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Posted on Categories General News 268 Comments on Two mentally ill men stranded at Gulu hospital

Two mentally ill men stranded at Gulu hospital

By Alex Otto

Authorities at Gulu regional referral hospital mental health unit are stuck with two mentally ill persons who were referred back from Butabika mental health hospital where they reportedly spent 12 years and cannot now locate their families in northern region.

The men, James Owot aged about 60 and Okwonga Gulu(name given from hospital) aged about 40 have so far been at the Gulu mental health unit for months after they were referred back from Butabika hospital.

Tracing home

“Because of the disorder, they cannot identify their homes, so anyone who knows and can be able to trace information that can lead to the unity of these two people with their families should contact the hospital authorities, “ Paul Aluma, the Principal Psychiatric officer in charge of Gulu Regional Referral Hospital –Mental Health Unit said.

“Owot says he studied from Keyo primary school and their home is in Awer Lamogi Sub County in Amuru district.”

The other one, Gulu, dumb and tracing information about him is difficult. Hospital authorities suspect  that he is from Lira, but nothing much is really know about him.

Geoffrey Oloya, the Nwoya district focal person for mental health, requested residents of Lamogi in Amuru district and the community of Lango subregion to try and identify their relatives, friends and neighbors who once had a case of mental illness and were later taken to Butabika hospital.

Statistics

Aluma states that on a daily basis, the mental health unit registers eight new clients and the daily attendance is estimated at between 50 to 60 new patients who come to seek medication aid.

“Every day we admit two or four new patients both female and male and monthly records indicate that new cases range from 70 to 80, which totals to about 900 patients monthly,” he said.

Oloya asked family members of the mentally ill not to neglect them because their situation can still normalize with adequate care, treatment and consideration.

The duo were presented on Thurdays during the mental health day celebrations at Gulu regional referral hospital’s mental health unit with the theme “Investing in mental health”.

Source: New Vision

http://www.newvision.co.ug/news/19057-Two-mentally-ill-men-stranded-at-Gulu-hospital.html


Posted on Categories General News 51 Comments on WHO: “Member State” mechanism on compromised medical products Published in SUNS #7256 dated 9 November 2011

WHO: “Member State” mechanism on compromised medical products Published in SUNS #7256 dated 9 November 2011

TWN Info Service on Intellectual Property Issues (Nov11/03)
10 November 2011
Third World Network

WHO: “Member State” mechanism on compromised medical products
Published in SUNS #7256 dated 9 November 2011

Geneva, 8 Nov (Sangeeta Shashikant) — A new intergovernmental mechanism will be set up at the World Health Organisation (WHO) to deal with medical products of compromised quality, safety and efficacy.

As a compromise over continuing differences on WHO’s operations in dealing with these products, governments that met from 25-28 October 2011 agreed to establish a “Member State (MS) mechanism” with a broad mandate on the prevention and control of compromised medical products, that includes addressing access to affordable medical products, including the supply and use of generic medical products.

This agreement was achieved late night on the last day of the closed-door session of the open-ended working group (OEWG) on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products (SSFFC) that met in Geneva.

The outcomes of the OEWG are an agreed draft resolution, an annex containing the agreed goals, objectives and terms of reference of the MS mechanism and a report on the outcome of the OEWG. These documents will be considered by the Executive Board meeting in January 2012 before being transmitted to the 2012 World Health Assembly (WHA) for adoption.

The OEWG was established in 2010 to bridge the deep divisions among WHO Member States over the Organisation’s approach to compromised medical products, particularly its association with the International Medical Product Anti-Counterfeit Taskforce (IMPACT), an initiative linked with intellectual property enforcement. There were also divisions over the continued use of the term “Counterfeit” (defined in the WTO TRIPS Agreement as referring to a special category of trademark violations) to refer to poor quality, unsafe medicines. The first meeting of the OEWG took place in February 2011 (see SUNS #7103 dated 8 March 2011).

