Compulsory Licenses: A Tool to Improve Global Access to the HPV Vaccine?

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

Will Venezuela Move to Modify Pharmaceutical Patents?

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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Over the last ten years, generic competition worldwide has produced a revolution in HIV/AIDS treatment, reducing prices from $10,000 to near $100 per person per year, and enabling more than three million people to access lifesaving antiretroviral therapy. Competition and domestic manufacturing have helped Brazil save $1 billion since 2001, and develop one of the world’s most effective HIV/AIDS treatment programs.

Multinational drug companies, based almost exclusively in northern countries, routinely use patent monopolies on key medicines to keep prices at high, anti-competitive levels – often too high to enable widespread treatment, including throughout Latin America.

There are several tailored ways Venezuela could improve access to medicines while contributing to pharmaceutical research and development costs, and complying fully with domestic laws and WTO patent rules. For example, by issuing compulsory licenses, Venezuela could authorize generic competition with specific patented medicines, in exchange for reasonable royalties to the patent holder.

It is not true the Venezuelan pharmaceutical industry uniformly opposes revisions to patent rules. The generics chamber CANAMEGA publicly supports revisions, and domestic manufacturers would benefit from flexibilities allowing them to produce more medicines.

Targeted reforms to Venezuela’s patent system could protect international investment incentives, while also improving market efficiency, increasing investments in innovative research and development – and supporting access to medicines for all.

Civil Society Sends Letter to WHO Expert Working Group on R&D Financing re Transparency and Balance, Conflicts of Interest and Outcomes

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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June 30, 2009

Dear members of the WHO Expert Working Group on R&D Financing

The WHO Expert Working Group on R&D financing (EWG) 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 CIPIH and the IGWG. The overall objective has been to reform and change the current system. We are writing to express our views regarding transparency, conflicts of interest and EWG outcomes.

1.Transparency and balance

There are no publicly available procedures outlining how EWG will conduct itself. For example, there are no rules for the conduct of meetings and those invited to attend.

The WHO Expert Working Group is this week holding its second non-public meeting. The first meeting in January 2009 was held without advance notice, was not open to the public, and featured attendance and presentations from selected stakeholders, including the pharmaceutical industry, the Gates Foundation and several groups funded by the Gates Foundation – groups that generally share similar views, and which collectively can be said to represent the status quo. There has not been any opportunity for those holding other views to address the EWG meetings directly.

The mode for evaluating proposals is highly secretive. There is little known about which consultants have been hired. The EWG should identify which WHO staff or consultants have been hired to evaluate proposals, and be more open about the proposed criteria, as well as its own meeting schedules and agendas.

While we recognize the need for the EWG to hold non-public sessions, the approach to obtaining stakeholder input should be transparent, participatory and reflective of all views.

There are a number of alternative models to address these concerns for example the public sessions held by the CIPIH.

2.Conflicts of Interest

There are no public procedures on how EWG will address conflicts of interest. This is a critical issue as there are many opposing views.

The pharmaceutical industry, product development partnerships (PDPs) and academic and other non-profit research institutions all will be vying to be recipients of new money for medical R&D. As such, there will be incentives to skew EWG outcomes to favor their institutions. The EWG needs to recognize this, and adopt policies to manage the risks presented by conflicts of interest.

There is also an unusual set of conflicts of interest presented by the Gates Foundation. Today the Gates Foundation is the primary source of funding for many important areas of research and development for neglected diseases, and is also active in setting R&D priorities and norms for a wide range of R&D activities, including the management of intellectual property.

While recognizing and applauding the tremendous good that the Gates Foundation does in many areas, it is also necessary to address openly the fact that in the area of norms for intellectual property, priority setting, and sustainable financing mechanisms, the Gates Foundation is known for supporting proposals and policies that are at odds with some of the most controversial reforms explored in the CIPIH and IGWG processes.

Another recent example of the need for clarity on process and conflicts is the proposal to engage the George Institute to undertake a comparative review of alternative incentives, which will include the establishment of a stakeholder network . In at least one draft, this network would consist of 9 pharmaceutical companies and trade associations, 8 organizations that consist of the Gates Foundation or research organizations funded by the Gates Foundation, 7 government agencies from OECD countries, 5 government agencies from developing countries, and only one NGO critical of the status quo. Such a network would incorporate an unacceptable lack of balance, have many conflicts of interest, lack legitimacy, and be highly unlikely to recommend anything that would represent significant changes.

