Access To Medicines Project

On October 26, 2009 Ecuador’s President Rafael Correa declared access to priority medicines affecting the health of the Ecuadorean population to be a matter of public interest. Under Andean Community law, the declaration opens the door to competition of generic medicines with patented brand-name drugs, through use of an internationally recognized legal mechanism called compulsory licensing. The declaration could lead to government policies that expand access to medicines.

You can download a .doc version of an unofficial English translation of the declaration here: Decree_CorreaEnglishunofficialtranslation.doc

Dear Colleagues,

On Monday October 5 I wrote you about Ecuador’s plans to expand access to medicines by issuing compulsory licenses, and about President Correa’s vision for intellectual property “as a mechanism for development for the people” (see my post at the bottom of this email for a reminder and an excerpt of President Correa’s comments). Compulsory licenses authorize generic competition with patented medicines, reducing costs and enabling more people to access treatment. Discussions on a compulsory licensing administrative framework are advancing in Quito. This is a critical moment in the discussion, and we would like to show President Correa he has the support of the access to medicines movement.

Essential Action is collecting signatures in support of President Correa’s vision, and reiterating the benefits of TRIPS-compliant compulsory licenses. See our letter below. If you would like to sign on, please send your organization’s name (or your name and organizational affiliation, if any, if you would like to sign on as an individual), your mailing address and email address to . For organizations and individuals able to arrive at a decision quickly, we would appreciate your signature right away – by this Sunday October 11th if possible. The outside deadline for sign-ons is Wednesday, October 21. Please feel free to send me any questions you may have.

Thank you,
Peter Maybarduk
Essential Action

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Economista Rafael Correa Delgado
Presidente de la República

Dear President Correa,

We, organizations of civil society, treatment advocates, development advocates, people living with HIV, and access to medicines movements the world over, congratulate Ecuador on its courageous plans to grant compulsory licenses for medical patents.

Over the last ten years, competition of generic medicines with branded medicines has fueled a revolution in HIV/AIDS treatment. Competition has reduced costs of first-line antiretroviral therapy by over 98%, from $10,000 per person, per year to near $100 today. As a result, four million people worldwide now have access to life-saving drugs.

But monopoly drug pricing problems in developing countries extend far beyond first-line HIV/AIDS treatments. Many people living with HIV and AIDS are graduating to second and third-line treatments, many of which are patented and sold at high cost. Heart medicines, cancer medicines, medicines against opportunistic infections and more are also often sold at prices far beyond peoples’ ability to pay. High costs constrain the essential services public health programs could otherwise provide. Today, multinational pharmaceutical companies are intensifying their global registration of patents. We confront the deadly prospect of monopolized drug markets.

Compulsory licensing is, has been, and will be an essential safeguard of competition. Each country that uses this safeguard – enshrined in the World Trade Organizations’ TRIPS Agreement –makes it simpler for the next. As compulsory licenses open markets to competition, they also help generate the necessary economies of scale to further reduce costs, and incentivize the broader reach of generic medicines. While advancing access to medicines imperatives, compulsory licensing is compatible with ensuring reasonable compensation for patent holders and supporting medical innovation.

The example of Brazil is telling. Since 2001, Brazil has provided hundreds of thousands of people with HIV/AIDS treatment and saved more than US$1 billion through a combined approach of national production of medicines, imports of generics, negotiation and compulsory licensing.

As so eloquently stated in the Political Constitution of Ecuador, Article 363, in access to medicines, the interests of public health prevail over those of mere profit. Your recent remarks position Ecuador to advance the politics and principle of access to medicines for all, in Latin America and around the world.

We stand with you. Please count on our support as you pursue your vision of intellectual property as “a mechanism for development for the people.”

Sincerely,

[the undersigned]
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In July of this year, Ecuador’s President Rafael Correa articulated a vision of intellectual property as “a mechanism for development for the people.” His speech before a live audience on the nationally televised program “Enlace Ciudadano” (“Citizen Connection”) announced a new state policy of using compulsory licenses to improve access to medicines.

I’ve translated an excerpt below. The clip is available (in Spanish and sign language) on YouTube here, as well as the homepage of the Ecuadorean Intellectual Property Institute (IEPI, Ecuador’s patent office), here.