While these issues remain unresolved, the setting up of an intergovernmental mechanism by the OEWG to determine actions that should be taken to address the availability of quality, safe and efficacious medical products from a public health perspective suggests that WHO’s approach to compromised medical products and in this regard “business as usual” in WHO is simply unacceptable to Member States.

[While the establishment of a MS mechanism was agreed to by the OEWG, the Report of the OEWG notes that divergent views were expressed with regard to WHO’s involvement with IMPACT. It further notes that, “A way forward on this specific issue could emerge when the new mechanism is considered at the 65th session of the WHA”].

According to the final agreed outcome, the MS mechanism, open to all WHO members, will be for an initial period of three years, for “international collaboration among Member States, from a public health perspective, excluding trade and intellectual property considerations, regarding ‘SSFFC medical products'”.

[The language of “excluding trade and intellectual property considerations” is derived from the mandate of the OEWG. At the 2010 World Health Assembly, there were concerns that WHO was being drawn into IP enforcement initiatives and was using terminology such as “counterfeit” associated with IP as it dealt with compromised medical products. This led Member States to expressly exclude IP considerations from the mandate of the OEWG.]

The MS mechanism has a broad mandate to deal with the prevention and control of SSFFC medical products that includes to collaborate and contribute to WHO’s work that addresses access to affordable medical products, including the supply and use of generic medical products. The mandate to address “affordability” was particularly controversial, as some countries argued against its inclusion. The Africa Group submitted a proposal on the last day of the meeting that did not include issues related to access to medicines.

The MS mechanism is also mandated to facilitate consultation, cooperation and collaboration with relevant stakeholders but in a “transparent and coordinated manner”, and from a public health perspective. The terms of reference of the MS mechanism also clearly notes that, “Possible conflicts of interests shall be disclosed and managed in accordance with the polices and practice of WHO”.

The issue of definitions of SSFFC medical products that was unresolved by the OEWG will also be taken up by the MS mechanism.

The establishment of the MS mechanism follows intense discussions behind closed doors on mechanisms best suited to deal with the problem of compromised medical products.

An initial Chair’s draft text of 14 October circulated prior to the OEWG meeting proposed three separate mechanisms. It proposed the establishment of: (i) a subcommittee of the Expert Committee on Specification for Pharmaceutical Preparations to develop a revised definition of SSFFC medical products and to develop other guidance on the matter; (ii) a multi-stakeholder mechanism to address the issue of SSFFC from a policy and operational perspective and to promote formal and/or informal collaboration in a coordinated manner among various stakeholders involved in addressing the issue including providing assistance to MS; and (iii) a standing high level coordinating mechanism, comprised of relevant UN agencies and programmes and other inter-governmental international and regional organizations, in order to exchange experiences and inform each other about ongoing activities as well as coordinate the respective actions in the field of SSFFC.

The proposal contained in this text was unacceptable to many Member States during informal consultations held on the text on 17 and 19 October. Subsequent versions of the text were also not accepted. According to sources, objections were expressed by several Member States against the establishment of any form of multi-stakeholder mechanism or a coordination mechanism among Secretariats of international or regional organizations that bypasses Member States.

Civil society groups also objected to such mechanisms in a letter signed by more than 50 NGOs addressed to Ambassador Darlington Mwape from Zambia. The letter cautioned against such mechanisms and noted that, “WHO’s work on QSE (quality, safety and efficacy) must be driven by its Member States and not by other organizations or entities”.

It also expressed concern over “WHO’s cooperation with other organizations such as Interpol and the World Customs Organization particularly as these organizations are known to continue using ‘counterfeit’ to refer to medical products of compromised QSE and promote IP enforcement”.

It also stressed that “any mechanism that is developed should be intergovernmental in nature, open to all Member States with decision-making powers remaining with WHO Member States”. The letter also urged WHO Member States to discontinue using the term “counterfeit” to refer to medical products of compromised QSE, and to disengage WHO from IMPACT, as the latter lacks credibility and legitimacy.

