectual property manager for Oro Agri and a research fellow at Stellenbosch University’s Anton Mostert Chair of Intellectual Property Law, told IPS.

Long road to reform

Government’s draft intellectual property policy recommends introducing a search and examination process to the South African patent office that involves having experts assess the novelty or original merit of an invention.

Currently, those applying for patents in South Africa need to fill out the application documents correctly and pay the required fees. If a company or individual wishes to challenge the validity of a patent after it’s granted, the challenge must be done through the courts.

Intellectual property lawyers note that government does not have the staff required to perform search and examination procedures.

“The patent office, as it stands, currently lacks skilled force to implement such a system,” said Kleyn. “Patent examiners are highly qualified people who specialize in the different areas of technology and require an in-depth understanding of the patentability requirements to assess a new filed invention against the prior art of the specific technical area.”

Outsourcing this work to international or regional offices, as suggested in the draft policy, would make sense, she said.

Since patents can be revoked through the courts, and intellectual property professionals advise patent applicants to amend their claims based on foreign patent cases, the system in South Africa allows for strong and tested patents despite the lack of a search and examination process, Kleyn explained.

She recommended focusing on educating judges who deal with patent cases to make the legal system work more effectively instead. This shift would also be cheaper.

If introduced, the search and examination procedure would take a long time to alter the patent landscape.

“The system will not eliminate the weak patents that will be on the register by the time the system is introduced in say (being kind) five years,” wrote former deputy president of South Africa’s Supreme Court of Appeal Louis Harms in his comments on the draft policy. “This means that weak patents will still be around for 25 years.”

Anley, of Pharma Dynamics, agreed that the proposed changes would take time to take effect.

“We’re very encouraged that government recognises the problems facing generic pharmaceutical companies and has addressed most of them in the draft,” he said. “Our concern would be that the process of capacity building is a very long and difficult process.”

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.

Intellectual property provisions proposed by the United States would extend monopoly powers derived from patents to pharmaceutical companies that sell their medicines abroad. Credit: Bigstock

By Jared Metzker
WASHINGTON, Jul 16 2013 (IPS)

As a new round of talks behind a major proposed free trade area, the Trans-Pacific Partnership (TPP), get underway this week, the United States is pushing several developing countries to accept provisions that critics say would make it more difficult for their citizens to access medicine.

“The concern about access to medicine, and that the TPP deal will lead to high health-care costs, is huge,” Arthur Stamoulis, executive director of Citizens Trade Campaign, a fair trade advocacy group based here, told IPS.“TPP is certainly not being written in the interest of small business owners or working people.” -- Arthur Stamoulis of the Citizens Trade Campaign

On Monday, as negotiations for the TPP enter their 18th round, Medecins Sans Frontieres (MSF), a humanitarian organisation, reflected this concern, urged negotiating countries “to remove terms that could block people from accessing affordable medicines, choke off production of generic medicines, and constrain the ability of governments to pass laws in the interest of public health.”

Negotiations for the TPP, which officially started in 2010, are currently being held in Malaysia, and the countries participating include the United States, Australia, New Zealand, Chile, Peru, Brunei, Singapore, Malaysia, Vietnam, Canada and Mexico.

Japan is expected to join at the end of this round, while others have expressed interest in signing on, as well.

The Office of the United States Trade Representative has explained that the purpose of the deal is to “enhance trade and investment among the TPP partner countries, promote innovation, economic growth and development, and support the creation and retention of jobs.”

Yet critics have long warned that the United States appeared to be setting onerous conditions for any agreement, while complaining that the talks have been held in near secrecy, lacking oversight even from the U.S. Congress.

While intellectual property provisions proposed by the United States may be intended to promote innovation, MSF notes that they would extend monopoly powers derived from patents to pharmaceutical companies that sell their medicines abroad.

This means that it would take longer for cheaper generic drugs to come to market in low-income countries, where citizens often struggle to afford basic necessities.

Further, by hamstringing Asian suppliers of generic drugs, the effect of TTP’s restrictive intellectual property provisions could ultimately reverberate beyond the countries involved in the agreement.

“The critically important role that many Asian countries have in supplying both generic medicines and the active pharmaceutical ingredients needed to produce drugs is in jeopardy because of new restrictions proposed in the TPP,” says Judit Rius Sanjuan, U.S. manager of MSF’s Access Campaign.

“The TPP threatens to put a stranglehold on the world’s supply of affordable treatments, with dire consequences for patients, treatment providers, and pharmaceutical producers in developing countries.”

The proposed agreement could facilitate “evergreening” by patent-holding pharmaceutical companies, a term that refers to legal manoeuvres that, when successful, lead to monopoly powers being maintained longer than the 20 years typically allotted by patents.

Imposing these types of new restrictions would run counter to previous international agreements and national legislation under which Washington has pledged to expand access to generic medicines.

Any restriction in access to such medicines would also affect the United States’ own global health goals. Generics are said to make up some 98 percent of the medicines used by PEPFAR, the United States’ flagship anti-HIV/AIDS programme and the world’s largest.

MSF calls the practice of evergreening “abusive”. Further, under a free trade agreement all adhering countries would conform their laws, and the standard promoted by the United States would, the group is warning, do so in a way that would make evergreening more feasible abroad.