Last week, President Correa announced plans to use compulsory licenses to facilitate the domestic production of medicines. Here is the story in El Universo, courtesy of Judit Rius Sanjuan.

Correa, an economist recently elected to a second term (with a simple majority and a twenty-three point lead over his closest competitor), has charged high-ranking officials in his administration to implement the policy.

Nevertheless, we have heard reports of multinational pharmaceutical companies organizing behind the scenes to disrupt the licensing policy before it can take effect. To realize President Correa’s vision, Ecuador needs the support of the global access to medicines movement.

To show your support and find out how you can help, write:

Essential Action, [email protected] and

Health Action International Ecuador, [email protected]

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From “Enlace Ciudadano,” July 16, 2009:

“Therefore, the subject of intellectual property is tremendously important. What is our vision? When something has been invented or discovered, the more people that use it, the better. For example, a medicine. We’re talking about human rights. Do you think it’s ethically sustainable that if a cure for cancer is invented, people could continue to die because they don’t have the resources to pay? That because the medicine has a registered property right, and because I, Laboratory X, invested in its development, you have to pay me $2,000 for each pill?

This cannot be. When making the [gestures to indicate a “single”] pill costs far less. And it’s to save lives. Especially in these situations, we have to change our conception of property; the traditional conception, the neoliberal conception. Compañeros, we are discussing all of this.

There is, in our legislation, what they call compulsory licensing. I, as President, can order that we issue a compulsory license for Brand X, so they can copy this medicine and make generics, and the people have access to this medicine, to health, to a cure for their illness. [Applause.] And this is exactly what we are going to begin to do, with respect to medicines, with respect to agrochemicals, with respect to everything possible.”

. . . [Correa addresses non-profit motives that also drive innovation (“vocation” and “dedication”), and cites universities as key centers of research and innovation in the public interest.] . . .

“Intellectual property is a mechanism for development for the people. This is our vision of intellectual property. It’s not a mechanism to enrich the pharmaceutical or agrochemical companies. It’s a mechanism for development for the people.”

San Mateo County Times/ Bay Area News Group
The Insider

Consumer groups are still hoping to persuade Congress during this month’s health care reform negotiations to make it easier to create generic versions of drugs known as biologics.

Biologic drugs are created through biological, as opposed to chemical, processes — researchers use plant and animal cells to grow new molecules. They are far more complex than most chemically produced drugs and much harder to duplicate. The top-selling biologics include cancer drugs such as Avastin and several drugs used to treat rheumatoid arthritis and anemia.

Rep. Anna Eshoo, D-Palo Alto, authored an amendment, which was added to the House version of the health care reform bill in July, that would grant biotech firms a 12-year period of market exclusivity on biologics, more than twice the 5-year period that other drugs receive. A similar measure is in the works in the Senate.

Critics charge Eshoo with selling out the public on behalf of the biotech industry, a powerful special interest on the Peninsula and a major contributor to Eshoo’s campaigns. Eshoo claims she’s trying to balance the interests of consumers and biotech companies, which spend billions developing these drugs.

Sarah Rimmington, an attorney for consumer group Essential Action, called Eshoo’s amendment an “unjustified price gouge of the American public.” She said 12 years of market exclusivity is far too long and called into question the pharmaceutical industry’s claim that biologics are far more expensive to produce than other kinds of drugs.

Rimmington also blasted a clause in the amendment that critics claim would allow biotech companies to restart their 12-year window every time they make minor adjustments to their drugs — combining two types of drugs, for instance, or providing them in different doses — a process known as “evergreening.”

Consumer groups were recently joined in the biologics fight by student groups, including the American Medical Student Association and Universities Allied for Essential Medicines. In a statement issued by the student groups on Monday, Yale University medical student Sara Crager said that, as a future biomedical researcher, “I want the fruits of my research to be available as widely as possible as soon as possible.”

Eshoo’s office disputes the notion that biologics are no more expensive to produce than other drugs. The 12-year window is based on the average amount of time a biologic stays on the market before its patent expires, staffers say.

If biotech companies sink billions into biologics research, only to see generic versions, or biosimilars, appear on the market too quickly, they will lose their incentive to do that research, slowing down the development of potentially lifesaving drugs, proponents of the amendment argue.