The “Agreed Elements of the MS mechanism” contained in an Annex to the draft resolution agreed at the OEWG are as follows:

General goal: “In order to protect public health and promote access to affordable, safe, efficacious and quality medical products, promote, through effective collaboration among Member States and WHO, the prevention and control of SSFFC medical products and associated activities”.

Objectives:

“1) To identify major needs and challenges and make policy recommendations, and develop tools in the area of prevention, detection methodologies and control of SSFFC medical products in order to strengthen national and regional capacities.

“2) To strengthen national and regional capacities in order to ensure the integrity of the supply chain.

“3) To exchange experiences, lessons learnt, best practices, and information on ongoing activities at national, regional and global levels.

“4) To identify actions, activities and behaviour that result in SSFFC medical products and make recommendations, including for improving the quality, safety and efficacy of medical products.

“5) To strengthen regulatory capacity and quality control laboratories at national and regional levels, in particular for developing countries and LDCs.

“6) To collaborate with and contribute to the work of other areas of WHO that address access to quality, safe, efficacious and affordable medical products, including, but not limited to the supply and use of generic medical products, which should complement measures for the prevention and control of SSFFC.

“7) To facilitate consultation, cooperation and collaboration with relevant stakeholders in a transparent and coordinated manner, including regional and other global efforts from a public health perspective.

“8) To promote cooperation and collaboration on surveillance and monitoring of SSFFC medical products.

“9) To further develop definitions of SSFFC medical products that focus on the protection of public health.”

Structure: “1) The Member State mechanism will be open to all Member States. The Member State mechanism should include expertise in national health and medical products regulatory matters. 2) The Member State mechanism may establish subsidiary working groups from among its members to consider and make recommendations on specific issues. 3) Regional groups will provide input into the Member State mechanism as appropriate. 4) The mechanism shall make use of existing WHO structures.”

Meetings: “1) The Member State mechanism should meet not less than once a year and in additional sessions as needed. 2) The default venue for the Member State mechanism, and its subsidiary working groups, will be Geneva. Meetings may, however, be held from time to time outside of Geneva taking into account regional distribution, overall cost and cost-sharing, and relevance to the agenda”.

Relations with other stakeholders and experts: “1) As needed the Member State mechanism should seek expert advice on specific topics, following standard WHO procedures for expert groups. 2) As needed the Member State mechanism will invite other stakeholders to collaborate and consult with the group on specific topics.”

Reporting and review: “1) The functioning of the mechanism shall be reviewed by the WHA after three years of its operation. 2) Report to the WHA through the Executive Board on progress and any recommendations annually as a substantive item for the first 3 years and every 2 years thereafter.”

Transparency and conflict of interest: “1) The Member State mechanism, including all invited experts, should operate in a fully inclusive and transparent manner. 2) Possible conflicts of interest shall be disclosed and managed in accordance with the policies and practice of WHO.”

The key elements of the draft resolution include the Preambular paragraphs:

— reaffirms “the fundamental role of WHO in ensuring the availability of safe, quality and efficacious medical products”;

— recognizes “the need to promote access to affordable, safe, efficacious and quality medicines including through the full implementation of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property”;

— recognizes “the importance of ensuring that combating SSFFC medical products does not result in hindering the availability of legitimate generic medicines”;

— acknowledges “the need for improving access to affordable, quality, safe and efficacious medicines as an important element in the effort to prevent and control medicines with compromised quality, safety and efficacy and in the decrease of SSFFC medical products”;

— takes “note of resolution 20/6 of the United Nations Commission on Crime Prevention and Criminal Justice entitled ‘Countering fraudulent medicines, in particular their trafficking'”;

— expresses “concern regarding the lack of sufficient financing of WHO’s work in the area of quality, safety and efficacy of medicines”;

— recognises “the need to enhance support to national and regional regulatory authorities to promote the availability of quality, safe and efficacious medical products”.