Sense of urgency

For the administration of President Barack Obama, there has been a sense of urgency to finish the TPP negotiations by the fall. Some observers have suggested that this could lead countries that would otherwise reject the clauses affecting access to medicine to allow them to remain.

“We are hearing from other negotiating teams that the pressure to finalise this agreement by October is rising,” Sanjuan told IPS during a previous round of negotiations, “and they fear that if there is not more time for substantive discussion, this chapter could stand.”

She also notes that negotiations are being carried out in secret and without input from civil society. Her office became aware of the clauses related to intellectual property and access to medicine only after text of a chapter was leaked to them.

In fact, concerned groups and the media have had extremely limited opportunities to speak with negotiators. Much of the communication has occurred at so-called “stakeholder meetings”, wherein groups are allowed to make brief presentations to certain negotiators and given controlled access to speak face-to-face with them.

IPS recently attended a stakeholder meeting related to another major proposed U.S.-led free trade agreement and was told by multiple delegates that the information they could divulge was very limited.

That lack of transparency is being interpreted by some as a clear indication that the TPP agreement is not being negotiated in the interest of the general public. Indeed, the vast majority of those who have had access to the TPP talks have been representatives of major corporations.

“TPP is certainly not being written in the interest of small business owners or working people,” the Citizens Trade Campaign’s Stamoulis says. Instead, he suggests it will serve the interest of “a small handful of very powerful corporations”.

Stamoulis, too, notes mounting pressure on negotiators to finish the deal by the end of the year.

“They’re definitely going full steam ahead to get this thing done as fast as possible, there’s no doubt about that,” he says.

For her part, Sanjuan recommends that the urgency of those looking to push the agreement through be met by urgency on the part of those who want to avoid restricting medicinal access to poor people.

“The time for negotiators to fix the TPP is now, in this round of talks, before political pressure escalates and a deal that is bad for public health is sealed in the interest of time.”

"Pay to delay" agreements may cost consumers in the United States up to 3.5 billion dollars per year. Credit: Bigstock

By Carey L. Biron
WASHINGTON, Jun 17 2013 (IPS)

The Supreme Court pushed back Monday against a longstanding practise in the U.S. pharmaceuticals industry under which large-scale companies pay producers of generic copies to hold off introducing those low-cost drugs into the marketplace.

The practise, known as “reverse payments”, maintains a company’s lucrative monopoly over a drug, often resulting in significant extra income. Yet critics, including the U.S. government, have for years warned that the practise was both anti-competitive and harmful for consumers, who are forced to pay more for drugs.

While the decision did not declare reverse payments to be outright illegal, as the government had hoped, it does now allow the Federal Trade Commission (FTC) to move forward with court cases against these arrangements, known colloquially as “pay to delay”. The decision also reversed previous rulings by lower courts.

“[T]he specific restraint at issue has the ‘potential for genuine adverse effects on competition,'” Justice Stephen Breyer wrote for the majority in the 5-3 ruling. “Payment for staying out of the market keeps prices at patentee-set levels and divides the benefit between the patentee and the challenger, while the consumer loses.”

According to advocates of the changes, competition from generics can often lower drugs prices by up to 90 percent. The FTC, meanwhile, has estimated that agreements to push off such competition cost consumers some 3.5 billion dollars per year in the United States alone. "Reverse payments are a win-win for both the brand-name and generic companies."
-- Laura Etherton

Beyond setting an important legal precedent, the ruling will likely have little immediate impact outside of the United States, as the patents in question likely do not extend overseas.

Brand-name drugs comprised just 18 percent of all U.S. prescriptions written in 2011, according to statistics from IMS Health, a research company. Yet they accounted for almost three quarters of revenue for the industry, worth some 320 billion dollars a year.

“The incentives to engage in research and development are already out there without these kinds of agreements,” Scott Nelson, an attorney with Public Citizen, a public interest watchdog, told IPS.

“Signing one of these agreements will mean you may have to fight the U.S. government. Hopefully, the impact will be that companies think twice before entering into these types of agreements, which are basically just arrangements to split up profits under which consumers lose out.”

Collusive agreements

The Supreme Court decision revolves around 1984 federal legislation, known as the Hatch-Waxman Act, that was meant specifically to push generic drugs onto the market more quickly. As Nelson noted, this law offers incentives for the development of new drugs such as decades-long patents.

But it also allowed generics manufacturers to challenge these patents for a variety of reasons. According to a study by the FTC, until the early 2000s, the generics companies prevailed in these challenges almost three quarters of the time.

Yet reverse payments arrangements offered a lucrative loophole in this process.

“Today, the court echoed what I, along with many other members of Congress, have repeatedly said:  the over-arching goal of Waxman-Hatch is to foster competition in the pharmaceutical industry,” Henry Waxman, a member of the House of Representatives and co-author on the 1984 bill, said Thursday.

“The type of collusive agreement at issue in this case represents a total perversion of the spirit of this law. This is a significant victory for consumers.”

