Country Disputes and Other ...

Earlier this year, Colombian HIV/AIDS groups won major price reductions for the antiretroviral drug lopinavir + ritonavir (Abbott Laboratories' Kaletra) through a compulsory license campaign. While the Colombian health ministry eventually turned down the license request "for now", the campaign moved the government to fix a price ceiling for Kaletra, some 54-68% lower than Abbott's previous prices. The price ceiling should reduce the average annual treatment cost per person by about $2,000 per year.

Nevertheless, reports are surfacing that Chicago-based Abbott may be defying the price order in its sales to some buyers. The National Medicines Pricing Commission (Cnpm), which imposed the ceiling, is investigating. An article this week in El Tiempo , Colombia's largest newspaper, quoted an anonymous knowledgeable source in Colombia's largest healthcare providers association, saying Abbott's prices have not changed. (Officially, the association reported it could not disclose the prices it pays Abbott, due to a confidentiality agreement.) And receipts from a separate source show at least one consumer recently paid prices considerably higher than the ceiling.

Although Abbott has not commented on the reports, it has petitioned the government to revoke the price order.

Health Minister Diego Palacio sent healthcare providers a letter last week concerning lopinavir+ritonavir's new price, saying the state "will prevent any person or company from abusing their dominant position in the market." If the Pricing Commission's investigation reveals Abbott has failed to comply with the price order, it will refer the case to the Agency for Industry and Competition (SIC) to levy sanctions.

Notably, Abbott's refusal to comply with the price order would provide Colombia new and persuasive legal grounds to issue a compulsory license: precisely the anti-competitive conduct cited by Minister Palacio in his letter. In order to maintain credibility and preserve its authority, the Colombian government needs to take swift and stern action. Colombian HIV/AIDS groups will make the case.

The El Tiempo article is available in Spanish in the continuation of this post.
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Today, Essential Action along with eight other civil society organizations, sent a letter to the World Health Organization Expert Working Group on R&D financing (EWG) to express concerns and make suggestions regarding issues of transparency and balance, conflict of interest and substantive outcomes. The expert working group, which is meeting today in Geneva, was created as the third stage of a longer process to address important flaws in the current system of financing medical R&D. The EWG follows the work of the WHO Commission on Intellectual Property Rights, Innovation, and Public Health (CIPIH) and the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG). The overall objective of these initiatives has been to reform and change the current system of R&D financing.

Download a .pdf version of the letter here: ngos2ewg_30jun2009.pdf

You can read a text version of the letter below the jump.
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In June 2009, a paper by Sarah Rimmington and Peter Maybarduk of Essential Action, titled "Compulsory Licenses: A Tool to Improve Global Access to the HPV Vaccine?," was published in the American Journal of Law and Medicine.

Cervical cancer disproportionately affects women in lower- and middle-income countries. But the new vaccines developed to prevent infection with some strains of the human papillomavirus (HPV) that cause cervical cancer are priced beyond the reach of most women and health agencies in these regions, due in part to the monopoly pricing power of brand-name companies that hold the patents on the vaccines.

Maybarduk and Rimmington conclude that compulsory licenses, which authorize generic competition with patented products, could expand access to HPV vaccines under certain circumstances. If high-quality biogeneric HPV vaccines can be produced at low cost and be broadly and efficiently registered, and if Merck and GSK are unwilling to grant licenses on a voluntary basis, compulsory licensing could play a pivotal role in ensuring vaccinations against HPV are available to all, around the world, regardless of ability to pay.

The authors also note that some of the barriers they identify could pose formidable – and perhaps insurmountable – hurdles to the successful use of compulsory licensing of this one particular product (Merck and GSK's HPV vaccines) in the near term. Of particular concern are the possible scientific and regulatory challenges to manufacturing and registering generic HPV vaccines (which are biologic products), and the likelihood manufacturing would in any event be concentrated in very few countries. They point out this last challenge could be eased if more manufacturing countries adopt TRIPS Paragraph 6 legislation, enabling them to export vaccines under compulsory license.

However, though barriers to making and using compulsory licenses to ensure the distribution of low-cost generic HPV vaccines may prove insurmountable in the near term, the analysis provided in their paper can still assist governments, humanitarian organizations and others to evaluate the appropriateness of compulsory licensing as a tool to promote access to other life-saving products. For many products, the hurdles will not be so great. Important examples include the prohibitively expensive newer, second-generation drugs for HIV-AIDS, as well as other traditional, chemical-based drugs aimed at additional diseases, which will not face the manufacturing and registration hurdles unique to biologic products like the HPV vaccine.