In addition the proposal mixes into one process, on the one hand core functions of the EWG and stages of review — e.g identification of incentives, establishing the framework for review of submissions, review and short listing; and, on the other the desire to obtain buy-in from certain stakeholders. As a result it gives certain stakeholders privileged prior input into the thinking of the EWG and a key role in setting the parameters for discussion.

3.Substantive Outcomes

It is our view that any proposals in the EWG process should meet the following standards, particularly in light of the recommendations of the CIPIH report and the Global Strategy and Plan of Action.

Sustainable systems of finance for medical R&D, including both sources of funding and possible incentive mechanisms, should be:

1)transparent
2)cost effective, and
3)ambitious enough to address real needs for innovation, and
4)include government funding,
5)require, when possible, open licensing of inventions and other IPR in developing country markets,
6)encourage or require open access to data, material and knowledge,
7)foster the transfer to and development of technology in developing countries,
8)condition financing to requirements for access requirements,
9)promote a range of incentive schemes for research and development including addressing, where appropriate, the de-linkage of the costs of research and development and the price of health products,
10)when possible ensure sustainable and competitive supply of products from generic producers in developing countries, and be
11)accountable to governments and democratic processes.

4.The biomedical R&D Treaty

The recent World Health Assembly, agreed that the EWG should appropriately consider this issue, and report to the WHO. It is very important that the EWG review the proposals made for future discussions regarding a biomedical R&D treaty, including whether to consider recommending that the WHA revisit the question of the WHO role as a stakeholder in discussions about a biomedical R&D Treaty.

Concluding comments

Thank you for considering our comments on these issues and we look forward to your response.

(Groups listed in alphabetical order)

Sincerely:

Jonathan Berger, Senior researcher and head of policy & research: AIDS
Law Project, South Africa

Dr. Oscar Lanza V. Coordinador AIS Bolivia

Luis Villarroel, Director of Research, Latinoamerican Center of
Intellectual Property Research for Development, CORPORACION INNOVARTE

Robert Weissman, Director, Essential Action

German Holguin, Director General, Fundación Misión Salud, Colombia

Tim Reed, Director, Health Action International

Francisco A. Rossi. B. Fundación IFARMA-AIS Colombia

James Love, Director, Knowledge Ecology International

Ethan Guillen, Executive Director of Universities Allied for Essential
Medicines

cc: Sir George Alleyne, Chair, WHO Expert Working Group on R&D Financing
cc: Dr. Elil Renganathan, WHO Executive Secretary for Public Health,
Innovation and Intellectual Property.

Press Release: IP enforcement initiatives threaten consumer rights and public health

The TransAtlantic Consumer Dialogue (TACD), Health Action International (HAI) and Knowledge Ecology International (KEI) hosted a public meeting on the issue of intellectual property rights enforcement in Brussels on Wednesday, June 10th.

Every day we hear about counterfeiting and piracy and about anti-counterfeiting and new enforcement initiatives of governments and industry. HAI, KEI and TACD presented two panels that challenged the direction and rationale of several of these intellectual property rights initiatives, including EU regulation 1383 on border measures and the proposed “Anti-counterfeiting” trade agreement (ACTA). The enforcement of private intellectual property right claims is a complex and important area of public policy that touches on issues such as personal privacy, civil rights, freedom, social and economic development, among others.

European Union leaders and the United States government are currently engaged in efforts to shape global norms for the enforcement of copyright, trademarks, patents and other intellectual property rights. These discussions are taking place in multilateral, plurilateral, bilateral and unilateral fora. Such policies raise concerns because of the delicate balance between on the one hand rights and exceptions, put in place by the international copyright and patent law “acquis”, and on the other hand public health principles such as access to medicines.

