Access To Medicines Project

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.
-----

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/.
-----

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.
-----

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.
-----

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.
-----

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.
------

In May 2009, twenty-six U.S. consumer, development, HIV/AIDS, public health and religious groups, including Essential Action, Act UP Philadelphia and New York, Africa Action, CPATH, Forum on Democracy and Trade, Global AIDS Alliance, Health GAP, the Interfaith Center on Corporate Responsibility, Knowledge Ecology International and Oxfam America, released a common platform on trade-related intellectual property and access to medicines issues. The document broadly outlines the common policy agenda these groups are pursuing in the areas of access to medicines, innovation and transparency.

You can download the platform here: IP-MedsPlatformMay2009.pdf

You can download a list describing the organizations that endorsed the platform (including contact persons) here:
OrganizationalDescriptionsofPublicHealthGroupsforUSTR-May13.pdf

Read a text version of the platform in the continuation of this post.
-----

By Peter Maybarduk
The Wall Street Journal
Letter to the Editor

Roger Bate correctly identifies the danger to patients posed by substandard medicines ("China's Bad Medicine," op-ed, May 5). But his article tends to confuse public health and patent and trademark concepts.

One reason this matters is poor drug quality is a much bigger public health problem than just fakes.

Another is that brand-name drug companies, unfortunately, are exploiting public fear of fakes to reinforce patent monopolies -- in some cases demanding public officials treat generic competitor drugs as "counterfeits" that may infringe patents and should be subject to the same aggressive seize-and-destroy tactics applied to fake medicines. Dutch authorities' recent seizure of legitimate generics (which Merck requested be destroyed), in transit to treat HIV/AIDS in South America, is an example.

Whether a drug infringes a patent is an entirely separate inquiry from whether a drug is substandard or otherwise unsafe. Public policy should be careful to maintain this distinction, as overzealous government efforts to anticipate patent infringement can limit access to affordable and lifesaving generic medicines. They can also leave taxpayers footing the bill to protect drug firms' monopolies.

Peter Maybarduk
Essential Action Access to Medicines Project
Washington, D.C.
-----

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.

-----