In addition to setting up the MS mechanism, the operative paragraphs of the draft resolution reaffirm the fundamental role of WHO in ensuring the safety, quality and efficacy of medical products, in promoting access to affordable, quality, safe and efficacious medicines, and in supporting national drug regulatory authorities in this area, in particular in developing countries and least developed countries.

It reiterates that WHO should continue to focus on and intensify its measures to make medical products more affordable, strengthening national regulatory authorities and health systems which includes national medicine policies, health risk management systems, sustainable financing, human resource development and reliable procurement and supply systems; and to enhance and support work on pre-qualification and promotion of generics, and efforts in rational selection and use of medical products.

In each of these areas, WHO’s function should be: information sharing and awareness creation; norms and standards and technical assistance to countries on country situation assessment; national policy development; and capacity building, supporting product development and domestic production.

It further reiterates that WHO should increase its efforts to support Member States in strengthening national and regional regulatory infrastructure and capacity. It is decided that the MS mechanism will be reviewed after three years of operation, and urges Member States to: (1) participate and collaborate with the Member State mechanism; and (2) provide sufficient financial resources to strengthen the work of WHO in this area.

The WHO Director-General is requested to support the MS mechanism and to assist Member States in building capacity to prevent and control “SSFFC medical products”.

source: http://www.twnside.org.sg/title2/intellectual_property/info.service/2011/ipr.info.111103.htm
Posted on Categories General News 352 Comments on Consensus Remains Elusive as WTO Ministerial Looms

Consensus Remains Elusive as WTO Ministerial Looms

WTO members are struggling to find consensus on a host of topics as the 15-17 December ministerial meeting draws nearer. Despite a plethora of proposals on possible non-Doha work, ranging from least developed country (LDC) accessions through to humanitarian food aid, deep-seated divisions between members continue to stymie progress on even a low-ambition outcome for the gathering, sources say.

Amid growing uncertainty over whether trade ministers will be able to reach agreement on a joint ministerial declaration, with one official calling it a “more and more remote possibility,” some trade officials told Bridges that the conference might now aim merely to produce a ‘chair’s statement’, describing some of the issues that ministers had discussed.

Although less authoritative than a collective communiqué by members, the tactic could allow the global trade body to skirt some of the disagreements that have emerged in the wake of countries’ recognition that the Doha Round of trade talks remains at an impasse.

Another option being considered was a “chair’s summary,” one official told Bridges; like the statement, a summary would be taken on the General Council chair’s responsibility. The last WTO Ministerial Conference, held in Geneva in 2009, also produced a chair’s summary at the end of the event.

A chair’s statement, however, could also have more binding elements in terms of “soft decisions,” the official explained.

However, a chair’s statement “might give the impression that ministers didn’t lend their full weight to the process,” one Geneva delegate acknowledged.

Plan for Doha remains unclear

While the ministerial meeting is intended to address both the WTO’s regular work programme and the future of the Doha talks, ongoing controversy over the latter question reportedly led to tense discussions between major economic players at the G-20 summit in Cannes last week (see related article in this issue).

The US, India, China and Brazil haggled at length over the precise wording of the final communiqué for the Cannes event, according to sources familiar with the discussions.

In Geneva, the same countries have also been locked in discussions over draft wording to describe what should be done about Doha, as part of a group of around 15 ambassadors that have been meeting on a weekly basis for some months now. While the group had reportedly reached broad agreement on language recently, sources said that this had encountered difficulties over new proposals to agree on a work programme for 2012.

“We should put [Doha] in the deep freeze for two years” said one official, who argued that negotiators could then return to the draft texts that were tabled earlier this year once the political climate had improved (see Bridges Weekly, 27 April 2011).

Others cautioned that, unless negotiators keep talking, the progress achieved so far could be lost completely. “2012 risks becoming a lost year” said one official, who argued in favour of a work programme of discussions on trade issues.