Pharma Times
By Lynne Taylor

US campaigners yesterday urged Congress to create a “real” regulatory pathway for generic versions of biologic drugs, but researchers warn that it may take until 2011 to implement any such policies.

Current proposals for a regulatory pathway for generic biologics – also known as biosimilars, biogenerics or follow-on biologics – in Senate and House healthcare reform bills will actually block production of most generic biologics, but if these are improved in critical ways they could save $71 billion or more in the first decade alone, say the consumer and medical student groups which are leading the campaign.

The proposals, originating from Representative Anna Eshoo House bill HS 1548 and past bills in the Senate, would provide 12 years’ market exclusivity for biosimilars compared to five years for other drugs. However, the campaigners point out, the Pharmaceutical Research and Manufacturers of America (PhRMA) puts development costs for biologics at $1.2 billion, close to that for conventional drugs at $1.318 billion, and that the Federal Trade Commission (FTC) recommends zero years market or data exclusivity for biologics, given that biosimilars will cost more to bring to market for generic manufacturers than conventional generics, leaving originator companies with 70%-90% of the market.

These proposals will also allow “evergreening,” whereby pharmaceutical companies will be allowed additional 12-year periods of exclusivity for “relatively inexpensive minor tweaks” which, they say, could block price-lowering generic competition indefinitely.

The language in these bills creates biologic drug monopolies, which discourage innovation and raise costs for the US health system, say the campaigners. However, they add that these problems can be addressed by adopted the relevant sections of bills introduced by Representative Henry Waxman (HR 1427) and Senator Charles Schumer (S 726), which would allow five years’ exclusivity and block evergreening.

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Biologics are the fastest-growing segment of the drug market, are predicted to be 50% of new drug approvals soon and include most vaccines and treatments for cancer, multiple sclerosis and rheumatoid arthritis. Already, the top six biologics make up over 40% of expenditures for the Medicare prescription drug programme, the campaigners add.

Meantime, researchers in the current issue of the British Medical Journal (BMJ, September 19, vol 339) warn that “unless biological therapies can be made more affordable, western health care systems face a financial crisis.”

Demand for biologic therapies is enormous, clinicians are prescribing them at increasing rates and pressure is growing to use them earlier in disease progression, say the authors, consultant physician Fraz Mir and student Christopher Kelly of Addenbrooke’s Hospital in Cambridge, UK. However, they add that potential generic manufacturers face a number of major hurdles, not least the fact that development of a biosimilar costs about £120 million compared to £1-£2.5 million for a small-molecule generic. Moreover, while US President Barack Obama’s first budget in February included proposals for an abbreviated regulatory pathway for biosimilars, it may take until 2011 for the Food and Drug Administration (FDA) to implement any new policies, they suggest.

The global market for biosimilars is expected to be worth US$19.4 billion by 2014, increasing at an average annual rate of 89.1% from 2009, according to a new report from Marketsandmarkets.

FOR IMMEDIATE RELEASE
September 28, 2009

Contact: Sara Crager, MD PhD, Yale University, and member, Universities Allied for Essential Medicines (UAEM)
Phone: (203) 444-4805 Email: [email protected]

Contact: Ethan Guillen, Director, Universities Allied for Essential Medicines (UAEM)
Phone: (775) 287-2553 Email: [email protected]**

CURRENT PROPOSALS IN HEALTHCARE REFORM BILLS WILL BLOCK MOST GENERIC BIOLOGICS

Student and consumer groups, Universities Allied for Essential Medicines (UAEM) and the American Medical Student Association (AMSA), supported by consumer groups Essential Action and Knowledge Ecology International, are today calling on Congress to create a real pathway for the production of generic biologics. Current proposals for generic biologics or “follow-on biologics” in Senate and House versions of healthcare reform legislation that purport to create such a pathway will actually block production of most generic biologics, which — if the current proposals are improved in critical ways — could save $71 billion or more in the first decade alone.

The organizations involved support healthcare reform now, but urge Congress to fix this serious challenge to future affordable access, both here and abroad, which could also create tremendous savings for the healthcare system.

