Health GAP and Allies Release Analysis on Uganda HIV Criminalization Case

Analysis: 10 Grave Flaws, Myths & Outright Lies That Plagued Rosemary Namubiru’s Court Case

Released by: International Community of Women Living with HIV Eastern Africa (ICWEA) • Health GAP •  Uganda Network on Law, Ethics and HIV (UGANET) • Uganda Health Sciences Press Association (UHSPA)

Rosemary Namubiru, a 64 year old nurse at Victoria Medical Center, was tried, convicted and sentenced to three years in prison for criminal negligence‘ arising from an incident where she was pricked by a needle while administering medicine to a 2 year old patient, and may have accidentally reused that needle on the child after bandaging her pricked finger. The judgment was severely flawed and will be appealed by Namubiru.

Namubiru is HIV positive. The child quickly received post exposure prophylaxis (PEP), and subsequent HIV tests have indicated the child did not contract HIV as a result of the incident. This was a workplace error that warranted appropriate action by her employer and the relevant professional council. How did Uganda reach a point where such a flawed judgment and harsh criminal sentence could be handed down from court? 

Because of Namubiru's HIV status, shameful sensationalization by the media, and outright lies by the prosecution, police, and the media, Rosemary never got a fair hearing in Court.

Download the analysis: What went wrong? 10 Grave Flaws, Myths & Outright Lies That Plagued Rosemary Namubiru’s Court Case

 


Civil Society Responds to GFATM E.D.'s proposal for Tiered Pricing

Mark Dybul, Executive Director of the Global Fund, has been circulating a proposal among select partner organizations (UNITAID, UNDP, UNICEF, GAVI, and the World Bank) proposing a Blue Ribbon Task Force to address pricing and access barriers in middle-income countries primarily through a recalibrated tiered-pricing framework.  Previous drafts have received major civil society and activist critiques at ICASA, at board meetings of the Global Fund and UNITAID, and in analyses of leaked documents.  Collectively, our voices have not been strong enough objecting to a proposal that would ultimately vest control over medicines prices in industry, which has been fighting for a global platform for this stale and discredited idea for over a decade.  Affected governments, people living with diseases, and civil society more generally have been excluded from the process.  Many more promising ideas, including use of intellectual property flexibilities allowed under international law, are not yet included in the latest draft of the Dybul proposal.

Over 50 people from various networks have contributed to the drafting of this letter demanding that the initiative be dropped, which now need broad distribution and sign-ons.  References to additional information are provided below below my signature.

Claire Cassedy from KEI  has kindly agreed to support the collection of civil society endorsement/signatures, so please contact her (cc copying Judit Rius of MSF) if your organization would like to sign into this letter that we can send to Mark Dybul (and Heads of other agencies cosponsoring this initiative) the week of May 12 and share with Member States and civil society attending the World Health Assembly (WHA) in Geneva from  May 19-24

Next Steps: 

- Contact Claire (cc copying Judi) before Friday May 9  if your organization wants to sign into this letter

claire.cassedy@keionline.org  

Judit.Rius@newyork.msf.org 

 

For all: please share the letter with relevant networks of civil society & lists so that other organizations can also sign in.  
A summary of what is publically available & can already be shared:

- March concept note and Brook Baker analysis: http://infojustice.org/archives/32565
- February concept note & Thiru analysis : http://keionline.org/node/1979
- Letter from activists to Mark Dybul post-Icasa meeting: https://groups.yahoo.com/neo/groups/internationaltreatmentpreparedness/conversations/topics/24403     
- Suerie Moon blog: http://blogs.plos.org/speakingofmedicine/2013/12/01/is-the-global-fund-heading-backwards-on-access-to-medicines/
- MSF initial reaction: http://www.msf.org/article/global-fund-proposed-shake-drug-pricing-framework-risks-middle-income-countries-paying-more
- IP Watch article on the initiative: http://www.ip-watch.org/2014/04/07/global-fund-and-tiered-medicines-pricing-under-debate/


Analysis of the ViiV/Medicines Patent Pool Dolutegravir Patent Licenses

by Brook Baker, Health GAP Senior Policy Analyst

Originally posted on InfoJustice.org

This paper provides a detailed analysis of the effective geographical scope of the recently announced adult and pediatric between the Medicines Patent Pool and ViiV Healthcare covering dolutegravir. an important integrase inhibitor.  In addition to providing a comprehensive analysis of the effective geographical scope of the licenses, taking into account both the formally licensed territory and territories where ViiV patent rights would not be violated by sales of dolutegravir, the paper also analyses other key aspects of the licensing agreement.

