Author: Sangeeta-Shashikant

World Health Assembly to Discuss UN High Level Report on Access to Medicines

[Reposted from the Third World Network, Link] The forthcoming 70th World Health Assembly (WHA) will discuss access to medicines including the United Nations Secretary General’s High Level Panel Report on Access to Medicines (UNHLP report). The inclusion of this agenda item has been a topic for debate and the 140th meeting of the Executive Board of the World Health Organization (WHO) finally agreed to accordingly amend an existing agenda item on shortage of medicines of the 70th WHA that will convene in May this year. The Executive Board is composed of 34 WHO members on a rotation basis, primarily mandated to facilitate the work of the WHA. It met at the WHO headquarters in Geneva from 23 to 31 January 2017. The Board’s move follows a proposal by Eritrea on behalf of the Africa Group to have on the agenda of the WHA a stand-alone agenda item on access to medicines to give WHO Members an opportunity to deliberate on the problems Member States face on access to medicines. However, Eritrea’s proposal was not agreeable to the Chairman of the Executive Board, Ray Busuttil from Malta who instead proposed re-naming agenda item 14.3 of the WHA from “Addressing the global shortage of medicines and vaccines” to “Addressing the global shortage and access to medicines and vaccines”. The agenda item debate was essentially about the UNHLP report which was not...

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World Health Organization Member State Mechanism Agrees to Drop “Counterfeit” Term

[Third World Network, Link] The World Health Organization (WHO) Member State Mechanism (MSM) on substandard/spurious/falsely-labelled /falsified/counterfeit medical products (SSFFC) has agreed to recommend to the World Health Assembly (WHA) to drop the term “counterfeit” to refer to quality-compromised medical products. This decision was taken by the MSM in the context of refining the SSFFC definitions utilized by WHO, during its fifth meeting here on 23-25 November. This historic agreement follows years of often-intense dispute among WHO member states as to the appropriate terminologies that should be utilized to refer to unsafe medical products circulated by unscrupulous actors. The recommendation, when endorsed by the WHA, will put an end to nearly 30 years of practice in WHO of using the term “counterfeit” when referring to quality-compromised medicines. The MSM agreed that the “term ‘counterfeit’ is now usually defined and associated with the protection of intellectual property rights”, acknowledging the definition of “trademark counterfeit goods” included in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Intellectual property (IP) considerations are expressly outside the mandate of the MSM, which has as its main objective “the prevention and control of substandard/spurious/falsely-labelled/falsified/counterfeit medical products and associated activities”, “in order to protect public health and promote access to affordable, safe, efficacious and quality medical products”. The MSM further agreed that “[i]n the context of medical products, the term ‘falsified’...

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Unconditional 17-Year Exemption from Pharmaceuticals Patents Agreed

[Reposted from the Third World Network, Link] The United States and the Least Developed Countries (LDCs) at the World Trade Organization have reached agreement ad referendum on a pharmaceutical patent exemption for a duration of 17 years, according to trade diplomats. With this exemption, the world’s poorest nations will not be obliged “to implement or apply” or “to enforce” patents as well as test data protection for pharmaceutical products until 1 January 2033. This agreement was reached during a high level meeting on 29October between US Ambassador Michael Punke and representatives of the LDC Group, Ambassador Shameem Ahsan from Bangladesh and Ambassador Christopher Onyanga Aparr from Uganda. As part of the agreement, the LDC Group also secured waivers from ‘mailbox’ and exclusive marketing right obligations, a trade diplomat said, adding that there were no restrictive conditions attached to the decision text. With these waivers, LDCs will not be obliged to make available a mechanism for filing patent applications for pharmaceutical products (mailbox) or to grant exclusive marketing rights to such applications until 1 January 2033, although the waivers would have to be reviewed by the WTO General Council annually. Trade diplomats expect a decision text based on this agreement to be formally adopted by the Council of the Trade-related Aspects of Intellectual Property Rights (TRIPS) when it meets this Friday (6 November) at 10 am at the WTO.  The...

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US Stands in the Way of LDCs’ Pharmaceutical Transition Period

[Cross posted from the TWN Info Service on Intellectual Property Issues, Link] As the World Trade Organization’s intellectual property body begins its session today, there is emerging consensus among the organization’s members that the poorest nations in the world, the least developed countries (LDCs), should not have to apply or enforce pharmaceutical product patents or to implement ‘mailbox’ or exclusive marketing rights for as long as they remain LDCs. The WTO Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) Council is meeting in Geneva on 15-16 October. However, whether or not these vulnerable nations will clinch their desired demands very much depends on the United States, which remains opposed to LDCs’ requests. A trade diplomat told Third World Network (TWN) that, “we have given the US concrete arguments, facts and figures supporting the LDCs’ requests, what else do they need” adding that its now a “political decision”.  Trade diplomats also informed TWN that the matter is now to be discussed at the Ambassadorial level between the US and the LDC Group. Earlier this year, the WTO LDC Group submitted as required by Article 66.1 of the TRIPS Agreement, a “duly motivated request” (IP/C/W/605) seeking an extension of the pharmaceutical transition period for as long as a country remains a LDC, as well as waivers from the mailbox and exclusive marketing rights obligation. The LDC Group’s request is aimed at...