To engage and educate consumers and patients from across the United States
in the fight for affordable medicines, UAEM and AMSA have launched a website, http://www.AffordableMedsNOW.org

The proposals, originating from legislation sponsored by Representative Anna Eshoo (H.R. 1548) in the House and counterparts in previous Congresses in the Senate, have two major flaws. First, the proposals will provide an excessive 12-year period of market exclusivity for generic biologics while other drugs receive a 5-year term, even though a 2009 PhRMA report notes similar development costs for biologics ($1.2 billion) and conventional drugs ($1.318 billion). The Federal Trade Commission recommended zero years market or data exclusivity for biologics, as follow-on biologics will cost more to bring to market for generic manufacturers than conventional generics, among other unique circumstances, leaving originator companies with 70%-90% of the market. The difference will further distort pharmaceutical innovation, which already fails to prioritize neglected diseases, and will give undue advantage to biologics over conventional drugs. Second, the proposals will allow abusive “evergreening” whereby pharmaceutical companies will be allowed additional 12-year periods of exclusivity for relatively inexpensive minor tweaks (for instance, making a twice-a-day shot once-a-day) made to the originator biologics. This could block price-lowering generic competition indefinitely.

Representative Henry Waxman and Senator Charles Schumer have already introduced alternative proposals (H.R. 1427/S. 726) that would better address both problems with current proposals by allowing 5 years of exclusivity and by blocking abusive evergreening. The most troubling aspects of the current biogenerics proposals in the healthcare bills should be corrected by adopting the relevant parts of the Waxman-Schumer bills.

Unlike small molecule medicines like Tylenol and Prilosec, biologics are complex macromolecules derived from living organisms and face higher barriers to generic production than other drugs. Biologics are the fastest growing segment of the drug market, are predicted to soon be 50% of new drug approvals, and include, among other things, most vaccines and treatments for cancer, multiple sclerosis, and rheumatoid arthritis. The pharmaceutical industry charges 22 times more for biologics than other drugs, and already, the top six biologics make up over 40% of the Medicare Part B spending.

In the coming weeks, UAEM, AMSA, and supporters will be working to organize students and others to let Congress know that patients, both here and in developing countries, need REAL generic biologics legislation now.
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Statements from Experts and Participating Organizations

Rebecca Mitchell, second- year medical student at University of California– San Francisco School of Medicine and Access to Medicines Campaign Director for the American Medical Student Association (AMSA), [email protected]

“As future physicians, we call upon Congress to ensure that life-saving generic biologic drugs are made affordable and accessible to our patients. Language in current health reform legislation creates biologic drug monopolies, which discourage innovation and raise costs for our health system.”

James Love, Director, Knowledge Ecology International, [email protected]

“Congress should not give the drug companies a poorly conceived generic pathway that will rarely be used. There are all sorts of issues in the pathway legislation, including not only the term of the monopoly, but also the standards for generic entry, and the opportunities for evergreening protection. The industry is spending millions to influence Congress, so that consumers will spend billions more on drugs. Congress needs to focus more on consumers, and give voters better reasons to choose them.”

Anthony So, MD, MPA, Member UAEM Advisory Board, Professor of the Practice of Public Policy Studies at Duke University’s Terry Sanford Institute of Public Policy, and Director, Program on Global Health and Technology

“These proposals extending monopoly protection on biologics grimly remind us of the decade-long struggle to lower AIDS drug prices. To go down this road would be to condemn us to repeat this history for biologic treatments, placing at risk the millions around the world who may need timely access to affordable, life-saving medicines in the years to come.”

Sarah Rimmington, Attorney, Essential Action’s Access to Medicines Project, Mobile (202) 422-2687

“I applaud the AMSA and UAEM students — the doctors, medical researchers, lawyers and other professionals of tomorrow — for taking the initiative to fight for real biogenerics legislation. The proposals currently being considered by Congress make a mockery of their purpose, to create an approval process for safe, affordable generic biologic drugs. Current proposals offer only the illusion of price-lowering generic competition for critical biotech drugs like Roche-Genentech’s up to $72,000 per year cancer treatment Herceptin. By making relatively cheap and easy tweaks to old biologic drugs near the end of the extra monopoly period, Big Pharma will often be able to obtain indefinite monopolies, at best keeping affordable biogenerics from pharmacy shelves several decades after their patents expire. These fake biogenerics proposals make no sense given the inseparable twin objectives of health care reform, cost containment and expanding coverage to all Americans.”