Increasingly over the past decade, brand-name drugs manufacturers have moved to counter-sue generics companies following the filing of a challenge. Typically the companies would allege patent infringement and threaten a lengthy and costly court fight.

Thereafter, the two companies would arrive at a large cash settlement – the reverse payment – along with an agreement that the generics manufacturer would not introduce any related product into the marketplace for a set period of time.

The case before the court involved a type of synthetic testosterone, called AndroGel, used by cancer sufferers and others. The brand-name version of this drug cost around 379 dollars for a month’s supply.

While the introduction of a generic version could have knocked that price down to around 40 dollars, a deal between AndroGel’s manufacturer and a number of generics companies pushed off the introduction of a low-cost AndroGel until August 2015.

“These reverse payments are a win-win for both the brand-name and generic companies, as the latter essentially gets a share of the profits but the brand name gets to hold onto its monopoly for longer than,” Laura Etherton, a health policy analyst with U.S. PIRG, a consumer rights advocacy group, told IPS.

“The problem is these deals are lose-lose for consumers and taxpayers, as consumers end up paying billions more for these drugs, while taxpayers are forced to foot higher bills for [social safety-net programmes]. That’s the wrong way to go about making necessary medications available for the public.”

According to information provided by U.S. PIRG, such deals have delayed the introduction of generic drugs meant to fight AIDS, cancer and high blood pressure, among other diseases.

Legislative next step

Still, for advocates like Etherton, Monday’s decision did not go far enough.

“We are disappointed the court didn’t take the next step and outright outlaw this anti-competitive practice,” she said.

“But the silver lining in not taking that next step is that the case has really raised the profile of this issue. Our hope now is that Congress will give the issue the attention it deserves and end ‘pay for delay’ once and for all.”

Two pieces of legislation are currently pending in the U.S. Senate that would crack down further on reverse payments. One would seek to reduce the incentive for generic companies to enter into “pay for delay” agreements, by allowing a second generic company to circumvent such an arrangement and bring the drug to market.

A second proposal would outlaw such payments entirely. Federal auditors estimate that such a move would save the government some 11 billion dollars over a decade, in addition to consumer costs.

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’s highest court has dismissed Swiss drug maker Novartis AG’s petition seeking patent protection for a cancer drug, a serious blow to Western pharmaceutical firms which are increasingly focusing on India to drive sales.

In a landmark judgement, the Supreme Court said on Monday that the drug Glivec failed to qualify for a patent according to Indian law.

Since 2006, Novartis has been challenging the Indian government to give protection against Indian companies copying its drugs.

But the court ruled that the drug for which Novartis was seeking a patent “did not satisfy the test of novelty or inventiveness” required by Indian law.

In 2009 the company took its challenge against a law that bans patents on newer but not radically different forms of known drugs to the Supreme Court.

Al Jazeera’s Sohail Rahman, reporting from New Delhi, said the ruling is a “huge disappointment” for Novartis, as it allows Indian companies to continue producing cheaper generic medicine for domestic and international consumers.

Rahman said the ruling could raise questions about India breaking rules set by the World Trade Organization.

The case is the most high-profile of several patent battles being waged in India and could have far-reaching implications in defining the extent of patent protection for multinational drug firms operating in the lucrative market.

‘Dangerous precedent’

The Swiss firm threatened to halt supplies of new medicines to India if the court did not rule in its favour, London’s Financial Times reported on Sunday.

“If the situation stays as now, all improvements on an original compound are not protectable and such drugs would probably not be rolled out in India,” said executive Paul Herrling, who is leading the company’s handling of the case.

But Leena Menghaney, a lawyer with medical charity Medecins Sans Frontieres (MSF), said a legal victory for Novartis could “set a dangerous precedent, severely weakening India’s legal norms against evergreening” – the name given to the industry practice of seeking new patents after making small modifications to existing drugs.

It would “be dire for people in the developing world who depend on generic drugs made in this country. It could seriously curb access.”

Generic drug firms in India – long known as the “pharmacy to the developing world” – have been a major supplier of copycat medicines to treat diseases such as cancer, TB and AIDS for those who cannot afford expensive branded versions.

The cost difference between generic and branded drugs is crucial for poor people around the world, MSF says.

It points out that Glivec – often hailed as a “silver bullet” for its breakthrough in treating a deadly form of leukaemia – costs 4,000 dollars a month in its branded form while its generic version is available in India for around 73 dollars.

In the case of Glivec, Al Jazeera’s Rahman also said that most of the consumers in India could not even afford the drug given the average wage is only 120 dollars.

But Novartis and other global drug makers say India’s generics industry inhibits pharmaceutical innovation and reduces commercial incentives to produce cutting-edge medicines.

* Published under an agreement with Al Jazeera.

Days before leaders of the European Union (EU) arrived in Norway to collect this year’s Nobel Peace prize, Thai public health activists sent a letter to the northern powerhouse, warning that the EU’s 2012 accolades face a credibility test in this Southeast Asian country.

They had in mind the fate of Thailand’s generic drugs supply-line when Bangkok and the EU begin talks in early 2013 for a free trade agreement (FTA). The letter to Joao Aguiar Machado, deputy director general for trade at the European Commission, called for the bloc to respect global trade rules’ special provisions for developing countries.