The language of the G-20 communiqué did provide some guidance, one developing country source noted; however, “how to operationalise” this guidance is where the tough part comes in.

WTO Director-General Pascal Lamy is continuing to hold consultations with members on how to proceed with the Doha process, the same official added.

Lack of consensus on non-Doha proposals

With little consensus on the non-Doha proposals that have been tabled to date, the chair of the General Council has told delegates they should continue to seek agreement on issues for the ministerial – despite an unofficial deadline of 2 November by which members were supposed to have achieved consensus on their proposals and then tabled those items for the meeting’s agenda.

Individual committees can continue discussing issues under their remits in the weeks ahead of the next General Council meeting, scheduled for 1-2 December, delegates said.

The African Group has also submitted a set of proposals, including for a ‘standstill provision’ that would freeze domestic support for cotton at historically-low current levels. In addition, net-food importing developing countries have argued in favour of a work programme on food price volatility. The African Group has also proposed providing greater flexibility to least-developed and developing countries that wish to join the WTO.

The G-90, which includes the African Group, the ACP (African, Caribbean, and Pacific) Group, and least developed countries, is also bringing a proposal on mainstreaming development within the scope of the Committee on Trade and Development.

A cross-regional group of countries has also tabled a proposal to exempt humanitarian food purchases from agricultural export restrictions, based on language originally agreed by the G-20 (see Bridges Weekly, 2 November 2011).

Consultations on these proposals are expected to continue in the weeks ahead. The General Council Chair, Ambassador Yonov Frederick Agah of Nigeria, is also holding consultations regarding subjects for “soft decisions,” or areas where ministers might provide political guidance, a Geneva-based official told Bridges. These discussions will focus on the importance of the multilateral trading system, along with trade and development.

Russia, government procurement appear on track

Currently, the ministerial conference is widely expected to approve Russia’s long-standing bid to join the WTO; the formal Working Party on Russian accession is scheduled to meet on 10 and 11 November to finalise remaining technical issues. Sources familiar with the talks note that, while there are a fair amount of technical details that are being discussed, there is no issue that seems unlikely to be resolved.

The announcement last week that Russia and its neighbour Georgia had reached a compromise deal resolving their disagreements on trade monitoring along their shared border removed the last major hurdle remaining in Russia’s 18-year accession process (see Bridges Weekly, 2 November 2011). The compromise was largely made possible via the mediation of Switzerland, which trade sources note was “instrumental” in achieving an agreement.

Last month, the chair of the WTO committee on government procurement also announced that the 42 countries currently finalising the Government Procurement Agreement (GPA) talks were quickly approaching the finish line (see Bridges Weekly, 19 October 2011). Unlike the Doha Round of trade talks, the GPA does not extend to the entire WTO membership, applying only to those countries that choose to sign on to the process.

Other countries are also working on acceding to the agreement, notably China. Another meeting of the committee on government procurement is scheduled for 15 November.

Apart from these, “the number of decisions that members take will be small,” one delegate observed, adding wryly that the meeting risks becoming “the least successful ministerial since the last one.”

TRIPS non-violation, e-commerce return to ministerial agenda

Ministers are also expected to take decisions on e-commerce and non-violation complaints under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; both of these topics have featured regularly on previous ministerial agendas.

In the case of e-commerce, ministers will decide whether to extend a moratorium on tariffs on goods sold for download online, such as songs; a ban on these tariffs has been in place since the 1998 Ministerial Conference.

TRIPS non-violation complaints concern whether countries should be allowed to bring WTO disputes on the grounds that the spirit of the organisation’s intellectual property rules has been breached, rather than just the letter of the TRIPS Agreement. A five-year prohibition on such complaints was put in place at the WTO’s founding in 1995, and has been repeatedly extended at ministerial conferences ever since.