Sara Crager*, MD/PhD Candidate, Yale University, and member of Universities Allied for Essential Medicines (UAEM) Mobile (203) 444-4805

“As a PhD student and future biomedical researcher, I want the fruits of my research to be available as widely as possible as soon as possible. It is vital to foster innovation incentives to ensure that new treatments continue to be developed, but even the most efficacious new treatments are of no value if they are too costly to actually be available to the patients who need them. It is unjustifiable that Congress would allow health care reform to prioritize pharmaceutical company profits at the expense of patients. Moreover, despite what its proponents claim they are advocating, this bill will actually have the effect of deterring the development of truly innovative new treatments. Providing an additional 12 years of monopolybprotection for minor modifications to existent drugs will incentivize low-risk research agendas and result in an onslaught of ‘me-too’ drugs, slowing the discovery of the lifesaving drugs of the future.”

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About the Organizations

About Universities Allied for Essential Medicines

Universities Allied for Essential Medicines (UAEM) is a coalition of students at over 50 top research institutions across the United States, Canada, the United Kingdom, and Germany. UAEM’s mission is to ensure that people in developing countries have access to medicines developed in universities and that university medical research addresses the needs of the majority of the world’s population. As an organization which values innovation, we work to empower students to find new ways to improve access to health throughout the world. www.essentialmedicine.org.

About the American Medical Student Association

The American Medical Student Association (AMSA), with more than a half-century history of medical student activism, is the oldest and largest independent association of physicians-in-training in the United States. Founded in 1950, AMSA is a student-governed, non-profit organization committed to representing the concerns of physicians-in-training. With more than 62,000 members, including medical and premedical students, residents and practicing physicians, AMSA is committed to improving medical training as well as advancing the profession of medicine. To learn more about AMSA, our strategic priorities, or joining the organization, please visit us online at http://www.amsa.org/.

About Essential Action

Essential Action is a non-partisan, non-industry funded public health and corporate accountability group based in Washington, DC. Our Access to Medicines Project staff has worked on U.S. and global access to medicines issues for more than a decade, focusing on patent and related barriers to generic competition. www.essentialaction.org/access/

About Knowledge Ecology International

Knowledge Ecology International (KEI) is a not for profit, non-governmental organization that searches for better outcomes, including new solutions, to the management of knowledge resources. KEI is focused on social justice, particularly for the most vulnerable populations, including low-income persons and marginalized groups. KEI is particularly drawn to areas where current business models and practices by businesses, governments or other actors fail to address social needs, and where there are opportunities for sustainable improvements. KEI is an international organization with an international board and staff and maintains offices in Washington, D.C. and Geneva.
www.keionline.org.

Comunicación Positiva, a Colombian NGO that develops communication strategies for civic engagement and human rights, has produced a series of documentary audio programs and a video short covering the evolution of the HIV/AIDS compulsory license & access to medicines campaign in Colombia, 2008-2009. The Spanish-language series is entitled “For the right to health – no to patents!” (“Por el derecho a la salud – no a las patentes!”), and features interviews with about thirty activists, analysts and people living with HIV/AIDS.

Check out the video introduction (in spanish) on Youtube here.

To download a zip file (higher-resolution version also in spanish), click here.

To listen to the audio series (in spanish), visit this site.

The audio series (in spanish) is also available on CD from Comunicación Positiva. Contact: David Morales; [email protected]

Healthcare Reform Offers Only the Illusion of Generic Competition for Biotech Drugs: Patient Access To Expensive New Medicines at Stake

U.S. Congress is considering proposals to establish a process for regulatory approval of generic versions of biotech drugs (“biologics”). The Food and Drug Administration (FDA) approval process available for conventional pharmaceuticals does not apply to biologics, which are drugs engineered from human or animal cells using biotechnology. New and different procedures are required to demonstrate the safety and efficacy of comparable and interchangeable biologic pharmaceuticals (called “biosimilars” or “biogenerics”).