The EU’s history of pressuring various developing countries around the world to comply with its conditions and requirements in free trade negotiations – which seek to remove all barriers to EU firms wishing to do business abroad – run “contrary to the expectations” of a Nobel Peace laureate, added the letter sent days before the Dec. 10 awards ceremony in Oslo.

“We are worried that the EU negotiators will force Thailand to accept new conditions on patents that would make access to new generic drugs more difficult,” says Chalermsak Kittitrakul, campaign officer at the AIDS Access Foundation. “People with HIV and patients needing medicines for cancer, heart disease and diabetes will have to pay more.”

“These clauses in a Thai-EU FTA would make it difficult for Thailand to produce or import generic drugs,” he told IPS. “It will pave the way for big pharmaceutical companies to monopolise the market and undermine generic competition.”

The EU is Thailand’s second largest trading partner after the ten-member Association of Southeast Asian Nations (ASEAN). According to Thai officials, bilateral trade between the two partners stood at 35 billion dollars in 2010.

Thai activists want the negotiating text for the bilateral trade deal to stay within the bounds of the World Trade Organisation (WTO) law on Trade-Related aspects of Intellectual Property Rights (TRIPS), which was adopted during the groundbreaking international trade talks in Doha in 2001.

This provision permits developing countries with health emergencies to break the drug patents of pharmaceutical giants to either produce or import generic drugs.

But the FTA negotiations the EU has pursued with Thailand’s southern neighbours, Malaysia and Singapore, have raised concerns about what could lie in wait when the EU begins its bilateral trade talks with Bangkok next year.

“They (the Brussels negotiators) are pushing for TRIP-Plus demands such as data exclusivity,” says Paul Cawthorne, an officer with the Access to Essential Medicines Campaign launched by the global humanitarian agency Doctors Without Borders (known by its French acronym MSF).

According to a leaked document from a Thai trade negotiating team seen by activists here, there is a chance that the EU-Thai FTA could include five years of data exclusivity for new drugs, a clause designed to stop safety-related clinical test or trial data submitted to regulatory authorities from being used by the manufacturers of generic drugs.

“This will slow down the process to produce and supply new drugs to the generic market,” Cawthorne told IPS. “This blocking tactic using data exclusivity will have a broader impact because Thailand has been a producer of generic drugs for years.”

Data exclusivity is not currently required by international law, argues Cawthorne. “The TRIPS agreements require (WTO) member-states to protect clinical data, but there is no obligation to grant any period of monopoly or exclusivity in the use of these data.”

Thai health activists are hoping that their record of mounting successful campaigns against pharmaceutical giants – even from the United States – to ensure a thriving generic drugs market for patients in the country and across the region remains intact.

The last showdown was in mid-2007, when activists threw their weight behind the then Thai government to invoke a WTO rule to secure generic drugs.

In January that year, Bangkok issued a ‘compulsory licence’ (CL) to buy cheaper alternative antiretroviral drugs (ARVs) from India, bringing the country a reputation as another battleground for pharmaceutical giants determined to protect their intellectual property rights and profits from the generic drugs lobby.

Thailand, once one of the region’s countries worst hit by AIDS, is currently home to about 600,000 people with HIV, of which 200,000 people have access to first- and second-line ARVs from government hospitals.

Such ARV coverage has earned the country praise in the region, adding to a long list of achievements to contain the spread of the killer disease and care for those infected.

Issuing CLs has meant Thais with lung and breast cancer and heart disease have had access to cheaper generic drugs since 2007, the year that even saw the Thai push for generics being endorsed by the World Bank.

The Washington-based financial institution revealed in a report that the use of CLs in Thailand’s AIDS treatment programme would slash the cost of second-line drug treatments by 90 percent, helping the country to save an estimated 3.2 billion dollars over 20 years.

Such details are expected to fortify the current campaign. “It makes economic and public health sense for Thailand to strengthen its generic drugs supply and not expose it to TRIPS-plus measures,” says Jacques-chai Chomthongdi, research associate at Focus on the Global South, a Bangkok-based think tank.

“Activists want the process to include public participation to protect the interests of people who need generic drugs,” he told IPS. “They have received word that the EU is insisting that TRIPS-plus provisions be included as a prerequisite to the FTA talks.”

A new kind of public-private partnership will begin in 2013 in Brazil to produce an antiretroviral drug, through a technology transfer agreement that will be in effect until the patent expires in 2017.

The productive development partnership is based on an agreement with New York-based drug maker Bristol-Myers Squibb, to produce atazanavir sulphate.

The drug will be made by Farmanguinhos, a technical-scientific unit of the Oswaldo Cruz Foundation (Fiocruz) and the Health Ministry’s largest pharmaceutical laboratory.

It will be distributed in the public health network as part of the antiretroviral (ARV) cocktail therapy that is provided free of charge to everyone who needs it in this country of 194 million people.

“It’s an important symbolic process,” Dirceu Greco, the director of the Health Ministry’s Department of Sexually Transmitted Diseases, AIDS and Hepatitis (DDST), told IPS, referring to the five-year agreement with Bristol-Myers Squibb, which will represent some 200 million dollars in savings for Brazil.