The context for every product will necessarily be different. But as brand-name companies intensify global patenting, compulsory licensing as a tool to promote access to affordable medical technology becomes ever more important.


Download a copy of the paper here: Rimmington_Maybardukpaper.pdf

The Inter-American Dialogue asked Essential Action and others to respond to a series of questions on Venezuela's recently announced plans to review its patent system for an article that appears in today's copy of its English-language daily bulletin, "Latin America Advisor." The questions are posted below, as are Peter Maybarduk of Essential Action's responses. If you wish to read the entire article, which also includes responses by David Vivas-Eugui of the International Centre for Trade and Sustainable Development, José Luis Di Fabio of the Pan American Health Organization and Adrian Cruz of Cross Keys Capital, you can download the bulletin here: IADVZprinted.pdf

Inter-American Dialogue's Latin America Advisor
FEATURED Q&A
Will Venezuela Move to Modify Pharmaceutical Patents?

Question
Earlier this month, Venezuela's trade minister said the government was carrying out a review of patents, including those on pharmaceutical products, arguing patents elevate the prices of goods and fill the coffers of multinational corporations. Leaders of Venezuela's pharmaceuticals industry say revoking patents and allowing drug makers in Venezuela to produce patented medications could discourage foreign investment in Venezuela and also cause shortages of medicine. Do you agree? Will more medicine reach the neediest people if patents are revoked? How much do protections for intellectual property rights matter in Latin America's health systems?

Answer: Peter Maybarduk, Essential Action Access to Medicines Project

It’s worth clarifying what the Venezuelan government has and has not said. The government announced plans to review patent rules. Improving public access to medicines and generic medicine manufacturing capacity are key priorities of this review. The government has not yet announced a detailed policy, and statements by some government opponents seem to have exaggerated the substance of the announcements. A clarifying source is Venezuela's intellectual property office, SAPI, which has posted notices on the subject: http://www.sapi.gov.ve/.
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IP-Watch
By David Cronin

BRUSSELS - India’s status as a top world supplier of generic medicines could be threatened by a free trade agreement its government is negotiating with the European Union, a new study has concluded. Separately, the World Customs Organization has abandoned its intellectual property rights enforcement group, replacing it with a non-policymaking information committee.

A draft of the proposed agreement, available here [1], put forward by EU officials recommends that it should incorporate a wide range of intellectual property issues. According to Carlos Correa, a professor in the University of Buenos Aires, at least two of the provisions in the draft could hamper access to affordable medicines for developing countries.

In an analysis of the accord, Correa concluded that it could require India to forbid the manufacture of generic versions of patented drugs for up to five years after the patents in question expire. While the official rationale behind the EU’s proposal is that such an extension would offer compensation for the time it has taken the patent-holder to obtain marketing authorisation for a particular drug, Correa argued that it would have adverse consequences for the poor as it would delay the reduction of drug prices.

Another provision would offer protection to test data submitted for the approval of branded medicines for a certain length of time (the precise duration has not yet been specified by EU officials). In effect, this would bar makers of generic drugs from using that data.

Until now India has been opposed to introducing such a form of data exclusivity, Correa noted, adding that the EU recommendations go beyond the scope of the key international IP law: the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.

The question of access to medicines was one of the main issues debated at a public meeting held in Brussels on 10 June, organised by several consumer and health action groups.

Peter Maybarduk from the Washington-based organisation Essential Action said that a number of studies have estimated that the costs of medicines can fall by between 40 percent and 80 percent once generic versions of patented drugs become available. Despite the health benefits associated with this reduction, he complained that a number of governments from industrialised countries have been pursuing an “enforcement agenda” which places greater emphasis on the profits of corporations than on public needs.
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On May 22, 2009, Colombian civil society organizations learned that the Colombian Ministry of Health decided not to declare access to HIV/AIDS medicine lopinavir + ritonavir (LPV/r) a matter of public interest. The ministry's decision halts government consideration of a compulsory license request, initiated in July 2008, that would introduce price-lowering competition with Kaletra, Abbott Laboratories' brand-name version of the drug.

Colombian networks of people living with HIV/AIDS are criticizing the health ministry's process in considering the request – which seems to have deeply engaged Abbott while excluding treatment advocacy groups and the organizations that filed the request – and are describing the decision as a missed opportunity to work toward the U.N. Millennium Development Goals.
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Scrip News
By Francesca Bruce

The Colombian government will not be declaring Abbott's antiretroviral Kaletra (lopinavir plus ritonavir) to be of public interest, leaving the patent on the product intact until 2016. Civil society has accused the government of putting politics first.