Proposals passed by the Senate and House health committees as part of healthcare reform in July 2009, however, will establish prolonged delays before permitting price-lowering generic competition. Even worse, they will facilitate brand-name companies’ ability to renew their monopolies, potentially keeping generic firms out of the market for biologics altogether and creating only the illusion of generic competition. Either result will torpedo the objective of healthcare cost containment so crucial to current reform efforts, and severely limit patient access to these important and exceptionally high-priced medicines for conditions like cancer, arthritis and diabetes.

The bottom line is this: Under these proposals, Medicare and other federal programs will find their budgets increasingly strained by growing biologic drug costs. Employers will continue to struggle to provide affordable health insurance to their employees. Americans with insurance will find it even more difficult to pay for their already sky-high prescription drug co-payments. And the uninsured may have to go without crucial lifesaving biologics.

For more information, download the .pdf version of the briefing note here: BiologicsBriefingNote28_Sept_09.pdf

Download a .rtf version of the briefing note here: BiologicsBriefingNote28_Sept_09.rtf

For more details about one of the most pressing issues in these proposals, the creation of almost indefinite monopolies through the evergreening of the data exclusivity monopoly, please see the fact sheet available here.

Bogotá, Colombia – Wednesday, September 16, 2009 –

Today, NGOs, attorneys and activists filed suit in Colombian court to compel the government to authorize price-lowering generic competition with Abbott Laboratories’ costly HIV/AIDS treatment Kaletra (lopinavir+ritonavir, LPV/r).

The “acción popular” demands an open compulsory license allowing any producer that can demonstrate drug safety and efficacy and good manufacturing practices to use patented technology to bring generic LPV/r to market.

Chicago-based Abbott enjoys a LPV/r monopoly in Colombia, where Kaletra, a key second-line HIV/AIDS medicine, ranks consistently among the health system’s most expensive annual medicine purchases and routinely sells for well over $3,000 per person per year. Global competitive prices have dropped under $500. Earlier this year, in response to Colombian NGOS administrative request for a compulsory license, the Colombian government imposed price ceilings on the drug – approximately $1,000 for public sector sales and $1,600 for the private sector. But recent reports suggest Abbott has violated the price order in its transactions with at least some purchasers. The National Commission on Medicine Prices is investigating.

The eighty-page acción popular cites state failures to provide for Constitutional and collective rights to health. It names the health ministry, patent office, drug regulatory authority and Abbott Laboratories as defendants. Plaintiffs include Fundación IFARMA, Fundación Misión Salud, RECOLVIH (Colombian network of people living with HIV/AIDS), and attorneys Luz Marina Umbasía (in her personal capacity), Giomar Angélica Aguilar and Germán Rincón Perfetti.

We will occasionaly issue updates on the suit’s progress and also hope provide more information soon. With questions, English speakers can contact Peter Maybarduk at Essential Action ([email protected]) or Francisco Rossi of the Colombian Foundation IFARMA, a plaintiff in the suit ([email protected]).

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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El Tiempo

Abbott está de nuevo en la mira del Gobierno por el precio de la medicina contra el sida Hace dos semanas, comenzó a verificar si el único vendedor de Kaletra en el país, y los compradores del producto están cumpliendo con el precio fijado oficialmente el pasado 28 de abril.

Ese día, la Comisión Nacional de Precios de Medicamentos (Cnpm) determinó que a partir de ese momento cada frasco del producto mencionado tendría un precio de referencia o máximo de 88,94 dólares en el canal institucional y de 132,60 dólares, en el canal comercial, límites que se sitúan muy por debajo de los valores a los que se estaba negociando el Kaletra.

Sin embargo, el rumor en el sector de la salud es que Abbott, multinacional estadounidense que lo produce, hizo caso omiso de la circular 002 de la Cnpm expedida a finales de abril y siguió cobrando el precio viejo.

“Oficialmente no sabemos que el Kaletra se esté cobrando por encima del precio de referencia”, dijo la secretaria de la Cnpm, Carolina Lorduy, quien precisó que “esto ha sido de oídas”.

No obstante, Lorduy confirmó a este diario que el organismo, a cuya cabeza se encuentran los ministros de Comercio y de la Protección Social y un delegado del Presidente de la República, está verificando el cumplimiento del precio de referencia.

