The Latest News from Health GAP
Health GAP Statement on BMS Patent Pool Licenses for ATV Access
Medicines Patent Pool agreement with Bristol-Myers Squibb expands access to critical second-line AIDS medicine, even while BMS excludes some middle-income countries. More companies should join the Pool and offer expanded geographic coverage.
Health GAP applauds the announcement of a new licensing agreement negotiated by the Medicines Patent Pool with Bristol-Myers Squibb (BMS) for a key second-line protease inhibitor, atazanavir (ATV). Although the official territory is comprised of 110 low- and middle-income countries, a key clause allows generic licensees to sell without obstacles in another 34 countries where no ATV patent is in force. In addition, generic licensees will be able to supply countries that issue compulsory licenses. The new agreement effectively extends coverage to many more people with HIV than the prior 49-country deal BMS had previously confidentially negotiated with three generic licensees.
The scope of the license covers nearly 90% of people living with HIV in low- and middle-income countries, but the remaining 10%, who live in middle-income countries, are still not covered. Some of the excluded 10% are left without coverage because they fall under a separate bilateral agreement made between BMS and the Brazilian Government. People living with HIV need 100% coverage and thus urge the MPP, BMS, and other MPP licensors like Gilead to expand geographic coverage.
“Companies with existing MPP agreements should commit to expanding coverage,” said Professor Brook Baker, Senior Policy Analyst for Health GAP. “But it is also essential that other companies with critical new medications enter into open-access licenses with the Pool and ensure coverage for all low- and middle-income countries. This is particularly urgent for ViiV, whose majority shareholder, GlaxoSmithKline is demanding extremely narrow coverage for dolutegravir. Abbvie should open access to lopinavir and ritonavir separately so that ritonavir can be used as a booster with ATV and other protease inhibitors. Also, Merck and Johnson & Johnson, the last two hold-outs, must speedily license their HIV drugs,” said Baker.
“Achieving an AIDS-Free Generation requires expanding access to better ARV treatment regimens, and that depends on a critical mass of companies joining the Medicine Patent Pool with overlapping territories. There is urgency with respect to existing WHO-recommended regimens, but we also demand rapid access to critical new, improved ARVs like dolutegravir and tenofovir pro-drug," said Paul Davis of Health GAP.
“People with HIV in low- and middle-income countries have a right to expedited access to the latest treatments that are more effective, longer lasting, and have fewer side effects. Many of the ground-breaking new medications will be much, much cheaper to produce because they contain simpler molecular structures and lower amounts of active ingredients,” said Health GAP’s Maureen Milanga in Nairobi. “We need GSK and Merck to speed up talks with the Patent Pool for game-changing new products like TAF and DTG.”
“Governments that aren't included in MPP licenses should issue compulsory licenses and use all other public health flexibilities that are part of the WTO’s TRIPS Agreement,” stated Health GAP’s Asia Russell. “Such options will have a much more positive impact on affordability and access than industry-oriented proposals such as tiered-pricing initiatives.”
AIDS Activists Condemn Massive New Drug Company Offensive Against
South Africa’s Patent Reform and Access to Affordable Medicines
In a deadly reprise of their 1998 lawsuit against the Mandela government for attempting to increase access to affordable generic medicines, the multinational drug industry is once again mounting a major disinformation campaign against efforts by South Africa to amend its patent laws. AIDS activists today condemned the secret effort, revealed by the Mail & Guardian and Reuters and decried by South Africa’s Minister of Health as “genocide.”(See: http://mg.co.za/article/2014-01-16-motsoaledi-big-pharmas-satanic-plot-is-genocideand http://www.reuters.com/article/2014/01/17/safrica-pharma-idUSL5N0KQ35720140117)
Secret consulting agreements and email correspondence leaked to journalists show a major conspiracy, paid for in large part by PhRMA, the U.S. pharmaceutical industry association, to bypass the courts and instead to use lies and distortions domestically in South Africa and abroad to stop lawful IP reform in its tracks.
International intellectual property law, including the WTO TRIPS Agreement, allows governments to modify their laws to incorporate certain flexibilities that increase access to affordable medicine. “South Africa has an archaic patent system that grants patents without examining their true merits, meaning that South Africa grants a larger number and a higher percentage of drug patents than any country in the world,” said Professor Brook Baker of Health GAP.
Following a push by people living with AIDS and civil society groups including the Treatment Action Campaign, Doctors Without Borders, and Section 27, the South African government released a draft IP policy in September that would tighten up patent standards and prevent poor quality patents—as had been recommended by UN and academic experts.
Multinational pharmaceutical companies, however, were not deterred by the legality and benefits to patients of the policies and have planed a massive disinformation campaign to threaten South Africa with withdrawal of capital investment and a loss of competitiveness. “Although empirical evidence shows virtually no connection between heightened IP protections in Africa and increased rates of foreign investment, PhRMA and its drug company allies are poised to argue otherwise – over and over again,” said Professor Baker.
As an example, a course of the patented medicine for drug-resistant Tuberculosis costs nearly $45,000 per year in South Africa while a generic version available in India costs just 3% of this total.
“American drug companies are plotting to keep affordable drugs out of the hands of the vast majority of South Africans—for AIDS, tuberculosis, cancer—so they can make more profit off the wealthy few in the country who can pay,” said Paul Davis of Health GAP. “These companies tried to do the same and failed when they sued Nelson Mandela; with their plans exposed they will not succeed this time either.”
Big Pharma was shamed in front of the whole world 1998-2001 over its lawsuit against South Africa seeking to stop the country from enacting a law supporting affordable generic drugs, which it finally withdrew following a deluge of negative press in March of 2001. These same drug companies are now trying to use a similar, but more hidden dirty-tricks campaign, to defeat lawful IP reform in South Africa using false academics and lobby visits instead of lawyers with briefcases to do their dirty work. | More
Health GAP and partners releases a new report: “The Politics of Transition & Economics of HIV—AIDS & PEPFAR in South Africa”
which accompanies an article forthcoming in Journal of Acquired Immune Deficiency Syndromes.
The report looks at the PEPFAR "transition" in the country--moving from "directly supporting" over 1 million people on ARV treatment in South Africa in early 2011 to a near complete withdrawal from support for "direct services." The report tracks the impact of transition in both of the two main PEPFAR service models: patients in NGO/private clinics who needed to be moved to the public sector as well as those PEPFAR patients already in the public sector when PEPFAR-funded staff, infrastructure, and commodities were pulled out of public clinics.
The report finds that the political transition--toward increased South African ownership and innovative models of shared governance for U.S. funds--is yielding important benefits.
However, interviews across several months reveal that the transition moved far too quickly and was too often driven by contract end-dates than by the readiness of the public sector. Based on the only public study available, we estimate tens of thousands of people may have experienced care disruption because failed to track patients and ensure support for treatment continuity--though without patient tracking the exact size of the problem is not known. Meanwhile important human resources were lost to the AIDS response at a time when many more are needed.
The report recommends an urgent course correction for PEPFAR South Africa—tracing patients and health workers while considering a more measured approach in the country. Beyond South Africa the report recommends putting any further transitions on hold and clarifying PEPFAR’s commitment to support direct treatment support in low- and middle-income countries.
Read the full report online.
Attached is a copy of the JAIDS editorial. which is also online at: http://journals.lww.com/jaids/pages/articleviewer.aspx?year=9000&issue=00000&article=97993&type=abstract .