Source: (ICTSD) International Centre for Trade and Sustainable Development

http://ictsd.org/i/news/bridgesweekly/117966/

Posted on Categories General News, News 109 Comments on Copyright law and education materials: can the two get along?

Copyright law and education materials: can the two get along?

By Henry Zakumumpa

7th/11/2011

Thousands of school children in rural Uganda are already disadvantaged. Many schools are without libraries and those with libraries have stocks that are outdated with a few over-used and mutilated copies.

It is not uncommon to find there are only a few copies of current text books shared among hundreds of pupils. The cost of one new primary school text book is often the equivalent of a one-month salary for a primary school teacher in Uganda.

Take the case of a remote primary school in Butahe village in Mbarara District, a government-aided school located in south western Uganda; about 400 kilometers from the capital Kampala .There are only two mathematics text books for the 500-plus school population.

Many pupils and teachers use photocopying to get around the hurdle of scarcity of school text books, a practise which is even widespread in Uganda’s burgeoning universities. But that too is no longer an option –at least, a legal option. Photocopying a text book could actually land you in jail.

Under the Copyright and Neighboring Rights Act 2006 it is a criminal offence to photocopy copyrighted material such as school text books. These are mainly published by multinational publishers such as Longman and Macmillan, although local publishers such as Fountain Publishers and MK Publishers are increasing their market share in Uganda, especially for school text books.

“Ugandans don’t have a culture of buying books. Even among those who can afford. For example, a locally-published book costs only 18,000 shs (U$ 7) but students will still want to photocopy. We need to change mindsets,’’ says Dr Ronald Kakungulu who is conducting research commissioned by human rights NGO, the Center for Health and Human Rights Development (CEHURD) on the impact Uganda’s copyright law is having on the right of access to educational materials.

However, the copyright law permits some limited form of photocopying for educational purposes under a vague provision known as ‘fair use’, which permits photocopying only portions of a text book. Also, the ‘flexibilities’ in the copyright law allows the education minister to grant a license for vital education materials to circumvent the rigidities of copyright law.

For many years Ugandan schools and students have been buying Indian-printed versions of Western text books, which are much cheaper. When I was a secondary student of English literature, about 15-years-ago, we could scarcely afford brand-new copies of set texts such as Macbeth and A Man For All Seasons and got by through purchasing cheaper Indian-printed versions. Yet this option is not legally available to current secondary students in Uganda.

This practice of buying cheaper copies of copyrighted books is called ‘parallel importation’. This was legally permitted before the coming into force of the new Ugandan copyright law but is now outlawed.

But the desperate shortage of school text books in the average Ugandan primary school such as the one in Butahe, Mbarara district is as a result of a myriad of factors, which range from intellectual property rights issues to centralized educational material procurement delays.

‘’School curriculums are unstable and keep changing all the time, which makes it expensive for book publishers in Uganda since they have to make new publications too regularly, ‘’ says Peter Kibuuka, a representative of Pearson Longman.

“To be fair, looking exclusively at right of access to educational materials in isolation of the necessary balancing act of protecting publishers who make enormous investments in publishing books would be unsustainable,” counsels Charles Batambuze, executive secretary of the Uganda National Book Trust.

At a workshop organized by the CEHURD in collaboration with Uganda National Book Trust at Hotel Africana in Kampala last Thursday (3 November 2011), stakeholders met to discuss the relationship between Ugandan copyright law and the right to access educational materials. The discussion was chaired by Moses Mulumba, the executive director of CEHURD, who informed workshop participants that low- income countries need not despair and can exercise ‘flexibilities’ under international trade law, which allows for countries to access copyrighted educational materials under a grace period granted until July 2013.

‘’Even reforming our copy right law in Uganda alone is not going to be enough because of East African regional integration efforts. Laws made at the East African level supersede Ugandan laws,’’ said Moses Mulumba.

On efforts to broaden access to education materials, Professor Ikoja Odongo, who attended the CEHURD workshop, said ‘‘we need to take action and not just keep on talking and talking about access to educational materials”.