“The Health Ministry programme is part of a national plan to reduce the deficit in the country’s trade balance in the area of medicines,” Gaetano Crupi, president of Bristol-Myers Squibb Brazil, said in an interview with IPS. “Today atazanavir is 100 percent imported.”

“The government of Dilma Rousseff wants, first, to cut the trade deficit, and second, to save money in the long term by producing the drug at a national level,” he said.

This is the first time Brazil is entering into a partnership with a private company to produce a drug that is still protected by a patent, and that is very important in the national response to AIDS treatment, he added.

“The important thing about this partnership is that it will give us a greater degree of sovereignty in the production of a medication, because the technology will be incorporated by our country, and there will be savings as well, since the medicine will be offered to the government at a reduced price,” Health Minister Alexandre Padilla said.

Since 1996, Brazil has provided universal free ARV treatment, which now benefits some 217,000 people. The Sistema Único de Saúde (SUS – Single Health System), the public health network, treats 97 percent of people diagnosed with HIV/AIDS in the country.

Pedro Chequer, United Nations Joint Programme on HIV/AIDS representative in Brazil, said it was a stride forward “that this country maintains its policy of (universal) access with its own funds and largely with its own production of medicine.”

The Health Ministry distributes 20 ARV drugs at a cost of around 425 million dollars a year. Eight of them are produced by Productive Development Partnerships.

“In the midst of an economic crisis, continuing this strategy was a political decision in favour of the public,” Greco said.

The agreement for the production of atazanavir sulphate provides for the transfer of technology to a national laboratory, as well as the manufacturing and distribution of the drug for five years.

Farmanguinhos has acquired equipment for the production and will receive training from Bristol-Myers Squibb.

Atazanavir sulphate, which is in the protease inhibitor class of ARVs, will start to be distributed in packaging with the Farmanguinhos logo in 2013. But it will only begin to be produced with national technology in early 2015.

A total of 99 million 300-mg tablets will be distributed between 2013 and 2017.

“This will be the 11th ARV medicine produced in Brazil,” Greco said. “The main advance was to ensure that we could manufacture and distribute essential anti-AIDS medicines with public funds.”

“In my view, the idea of having a small state structure has serious consequences in the area of health,” he added.

Brazil, through Farmanguinhos, has agreements to supply medication to other developing countries, in Latin America and Africa, through what it considers one of the main arms of its foreign policy: South-South cooperation.

Crupi added that “What to do when the patent expires is a strategic decision that the government will resolve.”

Having met 97 percent of domestic demand for generic drugs, Bangladesh is poised to become a major exporter. Credit: Naimul Haq/IPS

By Naimul Haq
DHAKA, Nov 18 2012 (IPS)

Bangladesh has begun to shed its image as one of the world’s poorest nations and make a reputation for itself as a major exporter of cheap generic drugs to over 85 countries.

Listed by the United Nations as one of the least developed countries (LDCs), Bangladesh has exported drugs worth roughly 50 million dollars since 2011.

While this is admittedly just a fraction of the 170-billion-dollar global generic drug market, recent trends indicate that this South Asian country, home to over 150 million people, is poised to capture a larger slice of the market if it plays its cards right.

Competition for production of quality generics began in 1982, when the Drug Control Ordinance encouraged expansion in domestic production.

Following the exit of major multinational producers, local companies rushed to establish internationally recognised good manufacturing practices (GMP) and local investors were encouraged to join the flourishing market.

Local manufacturing giants like Square, Incepta Pharmaceuticals, Beximco and a host of others emerged within a very short period of time.

Abdul Muktadir, secretary general of the Bangladesh Association of Pharmaceutical Industries (BAPI), and managing director of Incepta Pharmaceuticals, the second largest drug manufacturer in the country, told IPS, “The drug industry grew at a steady pace and now Bangladeshi drugs are exported to many Asian, African and South American nations. The reason for this global expansion is quality, which has also (enabled) us to enter the European market. Soon we may get approval to export into the United States.”

“Our (share) of exports is still far too small, but growth patterns suggest we will soon overtake other major export sectors” such as garments, jute and tea, according to BAPI Vice President  Momenul Haq.

Cheaper prices also make drugs produced here an attractive product, he told IPS.

Out of a total of about 200 active local drug manufacturers, the top twenty companies have been exporting the lion’s share of drugs – about 85 percent – since the middle of the 1990s.

The boom in exports did not, however, accelerate until 2005 when the country’s original 1982 drug policy was revised.

The new programme, recognising that the industry already answered 97 percent of local demand, gave top priority to exports, which resulted in a decade of sharp growth.

In 2001 only a handful of generic drugs, with sales amounting to 3.7 million dollars, were exported to just 17 neighbouring countries; today more than 300 generics are exported to 87 countries, with sales topping 50.4 million dollars in 2011.

According to the Exports Promotion Bureau, some of the major beneficiaries in 2011 were manufacturers like Novartis Bangladesh, which exported drugs worth 10.8 million dollars; Beximco, whose sales receipts amounted to 9.6 million dollars and Square, which sold 7.8 million dollars worth of medicines abroad.