Speakers at the event represented consumer and public health organisations from both sides of the Atlantic: Médecins Sans Frontières (MSF), KEI, Essential Action, Electronic Frontier Foundation (EFF), HAI, The European Consumers Organisation (BEUC) and the Brazilian Permanent representation to the European Union, as well as respondents from DG-Trade and DG-Internal Market & Services. The diverse audience included representatives from pharmaceutical, seed, and software companies, the US Chamber of Commerce, academic experts, European Commission officials, members of the European Parliament, journalists, public health groups, consultants, business and civil society organisations.
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Selected quotes by the speakers:

Alexandra Heumber, MSF
“Patent infringement should be excluded from the EU regulation 1383/2003 in order to avoid seizures of legitimate generic medicines in transit.”

“Regulation 3295/94, the law preceding 1383/2003, was much narrower in scope. Rather than including all violations of intellectual property, it focused on counterfeit and pirated goods, which are generally seen as trademark issues. The updated, broader law is problematic as we have seen no justification for the extension to this area and no impact assessment of the effects.”

Eddan Katz, EFF
“At a time when carefully considered public policy is critical for protecting the growth of the knowledge economy, the ACTA negotiations brazenly obscure decision-making in secret meetings outside of public debate and without legislative accountability. The leaked provisions reveal a global information customs regime with radically broad powers for border officials and a grab bag of multi-national corporate lawmaking. As the Internet section is in the process of being mapped onto this border customs pact, the urgency of meaningful public debate demands a release of this ill-considered text.”

Anne-Catherine Lorrain from TACD announced at the meeting that the French Constitutional Court censored the graduated response proposal. The French Court echoed “Amendment 138” of the Telecoms Package voted by the European Parliament, saying that cutting access to the Internet is a sanction that can only be imposed by the judicial authority, taking into account the rights of defense and the presumption of innocence.

James Love, Knowledge Ecology International
“In a plethora of settings, publishers and pharmaceutical companies are pushing an aggressive new agenda to expand and enforce intellectual property rights. The proposals are often advanced in undemocratic and non-transparent fora, such as the top secret and highly classified ACTA negotiations. This is big government and big business at its worst, creating rules without input or sensitivity to the concerns of consumers, overriding civil rights, undermining privacy, increasing prices to consumers. The topics under review are not simple technical issues or directed at organized crime, they are big sweeping changes in our basic freedoms, and underhanded attempts to give lobbyists rules they can’t get in a normal democratic setting.”

Peter Maybarduk, Essential Action
“Many new worldwide measures aggressively protect pharmaceutical monopolies under the guise of fighting counterfeits -­ blocking competition and jeopardizing global access to medicines in the process. For example, the secret, so-called Anti-Counterfeiting Trade Agreement – which in fact focuses on ratcheting-up patent, copyright and trademark protection, with little if any attention to drug quality – deliberately misrepresents its contents to consumers, and is therefore itself counterfeit. Counterfeits are a subset of a much larger drug quality issue. The enforcement agenda fails to address broader quality concerns, and indeed may divert much-needed public health resources away from strengthening drug regulatory authorities. Rather than investing taxpayer dollars enforcing private rights, public bodies should promote price-lowering competition, drug quality and affordable access to medicines.”

Henrique C. Moraes, Brazilian Permanent representation to the EU
“There are ‘TRIPS Plus’ initiatives emerging in fora where these kind of discussions are not expected. Public Interest organisations should be aware of this.”

Kostas Rossoglou, BEUC
“BEUC calls on decision makers in Brussels not to give in to the wish of the content industry to control the Internet. There remains confusion – whether deliberate or not – between consumers and organized operations, whereby consumers are blamed for copyright infringements. Clarification is needed: applying the same enforcement measures to both commercial scale infringers operating for profit and to individual citizens is, at a minimum, disproportionate. While consumers have been actively engaging with the technology and what they can do with it, it is disappointing that many producers and owners of content in the creative industry sector have seen the technology as a threat rather than a business opportunity.”

A Swedish participant at the meeting referred to a quote by MP Johan Linander, Legal affairs spokesperson of the Swedish Center Party, saying “If any of the other negotiating countries still would choose to put a stop to openness, Sweden and the EU will have to seriously consider stopping the negotiations altogether”. This quote is thought to be in reaction to the recent success of the Pirate Party in the European elections.