Professor Ogongo’s call needs to be heeded if school children in remote Ugandan primary schools are to freely access school text books and get an education – a right guaranteed under the 1995 Uganda constitution.

Source: KC team

http://www.keycorrespondents.org/2011/11/07/copy-right-law-and-education-materials-can-the-two-get-along/

Posted on Categories General News 10 Comments on Will the UN backtrack on accessible medicine?

Will the UN backtrack on accessible medicine?

By James Love

A plan to create ‘cancer prizes’ would eliminate patent monopolies for cancer drugs, and instead grant prizes to innovators who create new medicines.

On September 19, the United Nations will convene a high-level meeting to consider the “international aspect of public health” for non-communicable diseases (NCDs), with a particular focus on the social and economic impacts for developing countries.

The UN has been widely praised for undertaking this initiative, and there is considerable support for giving attention to the growing burden of cancer, diabetes, heart disease and other non-communicable diseases, not only in high-income countries, but everywhere. However, some of the issues are controversial, including those relating to intellectual property rights for new medicines, diagnostics and medical devices.

Last week, details of the negotiations were leaked that reveal the UN declaration on NCDs will be used to attack a ten-year-old agreement on intellectual property rights and public health. The controversy involves the November 14, 2001, World Trade Organisation (WTO) Doha Declaration on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and public health. This landmark agreement was agreed upon in Doha, Qatar, during an emotionally charged and tense ministerial meeting of the WTO.

Among other things, the Doha Declaration effectively gave WTO members more flexibility in designing patent and other intellectual property rules, and said that WTO members “should” implement their laws “in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all”.

This agreement was also the basis for subsequent changes in WTO rules on patents that allowed medicines to be exported to countries that lack local manufacturing capacity, and that deferred obligations to enforce pharmaceutical patents in the world’s least developed countries.

In 2001, big drug companies bitterly fought the Doha Declaration, but the Bush Administration, reeling from 9/11 and a subsequent scare over access to medicines to treat anthrax, wanted to build bridges with the international community, and so accepted strong language on public health.

The Doha Declaration came about during a period of great concern over access to patented AIDS drugs. During both the 2001 negotiation and a follow-up WTO negotiation in 2002-2003, Pfizer, Merck, Abbott, and other big drug companies and their lobby groups – such as the Pharmaceutical Research and Manufacturers of America (PhRMA), the International Federation of Pharmaceutical Manufacturers & Associations, and the European Federation of Pharmaceutical Industries and Associations – tried to narrow the Doha Declaration to AIDS and a handful of other infectious diseases, or to exceptional public health emergencies.

The PhRMA position was decisively rejected in the WTO negotiations. Legally, the 2001 Doha Declaration, and subsequent amendments to TRIPS, applies to any disease. But in practice, the perceptions are as important as the legal reality. By continuing to assert that the Doha Declaration is in fact limited in various ways, US and European trade negotiators have tried to discourage the granting of compulsory licenses on patents for high-priced drugs for cancer and other non-communicable diseases.

The term “compulsory license” is used to describe cases in which governments or courts set aside the exclusive rights of a patent, and allow others to use inventions, normally in return for a royalty payment to the patent owner. In such cases, the patent is no longer an absolute monopoly to use the invention, but does ensure that patent owners are paid when the inventions are used by third parties.

The use of compulsory licenses are as old as the patent system itself (a 1474 Venetian statute and an English law passed in 1623 both sanctioned compulsory licenses), and are used in a wide range of cases. While maintaining an active trade policy to prevent developing countries from using compulsory licenses for patents on medicines, at home the United States has used compulsory licenses to expand access to patented inventions to treat cancer, diagnose the Hepatitis C virus, manufacture contact lenses, and treat aortic valve heart disease.