Haq, who is also the owner of General Pharmaceuticals, said, “Slow registration processes in destination countries, especially in moderately regulated markets (such as South Korea, Italy, Germany, Belgium, Spain and Singapore) make exporting difficult. But amid all these strict regulations Bangladesh has emerged as a successful drug exporter and it is still expanding.”

Out of about 1,800 generics or molecules manufactured in the country some 300 varieties are now exported, mostly antibiotics, analgesics, contraceptives, stimulants, vitamins, dietary supplements and non-conventional herbal and Ayurvedic medicines. Destination countries for these drugs include Saudi Arabia, Yemen, Kenya, Malaysia, Bhutan, Azerbaijan, Honduras and Mexico, among many others.

Strict tax codes ensure that a significant portion of these profits circle back into the local economy, which could boost Bangladesh’s efforts to graduate from LDC to middle-income economy status.

Already foreign loan dependency has fallen from 85 percent in the early 1980s to about two percent in 2012.

Per capital income has increased from less than 400 dollars in 2001 to 650 dollars in 2010.

A thriving export market could boost growth even further, experts say.

The domestic drug consumption market was worth 958.8 million dollars in 2010 and is expected to rise by at least ten percent every year, due largely to the expansion of quality healthcare services and increasing purchasing capacity.

Patents loom as threat to production

But the road ahead is not without its share of obstacles.

Zafrullah Chowdhury, widely acknowledged as the leading expert on pharmaceutical policy in Bangladesh and a key player in formulating the 1982 Drug Ordinance, told IPS, “It is time we started making raw or active ingredients, because after World Trade Organisation (WTO) patent exemptions expire in 2016” Bangladesh may not be able to produce generic medicines as easily as it does now.

According to the WTO’s agreement on the trade-related aspects of intellectual property rights (TRIPS), Bangladesh, along with other LDCs, is excused from patent regulations until 2016. However, when they kick in four years from now, patent requirements could deal a fatal blow to the industry.

“In January 2016, Bangladesh’s pharmaceutical market will face difficulties, particularly with under-patent drugs (new drugs invented after 1996),” Sayedur Rahman, professor of pharmacology at the country’s renowned Sheikh Mujib Medical University (BSMMU) in Dhaka, told IPS.

“At this moment, we have about 150 drugs of this category, the prices of which might increase as a consequence of royalties (demanded by) patent holders.”

“Initially, those patent holders may not claim royalty, but after some time they will definitely enter our market to sell their products, employ distributors or claim royalty from the local manufacturers.

“Failure to negotiate with patent holders may lead to removal of the drug from the market as well as delayed entry of new drugs,” he added.

“(TRIPS regulations) will not affect ‘out of patent’ or older drugs (drugs innovated 20 years ago), which can be sold at the same price even after 2016. Ninety percent of our patients can be treated optimally with these old drugs, though this will require some rationalisation of the present prescribing trend,” Rahman added.

However, the expiration of patent exemptions in 2016 could also be a moment for Bangladesh enter a gap in the international market that was hitherto filled by cheap drugs produced in India.

According to BAPI’s Muktadhir, “The global generic market is finding new growth pathways as more and more products face patent expiry. (A vast majority of countries) are now dependent on the supply of Indian generic drugs and they are seriously looking for an alternative source with a similar industry standard.

“BAPI is trying to develop the (local) industry to meet this gap in the international market,” he said.

Nasser Shahrear Zahedee, owner of Radiant Pharmaceuticals, described Bangladesh’s current export scenario as a “warm-up phase”.

“Unless we can embrace competition (that produces) quality drugs,” he said, “we will not be able to enter highly regulated markets, which should be our ultimate target.”

(END)

HIV positive people in New Delhi demonstrate for access to cheap generic drugs. Credit: Mudit Mathur/IPS

By Zofeen Ebrahim
BEIJING, Nov 8 2012 (IPS)

As the northern Indian state of Rajasthan rolls out an ambitious universal healthcare plan, the discontent of the state’s doctors stands in stark contrast to the joys of the 68 million people who will benefit from the scheme.

Just a little over a year ago, the state government began supplying free generic drugs to its massive population, effectively stripping doctors of the ability to prescribe more expensive branded medicine.

Some 350 essential generic drugs are now being distributed free of cost. As a result, outpatient visits have jumped 60 percent and inpatient admissions are up 30 percent, despite the fact that public health facilities are overcrowded and understaffed, and many people have to travel long distances to reach one.

According to news reports, over 200,000 people are currently taking advantage of the programme.

“(This) has broken the cosy relationship enjoyed for decades between doctors and (drug) manufacturers,” Dr. Nirmal Kumar Gurbani, advisor to the Rajasthan Medical Service Corporation (RMSC) that was constituted by Chief Minister Ashok Gehlot to run the scheme, said during a presentation at the Second Global Symposium on Health Systems Research in Beijing last week.

Gurbani, a professor at the Indian Institute of Health Management and Research (IIHMR), added that the ‘Rajasthan model’ is being used as pilot for a similar scheme throughout India, which could bring free drugs to the country’s 1.2 billion residents.

One of the programme’s goals is to end price manipulations of private pharmacies and manufacturers.