Although the effective geographical scope is broad, it is not as inclusive of middle-income countries as desired (coverage 93.4% for adults, 99.3% for children).  Excluded countries and their supporters should demand inclusion, but even in the absence of voluntary action by ViiV, countries can use oppositions to pending and granted patents (where available) or compulsory licensing to gain access to this medicine and its combination with other ARVs.

Read the full paper.


US's "new" proposed TPP IP Chapter still requires patents on medicinal forms with "distinguishing features"

by, Prof. Brook K. Baker, Health GAP

Feb. 7, 2014

IP, health and trade activists expressed outrage in early 2011 when the proposed US IP Chapter for the Trans-Pacific Partnership Agreement was first leaked.  Particularly concerning was the language of section 8.1, addressing standards of patentability, that that proposed a substantial weakening of patentability criteria, including required patenting of new forms and new uses of existing medicines:  "[T]he Parties confirm that:  patents shall be available for any new forms, uses, or methods of using a known product; and a new form, use, or method of using a known product may satisfy the criteria for patentability, even if such invention does not result in the enhancement of the know efficacy of that product."

Other TPP negotiators were reported to be uniformly opposed to the U.S. proposal and the unconfirmed reports 2012-13 were that the U.S. had dropped its demand that new forms be patented.

The Wikileak disclosures of more recent IP chapter positions has revealed that the US has not so much dropped the demand that patents be granted for new forms, but rather has hidden the same demand in new language:  “The Parties confirm that: (a) patents shall be available for any new uses or methods of using a known product and (b) a Party may not deny a patent solely on the basis that the product did not result in enhanced efficacy of the known product when the applicant has set forth distinguishing features establishing that the invention is new, involves an inventive step, and is capable of industrial application.”

The identical language in both US proposals is that TPP members would not be permitted to assess enhanced efficacy in determining whether an alleged invention is patentable.  This provision is a direct challenge to section 3(d) of India's Amended Patents Act, which was famously used by the Supreme Court of India to deny Novartis's application for a patent on Glivec.  Section 3(d) has been used in other opposition proceedings and decisions of the Indian Patents Office to deny secondary patents on minor variations to existing medicines where the variations do not evidence significantly enhanced efficacy in treating humans (not just in terms of physical properties like stability).  Other countries are beginning to mimic the Indian provision, e.g., the Philippines, and comparable reforms are being proposed in important pharmemerging markets including Brazil and South Africa.

But in other respects, the new section 8(1)'s language concerning products with "distinguishing features" is linguistically equivalent to the earlier version concerning "new forms."  Something new is something that is distinguishable from what existed before.  Thus, many of the unpatentable new forms specified in India's section 3(d), e.g., "salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance" would have "distinguishing features" under the US proposal and thus be patentable.  

IP maximalist positions in US TPP proposals never go away.  The only patent demand that seems to firmly have been dropped is the US position outlawing pre-grant opposition procedures.  The US is also reported to be proposing a transition period for Vietnam, Peru, Mexico, and Malaysia with respect to some of its patent and data monopoly demands, but that freedom will be temporary and partial.

Granting patents on new forms of existing medicines – or under the new language on forms with distinguishing features – is the essence of low/weak patent standards that results in evergreening – successive and recursive patenting of a medicine to extend the period of monopoly protection.  TPP trading partners should continue to reject this US proposal or their access to affordable generics will be seriously constrained.


New Health GAP Report: “The Politics of Transition & Economics of HIV/AIDS & PEPFAR in South Africa”

Health GAP and partners have released 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.


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