Panel: EU Accord Threatens India; World Customs Body Scales Back IP Enforcement

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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He cited the Anti-Counterfeit Trade Agreement (ACTA) that the EU, the US, Japan and Switzerland decided to negotiate in 2007 as an example of how several different IP issues are being conflated. There is no clear, universally-accepted definition of what constitutes counterfeiting, he suggested. Whereas the TRIPS agreement focuses on violations of trademarks, the World Health Organization is more concerned with deliberate attempts to mislead consumers about the safety of medicines.

Because of the confusion resulting from this lack of clarity, a number of fallacies have gained currency, he said. “Fallacy number one is that any infringement [of IP rights] can be loosely considered a counterfeit or a pirated good,” he added. “Fallacy number two is that similar remedies can be applied for infringements of distinct rights. And fallacy number three is that aggressively combating alleged IPR [intellectual property rights] infringements protects public health.”

Alexandra Heumber, an access to medicines campaigner for Doctors Without Borders/Médecins Sans Frontières, protested at the series of seizures of generic medicines that have occurred in EU ports in recent times. Seventeen seizures of generic medicines, almost all of which were being shipped from India, occurred in the Netherlands during 2008, according to information released by the Dutch authorities, while a similar seizure also took place in Germany’s Frankfurt Airport last month. In every instance, the medicines were destined for developing countries.

Heumber argued that EU rules set in 2003 give customs authorities the power to intercept legal medicines in cases where it is suspected that an infringement of a patent may have occurred. She urged the EU’s executive branch, the European Commission, to issue new guidelines making it clear that such seizures should not be applied to generic medicines.

“While the seizure of counterfeit drugs is understandable, the seizure of legitimate drugs in transit is not acceptable,” she said.

Patrick Ravillard, a trade official with the Commission, said that his institution does not “make any confusion between generic medicines and fake medicines.” Stating that the EU is committing to boosting access to medicines for the poor, he said that assurances have recently been given by Europe’s leading pharmaceutical firms that they will not invoke EU rules to request the seizure of generic drugs. Such assurances are “very positive,” he claimed.

James Love from the organisation Knowledge Ecology International attacked the lack of transparency surrounding the ACTA negotiations. Documents under discussion and even the names of those taking part in the talks have been withheld from the public. He also suggested that leaks from the talks indicate that the title ACTA is something of a misnomer. Rather than being confined to matters of counterfeiting, the talks are dealing with a variety of other intellectual property issues, with the EU even seeking to place geographical indications (terms such as Bordeaux or Champagne that belong to food or drink from particular locations) on the agenda.

WCO Scales Back Policymaking on IP Enforcement

Meanwhile, Brazilian diplomat Henrique Moraes said that public interest groups should be wary of a phenomenon known as “forum-shopping” by governments where IP issues that have been rejected in one institution appear on the agenda of another.

The little-known World Customs Organization, he noted, has been discussing proposals aimed at allowing customs authorities throughout its 174 member countries to seize goods in transit when it is suspected that patents may have been breached. Such provisions went beyond the scope of TRIPS, he added.

Protests raised by Brazil and some other developing countries appear to have paid dividends, he added. During discussions held last week, it was agreed that the WCO will replace its working group known as SECURE (Standards to be Employed by Customs for Uniform Rights Enforcement) with a new internal body. Unlike SECURE, its successor, the counterfeiting and piracy group, will be restricted to exchanging information on how customs officials deal with IP issues and will not have a mandate to set norms or decide on best practices.

[1] http://www.bilaterals.org/article.php3?id_article=14864

Colombian Government Refuses Request to Issue Compulsory License on Expensive HIV/AIDS Drug

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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The government argues insurers are required to provide Kaletra to those who need it, and so price is not a primary factor impeding access. But Kaletra’s high price passes on unnecessary costs to consumers, taxpayers and people living with HIV/AIDS, and diverts healthcare investments from critical priorities – for example, access to other needed medicines and universal HIV/AIDS coverage. Colombian civil society groups also note high medicine prices exacerbate inefficiencies and failures in the health and insurance systems, and make it too expensive to find alternatives when coverage failures do occur – therefore prices do impede access to treatment.

The decision also follows a government order establishing maximum prices for Kaletra at $1,067 per person, per year for the public sector, and $1,591 for the private sector, down from around $3,400 and representing average price reductions around 54% – 68%. This price ceiling is a direct result of the compulsory license request, and according to government figures will save the healthcare system about $10.2 million U.S. per year.