“Cipla, for example, produces three kinds of ‘cold’ tablets, which all have the same chemical ingredients. It sells the generic drugs to pharmacies at a wholesale price of about two Indian rupees (0.03 dollars) per pack (of ten tablets) but sells the branded drugs for 23 rupees (0.42 dollars) per pack.

“The chemist then sells all three drugs for anything between 27 to 39 rupees (0.50 to 0.72 dollars) as per the printed price. Thus the patient is at the mercy of the doctor or the pharmacy, and will take whichever drug is recommended to him,” Gurbani explained to IPS.

To counter this practice, the government now buys generic drugs directly from the manufacturers and has “developed infrastructure to hand them over to patients through the 13,874 (approved) drug distribution centres,” Gurbani added.

Patients that are obliged to embark on lifelong drug courses – for conditions like diabetes or heart disease – have hitherto struggled to make their payments.

“A particular brand of medicine used for diabetes costs 117 rupees (2.17 dollars), but we purchase 10 tablets of generic medicines for diabetes at 1.97 rupees (0.036) dollars,” said Gurbani, adding that the difference in pricing certainly did not mean a compromise on efficacy and quality.

Changing lives with free medicine

Gurbani, a former secretary of the Essential Drug List Committee for the Rajsathan state government, says medical expenses are the second most common cause of rural indebtedness in India.

Citing official data, he told the audience at the conference that more than 40 percent of those hospitalised in India needed to borrow money or sell assets in order to afford treatment.

The cost of a single hospitalisation has pushed 35 percent of patients below the poverty line. In fact, unaffordable healthcare has prevented over 23 percent of the sick from consulting a doctor.

The scarcity of medical professionals has contributed to healthcare costs reaching astronomical rates. According to the World Health Organisation, India has just 6.5 physicians to every 10,000 patients. By comparison, China has 14.2 doctors, while Britain has 27.4 physicians for the same number of patients.

The expenditure on drugs alone constitutes between 50 to 80 percent of healthcare costs in India. And all this in a country regarded as the “world’s pharmacy”, Gurbani lamented.

India’s pharmaceutical industry is the third largest in the world with annual production of about 25 billion dollars and domestic sales amounting to 12 billion dollars. India exported medicines worth 13.2 billion dollars in the last fiscal and the government plans to double it to 25 billion dollars by March 2014.

And yet, said Gurbani, “two-thirds of the population do not have regular access to essential drugs.”

Dr. Ravi Narayan, an Indian public health academic who is also part of the All India Drug Action Network, was full of praise for the Rajasthan government’s initiative.

“Rajasthan has a very strong people’s movement and with people like Samit Sharma who heads the RMSC, this was bound to succeed,” he told IPS, on the sidelines of the Beijing symposium.

The runaway success of the Rajasthan model, according to Narayan, has proved that “India is going into the Rajasthan experiment”.

Tamil Nadu, a state of 72 million people, is also providing free medicine for all. Even Karnataka is building on these models, Narayan informed IPS.

With India moving towards universal health coverage (UHC) in the next two years, it has budgeted nearly 300 billion rupees (55.9 million dollars) to fund the programme. It hopes to be able to provide free drugs to 52 percent of the population by April 2017.

The central government will fund 75 percent of the programme, with states doling out the rest.

India’s proposed UHC plan contains many of the features of Rajasthan’s model, such as centralised procurement, regulations to ensure that doctors prescribe cheap generic drugs rather than branded medication, a list of “permitted” drugs and distribution limited to official government health centres.

“It’s not just possible in India, it’s possible all over the world,” said Gurbani.

Obstacles can be overcome

“Conceptually the model has a lot of strength, but it’s difficult from a political perspective. There has to be harmony between the central government and the (28 states and seven union territories) in India,” Abdul Ghaffer, executive director of WHO’s Alliance for Health Policy and Systems Research, told IPS.

With the country’s public health system already under resourced and struggling to meet the needs of 1.2 billion people, 40 percent of whom live below the poverty line, there are serious challenges to expanding the programme nationwide.

There have been occasional shortages of medicines, which Gurbani attributes to the early stages of a project finding its bearings in a geographically diverse region.

“There is the tribal belt as well as the desert and then the urban areas, besides large rural pockets. The needs are different, so at times we ran out of stocks. These teething problems were inevitable; in the course of time, these shortfalls will be eliminated,” Gurbani predicted.

Others at the conference raised thorny questions about the mammoth infrastructure this process will require, hinting that some states may not yet be in a position to set up warehouses and cold storage facilities, or test all the drugs made by roughly 12,000 manufacturers across India.

Foggy details surrounding Europe’s anti-counterfeiting trade agreement (ACTA) have divided pubic opinion, with activists on one end of the spectrum claiming it to be the end of Internet freedom and the generic drug market, while proponents continue to defend the act as a “modest” agreement to protect Europe’s intellectual property.

Such polar opposite opinions shed light on the essential controversy surrounding the ACTA: the lack of detail in the text leaves broad room for interpretation.

The importance of protecting European Union intellectual property is acknowledged by a broad sector of civil society but whether or not the ACTA is the answer remains to be seen, especially given concerns over how the agreement was negotiated and how it will be enforced.