The decision comes soon after the government set a price ceiling for Kaletra (scripnews.com, May 13th, 2009). NGOs had been pushing for the government to declare the drug to be of public interest and to issue a compulsory licence, claiming that Kaletra's high price barred access to the drug (scripnews.com, July 29th, 2009). However, the government rejected this, largely on the grounds that all patients who required Kaletra were covered by some sort of health insurance and did not have to pay for the medicine. This was also one of the main arguments put forward by Abbott, according to the government in its justification for the decision.
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Under sustained pressure from civil society groups to grant a compulsory license, the Colombian government has issued an order establishing maximum prices for Abbott Laboratories' HIV/AIDS medicine Kaletra (generic name LPV/r or lopinavir/ritonavir). The order sets a price ceiling of $1,067 per person, per year for Kaletra sales to the public sector, and $1,591 for the private sector, down from around $3,400 and representing average price reductions around 54% - 68%. The order, signed by the Health and Commerce Ministers as well as the Office of the President, follows unsuccessful efforts to negotiate better prices from Abbott.

Meanwhile, the Colombian Health Minister is expected to announce later this week whether the Health Ministry finds access to LPV/r to be in the public interest – a finding that should lead automatically to a compulsory license. A compulsory license would authorize generic competition with Abbott's patented product. New Clinton Foundation agreements with three generics firms offer LPV/r in partner countries for $470, and Peru recently obtained LPV/r from Eske Group – a Cipla affiliate – for the low price of $396.

The price ceiling is a direct result of public pressure for a compulsory license. And competition remains the only way Colombia can access the far better generics prices, and ensure prices continue to fall with time. Deep cost savings would enable health programs to scale up treatment, and come closer to universal coverage.

Concerned their government might be content with its price action, Colombian civil society groups are arguing a still-expensive monopoly is no substitute for competition, and demanding the government issue a compulsory license as proposed.

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Essential Action, Knowledge Ecology International (KEI), Oxfam America,
AU Program on Information Justice and Intellectual Property (PIJIP),
Forum on Democracy and Trade, Health GAP (Global Access Project)

FOR IMMEDIATE RELEASE | April 30, 2009
Contact Information for each organization accompanies quotations below

Today, the US Trade Representative (USTR) released its annual "Special 301 Report," identifying countries it views as denying "adequate and effective protection of intellectual property rights." Despite committing to the World Trade Organization's TRIPS flexibilities meant to encourage access to low-cost generic medicines, the United States regularly singles out countries for pro-health policies that are TRIPS compliant in the Special 301 Report. The report is based on comments submitted to USTR, most of which come from businesses holding copyrights and patents. The pharmaceutical industry's trade association submits detailed comments each year, which USTR draws on extensively. (To view all the comments received by USTR for the 2009 report, see www.regulations.gov).

Public health and consumer groups had hoped the Obama administration would turn a new page and recognize the right of countries to take TRIPS-compliant measures that increase access to medicines, and thus are disappointed that this year's report mirrors not only Big Pharma's demands, but the policies previously pursued by the Bush administration.
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A Tug-of-War, A Funeral, and Drug Prices

By Antigone Barton | Wednesday, August 6, 2008, 03:05 PM
Palm Beach Post
[Intenational AIDS Conference Blog]

MEXICO CITY — This morning we had a funeral procession at the International AIDS conference, complete with a black-draped coffin followed by sobbing, wailing, black-robed people wearing ghastly white masks and carrying signs chastising pharmaceutical company Abbott for causing the death of their loved one, “Por Falta Katetra.” (Of Lack of Kaletra)

Kaletra (generically it is called lopinavir/ritonavir) is one of the best drugs around for AIDS patients, activists say, with few side effects, low resistance build-up, and it doesn’t need to be refrigerated, which is critical in the hot climates where the epidemic has rampaged.

But Abbott keeps it expensive, and that makes sustaining treatment as well as enrolling more patients for treatment difficult. Abbott’s reluctance to negotiate its high prices has kept the company in the sights of treatment access activists for years. Attendees at the 2004 International AIDS Conference in Bangkok still recall how the drug company’s posh booth in the exhibit hall disappeared, suddenly, just one strip of paper left waving pathetically from a remaining support brace.

No one can recall an Abbott booth at the Toronto conference, although the company bought space there, and activists can’t find one this year.

This morning’s funeral however, was followed by an afternoon “tug-of-war,” with patients living with HIV and in need of Kaletra on one side, and the pharmaceutical giant on the other.