Price, then, clearly does matter to the Colombian government – just not enough to challenge Abbott’s monopoly. At least, in the ministry’s words, “for the moment.”

The announced price reductions are significant, represent an overdue challenge to Abbott’s pricing practices, and signal a positive shift in civil society groups’ ability to influence health policy.

But the health ministry seems to be treating monopoly price reduction as a substitute for competition. It is inadequate in this regard. New Clinton Foundation agreements with three generics firms offer LPV/ r for $470, and Peru recently obtained LPV/r from Eske Group – a Cipla affiliate – for the low price of $396. Colombia will continue to pay considerably more than a competitive market would bear. Further, Colombia’s new public sector price – roughly equivalent to Abbott’s monopoly price in other regional markets – applies to only a small percentage of Colombia’s market (possibly, it seems, even less than 8%). In practice, Colombia will continue to pay more than its neighbors, even those that share the dilemma of an Abbott monopoly.

To date it is unknown whether Abbott has agreed to sell Kaletra at Colombia’s new price. Competition remains the only way Colombia can access the far better generics prices, and ensure prices continue to fall with time. Deep cost savings enable health programs to scale up treatment.

To that end, the Colombian HIV/AIDS groups have called for supervision of savings obtained through the price reduction, and concomitant investments in sectors of the medicines provision system most prone to failure.

Colombian treatment advocates richly deserve congratulations, and thanks, for significantly reducing Abbott’s prices and shaking up Latin America healthcare politics. They’re not content with this, though – the groups are already investigating avenues of appeal and further proposals to introduce generic competition.

To download the Colombian health ministry’s decision (Resolución 001444 – in Spanish), click here: Resolucin01444Kaletra8-05-09DEFINITIVA.doc

To download the Annex to the decision document (Technical Committee Report – in Spanish), click here: Resolucin01444ANEXODEFINITIVO.doc

Colombian civil society groups’ analysis and press release regarding the decision (in Spanish) can be viewed on the web here, or downloaded here: ColombianCivilSocietyResponse052609.doc

An archive of articles on the compulsory licensing request (in Spanish) can be found here.

Colombia says no to Kaletra compulsory licence

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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Antiretrovirals (ARVs) are included on Colombia’s essential medicines list, and all health insurers – public and private – must offer these drugs. However, in Colombia there is no single ARV purchaser and different public and private institutions compete within the national health system. This leads to wide price discrepancies throughout the country, say civil society organisations.

The cost of the drug creates barriers to access, while having health insurance does not automatically give access to the ARV, maintains RECOLVIH, which represents the organisations petitioning for a compulsory licence. For example, problems arise when HIV/AIDS patients lose their jobs and also when there are delays in provision. The high level of stigma and bureaucracy involved in accessing ARVs can also deter patients from following their regime.
The government also went on to say that the main problems hindering access were to do with failures within the health system, including reaching vulnerable populations or providing adequate diagnosis. Such issues did not merit declaring the drug to be of public interest, it said.

Added to this, the financial impact of declaring the drug to be of public interest was unclear and difficult to calculate, the government said. However, this was poor reasoning, Peter Maybadurk, a spokesperson for the NGO Essential Action, told Scrip. “The government has decided not to save more money, but to protect Abbott’s monopoly,” he said. Although RECOLVIH estimates that the price ceiling will save the government around $10 million each year, greater savings could have been made through introducing competition, he said. “Competition could lead to even lower prices, which could free up more resources to eliminate other barriers,” he added. RECOLVIH accuses the government of ignoring societal needs and basing its decision on politics. Colombia is in the middle of negotiating a free trade agreement with the EU, alongside Peru and Ecuador. It is also waiting for the US to ratify a bilateral FTA.

Moreover, the civil society groups behind the move were not given the chance to participate in the process, said Mr Maybadurk. “During the whole process, which began a year ago, the government never allowed HIV/AIDS patients to participate in the negotiation process to arrive at the price recently negotiated,” says RECOLVIH. Abbott’s involvement in the process is unclear.

Abbott declined to comment. Kaletra is patented in Colombia until December 2016. INVIMA, the medicines regulator, rejected applications from Ranbaxy and Focus Pharmaceuticals to register generic versions of the combination product.