The US has also recently twice granted compulsory licenses to Microsoft for patents on features used in Microsoft Office, and granted compulsory patent licenses to DirectTV, Toyota and other technology firms. The European Union has used compulsory licenses on Microsoft Windows technologies, and Italy has issued several compulsory licenses for pharmaceutical inventions, including one product used to restore hair loss.

When the UN convenes on September 19, it will complete its work on an outcomes resolution. Currently, the European Commission and the White House Office for the United States Trade Representative (USTR) have blocked any mention of the 2001 Doha Declaration, although a “compromise” text makes references to “the full use of TRIPS flexibilities”. The EU trade negotiator believes that the lack of reference to the Doha Declaration will allow them to assert that the 2001 agreement does not apply to non-communicable diseases. Many public health groups have urged delegates to fix this, by restoring the references to the Doha Declaration that the European Commission’s Directorate-General for Trade and the USTR have opposed.

However things play out at the UN high-level meeting on non-communicable diseases, battles over access to new cancer drugs will heat up. In India, an August 30, 2011, request for a compulsory license was filed for patents on the cancer drug Sorafenib (developed and marketed by Bayer and Onyx Pharmaceuticals as Nexavar). The India generics firm CIPLA is expected to soon launch less-expensive generic versions of several drugs, including Trastuzumab (sold by Roche under the trade name Herceptin), a super-expensive but effective treatment for women with a certain type of breast cancer.

Developing countries cannot improve access to cancer drugs unless they grant more compulsory licenses on patents, or undertake more fundamental and radical changes in the way research and development (R&D) for cancer drugs is financed.

Prize funds

In 2009, Bangladesh, Bolivia and Suriname asked the World Health Organisation to hold a meeting to consider an entirely new way to address paying for R&D for cancer drugs. Rather than depend upon 20-year patent monopolies, they proposed de-linking drug prices from R&D incentives. All monopolies for cancer drugs would be eliminated, so that drugs could be purchased at generic prices. To reward R&D, countries would put a percentage of their cancer treatment budgets into new innovation prize funds.

This proposal was entitled, “Prizes as a Reward Mechanism for New Cancer Treatments and Vaccines in Developing Countries. It was based upon ideas first put forth by Thai public health officials, who were struggling to expand access to newer cancer drugs, but were under intensive pressure from the US government to leave the patent monopoly intact.

Under the cancer prize approach, access to expensive drugs would give health authorities greater incentives to invest in the diagnosis and treatments for cancer. As outlays on cancer health care rise, countries would allocate more money for innovation prize rewards. Countries with higher incomes and greater investments in care would contribute more.

The cancer prize fund approach is also being considered in Europe. There are huge income differences between Eastern Europe and Northern Europe, and it is much easier to de-link incentives from drug prices than to manage a system of negotiating affordable prices country by country.

At first, the cancer prize fund proposal was so controversial that the World Health Organisation at first refused to publish it on its website. And in 2010, the proposal was ignored by a WHO expert group on R&D financing. But after the first WHO expert group was criticised for its pro-industry report, a second group of experts was appointed, and the cancer prize fund approach is now being re-evaluated.

The UN is being asked to backtrack from an important agreement to put “access to medicine for all” at the centre of trade policy. This comes at the same time that the United States and Europe are involved in all sorts of regional and bilateral trade negotiations that ratchet up intellectual property protections, making it harder to obtain affordable generic medicines. Inequalities of access to medicine and healthcare are already shocking, and these trade pressures just make things worse. Negotiators at the UN meetings, public health groups, politicians, and the public need to push back and demand changes in global trade negotiations.

We need to move away from lobbyist-driven policies that pit innovation against access, to a new trade policy that reconciles both objectives. Eyes will turn next to the recommendations of the World Health Organsation’s Consultative Expert Working Group on R&D, to see if this can jump-start a new direction in global negotiations – one that puts people and human rights at the center of patent policy.

Source: Al jazeera

http://english.aljazeera.net/indepth/opinion/2011/09/201191492714279493.html

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