Currently, the draft text is in the hands of the European Court of Justice, which will rule whether or not the agreement is aligned with the rights and freedoms ensured to EU citizens via various treaty standards.

Controversy over the ACTA has unfolded with much drama, including masked protestors taking to the streets in cities all across the continent, culminating in a week’s worth of meetings and forums at the European Parliament during the week of Feb. 27.

When the ACTA’s rapporteur, French parliament member Kader Arif, threw his support behind protestors in late January, it sent a very clear message about the ambiguity of the agreement.

Arif resigned with bold claims that he no longer wished to be part of the “masquerade” of the ACTA, adding that he had encountered political manoeuvres designed to rush the agreement through without due consultation of civil society and limited transparency.

The legislation, he said, would not be effective in its intended purpose of tracking those who profit from counterfeiting, and instead open the door to a host of violations of individual freedoms.

Still, the legislation pushed on.

Karel De Gucht, the EU’s commissioner for trade, said turning the ACTA to the European Court of Justice was a necessary step in order to quell rumors and enter a period of informed debate over the agreement.

De Gucht stressed that the ACTA was designed to protect intellectual property, calling it Europe’s ‘main raw material’.

“The ACTA will change nothing about how we use the Internet and social websites today – since it does not introduce any new rules. The ACTA only helps to enforce what is already law today,” De Gucht said.

But a French citizen online advocacy group, La Quadrature du Net, insists De Gucht is lying to parliament members and downplaying the ACTA’s far-reaching effects.

“By pretending that ACTA is inoffensive, Commissioner De Gucht is trying to hide the European Commission’s immense responsibility in initiating a negotiation process circumventing democratic arenas,” Philippe Aigrain, co-founder of La Quadrature du Net said.

Implications for generic drugs

Amnesty International is urging the EU to reject the ACTA, lamenting that it would infringe upon generic drug distribution by allowing officials to seize drugs with labels similar to trademarked brands.

Similar labels are used in order to communicate medical equivalence, according to Amnesty, and are an integral component in maintaining faith in the generic drug trade.

Scottish parliament member David Martin voiced his concern over the future of generic drugs as well. Though patents themselves are not included in the text, the ACTA leaves room for border patrols in any given country to mistake generic drugs for counterfeit drugs and seize them, which has happened in the past, Martin said.

De Gucht countered this argument by pointing to the very real threat of the distribution of counterfeit drugs; he said that more than 10 percent of generic drugs are counterfeited, placing people in acute danger of consuming drugs with harmful ingredients.

Widney Brown, the senior director of international law and policy at Amnesty International, called the ACTA a “Pandora’s box of potential human rights violations,” with additional mention of concerns over privacy, freedom of information, and freedom of expression.

Besides NGOs, active citizens have taken a firm stance against the ACTA. On Feb. 28, the European Parliament received a petition representing more than 2.4 million people opposed to the agreement.

Sponsored by Avaaz, an online organisation that works to connect civil society with the political decision-making process, the petition called for Parliament to reject ratification of the ACTA, effectively killing the agreement.

“This is not 1984”

In an address to the European Parliament’s committee for international trade, De Gucht stressed that much of the opposition to the ACTA was unfounded, based on false assumptions about the ACTA and an exaggeration of its harmful effects.

“This is not 1984; this is 2012. The ACTA is not about ‘Big Brother’, it is about solving our economic problems in 2012 and beyond. And in 2012 we have real economic problems that we must take action to solve. The ACTA is part of the solution,” De Gucht said.

But the agreement’s current rapporteur isn’t ready to express similar support. Martin, who calls himself the “accidental” rapporteur, appointed after Arif’s resignation, has labeled himself the ideal man for the job, as his indecision over the agreement allows him to view the whole situation with clarity.

Shadow rapporteur Christofer Fjellner also has hesitations about the public’s response to the ACTA, saying that at least “50 percent” of protests against the ACTA are “myths” while the other 50 percent are legitimate concerns worth examining.

Fjellner pointed specifically to a commonly held fear of unwarranted searches of personal devices, such as computers and MP3 players, which he refuted as “ungrounded”.

Though the Avaaz petition labeled the ACTA the “new threat to the net,” the agreement has actually been on the table since 2007.

Formal negotiations were launched in June 2008, and went through 11 rounds of negotiations before being finalised in November 2010. The EU and 22 member states signed the ACTA on Jan. 26 in Tokyo; but in order to take effect the agreement must be universally ratified by all member states and approved by Parliament.

So far, Germany, the Netherlands, Estonia, Slovakia, and Cyprus have withheld support for the pact.

Countries that have pledged support include the United States, Canada, South Korea, Japan, Australia, New Zealand, and Singapore.

Michael Geist, a law professor at the University of Ottawa, spoke at an ACTA workshop on Mar. 1, where he argued that open discussions about the ACTA should have taken place years ago, at the conception of the agreement, instead of at a juncture where Parliament only has the power to approve or reject it altogether.

Uncertainties have been enough to halt the decision making process for now. Neither the European Court of Justice nor the European Parliament has been given a deadline, and the process could be stalled for a year or more.

(END)