Las Empresas Promotoras de Salud (EPS) y las Entidades Territoriales de Salud, que hacen parte del canal institucional, son grandes compradores de Kaletra, cuyo nombre genérico es Lopinavir y Ritonavir, medicina que está en el Plan Obligatorio de Salud (POS) y, por lo tanto, se paga con recursos públicos.

El presidente de la Nueva EPS, que nació de la desaparecida EPS del Seguro Social y la participación de seis cajas de compensación familiar, Héctor José Cadena, comentó que cuando el Seguro Social era público compraba el medicamento a un precio preferencial, pero ahora Abbott se lo cobra al mismo precio que a otras EPS.

El directivo, cuya EPS atiende a 3.700 pacientes con VIH-sida y a 200 de los cuales les administra Kaletra, se abstuvo de revelar el valor al cual está comprando la medicina “porque existe un acuerdo de confidencialidad con el laboratorio”.

Sin embargo, una fuente de entero crédito de la Nueva EPS aseguró que Abbott lo está cobrando muy por encima del precio de referencia. “No ha habido ningún cambio de precio después del 28 de abril”, señaló la fuente.

El tratamiento anual por paciente es de 12 frascos de Kaletra que, de acuerdo con el precio de referencia fijado por la Cnpm, es de 1.067,28 dólares en el canal institucional y de 1.591,20 dólares, en el comercial (grandes superficies, mayoristas, droguerías, etc.).

Una orden de pedido de una caja de compensación familiar del 19 de junio por 10 frascos de Kaletra reporta un valor de 7’158.000 pesos, para un precio unitario de 715.800 pesos, que a la tasa de cambio de ese día (2.074,72 pesos por dólar) arroja 345 dólares.

Si se aplica la tasa del 23 de junio, día de entrega, (2.108,20 pesos), el precio es de 339,53 dólares. Los dos valores superan ampliamente el precio de referencia fijado por la Cnpm.

Abbott Colombia remitió a este diario a un responsable de la casa matriz en Estados Unidos para tratar con él algunas preguntas sobre el tema, las cuales le fueron enviadas, vía e-mail, el 24 de agosto, pero al cierre de esta nota no habían tenido respuesta.

Carolina Lorduy reiteró que, respecto al Kaletra, están mirando toda la cadena a ver qué es lo que ha sucedido.

En caso de incumplimiento del precio de referencia, el caso será remitido a la Superintendencia de Industria y Comercio (SIC), que aplicaría sanciones por el no acatamiento de lo dispuesto por la Cnpm.

Este domingo, el ministro de la Protección Social, Diego Palacio, les envió una carta a las EPS y Entidades Territoriales de Salud en la que, a propósito del tema de precios del Kaletra, advierte que el Estado “evitará cualquier abuso que personas o empresas hagan de su posición dominante en el mercado”, no sin antes recordarles que el medicamento no tiene competidor en el mercado y que su titular e importador es Laboratorios Abbott.

Así mismo, Palacio les indica que en el momento de comprar el producto mencionado “tengan en cuenta el precio de referencia establecido por la Cnpm, el cual es de obligatorio acatamiento”. No se pudo determinar si este recorderis del “obligatorio acatamiento” también fue enviado a la multinacional farmacéutica.

De todas maneras, el Ministro le expresa su apoyo a la Cnpm y le pide continuar con las labores de verificación de los precios que se cobran en el mercado.

Niegan recurso a la farmacéutica
Hace más de un año, un grupo de ONG le pidió al Gobierno ‘quebrar’ la patente del Kaletra y permitir la competencia de productos genéricos con el fin de comprarlo precios más bajos. La petición fue negada.

Posteriormente, la Cnpm estableció que el medicamento se vendía en el país en el canal institucional a 3.443 dólares el tratamiento anual y a 3.296 dólares en el canal comercial y el 28 de abril le fijó el precio de referencia mencionado.

Laboratorios Abbott interpuso un recurso, que la Cnpm declaró improcedente el pasado 10 de agosto. Ocho días después, la farmacéutica pidió la revocatoria directa de la circular 002; la Cnpm aún no se ha pronunciado.

August 31
JORGE CORREA C.
REDACCIÓN DE ECONOMÍA Y NEGOCIOS