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The African Regional Intellectual Property Organization (ARIPO) Protocol on Patents: Implications for Access to Medicines

Research Paper 56. South Centre. LINK TO FULL PAPER on SOUTHCENTRE.INT Executive Summary: Sub-Saharan Africa (SSA) suffers from numerous communicable and non-communicable diseases, with significant socio-economic effects, and adversely impacting the development prospects of countries in sub-Saharan Africa. Many of these diseases are treatable but access to affordable medicines remains a huge challenge in the region. A particular obstacle to access to medicines is the high, prohibitive costs of medicines enabled by the existence of patents. Patents grant the right holder a monopoly on the patented pharmaceutical for at least 20 years from the date of filing of the patent application, thereby curtailing competition by giving the patent holder freedom to set prices, which in many instances is simply unaffordable to persons who need the medicines. Competition from generic producers has been instrumental in bringing down the cost of medicines and in scaling up treatment; however such competition is only possible in an environment where patents are not obstacles. Patenting of pharmaceuticals became globalized with the coming into force of the Agreement on Trade-Related Aspects of Intellectual Property Rights (commonly referred to as the “TRIPS Agreement) in the World Trade Organization (WTO) in 1995, which set out minimum standards on intellectual property including on patents, which WTO members have to comply with. The pressure to incorporate intellectual property protection within WTO came from a group of mainly developed countries....

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NGOs Condemn the EU Press Release on TRIPS Extension for Least Developed Countries

Joint Statement by 26 NGOs, June 21, 2013 [PDF] On 11th June 2013, the WTO TRIPS Council took a decision (IP/C/64) to extend for a further 8 years, the flexibility of least developed country (LDC) Members under Article 66.1 to not apply the provisions of the TRIPS[1] Agreement except for Articles 3, 4 and 5 (which concern national treatment and most-favored nation treatment). This decision was taken in response to the “duly motivated request” submitted by Haiti on behalf of the LDC Group last November, seeking an unconditional extension for as long as a WTO Member remains a LDC.   This decision was a compromise deal as the EU and US exerted intense pressure on the LDCs to accept conditionalities that are not in favour of the people in theLDCs. The European Union in its press release on 11 June 2013 (“the release”), welcomes the TRIPS Council Decision, but it also makes several inaccurate and misleading statements. 1.  The release claims that the EU: “From the outset of discussions has recognized the importance of flexibility for least developed countries (LDCs) and supported an extension to the transition period”. Contrary to its claim of support, throughout months of behind-the-scenes negotiations, the EU consistently sought to undermine both the requested length of the transition period and LDCs’ freedom to determine the level of IP protection, if any, that was optimal in...

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Controversy Over Patent Rights and the Middle Eastern Respiratory Syndrome Virus

An investigation conducted by Edward Hammond, consultant researcher of Third World Network, has revealed that a leading medical centre in The Netherlands is using a material transfer agreement (MTA) that claims proprietary rights over the Middle Eastern Respiratory Syndrome (MERS) virus, contrary to their public denial of placing restrictions on the virus. The Erasmus Medical Centre issued a press statement on 24 May in response to public criticism by the World Health Organization’s Director General, Dr. Margaret Chan, on 23 May of the Erasmus MTA. A copy of the MTA was obtained by Third World Network some weeks ago under the public records law of the North Carolina, the United States, as part of our ongoing research into potential biopiracy of the MERS virus, triggered by a media report of criticism by Saudi Arabia’s Deputy Minister of Health of Erasmus on this matter. Due to the growing controversy and widespread public interest, Third World Network is now distributing the MTA, which is a public record. TWN has published a research note with more details. The MTA is available here. For more details please contact: Edward Hammond at...

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US and EU Demand TRIPS-Plus Concession from Poorest Countries

Developed countries, particularly the United States and the European Union, have offered a poor and impractical deal of an incredibly short extension of 5 years with restrictive conditions to least developed countries that are entitled to be exempted from implementing the WTO TRIPS Agreement. Particularly problematic is their demand that the LDCs agree to a “no-roll-back” clause, a TRIPS plus condition that will prevent LDCs from rolling back  (i.e. providing a reduced degree of IP protection) their current laws, even if they adversely impact their development concerns. The US and EU are also insisting to include in the extension decision a section on  need-assessment on IP, to facilitate implementation of TRIPS standards. According to sources, this deal was offered in informal consultations between developed countries (US, EU and Japan) and the LDCs coordinated by Australia. The last such consultation took place on Friday, 26 April. Last November the LDCs exercised their legal rights under the TRIPS rules, and submitted a request to the TRIPS Council requesting an unconditional extension of the transition period for as long as a country remains an LDC.  The current transition period expires on 1 July 2013. Article 66.1 of the TRIPS Agreement grants LDCs a renewable exemption from TRIPS obligations. The rationale is that LDCs need maximum flexibility to develop a viable technological base and address their constraints, and that the standard of TRIPS...

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New Seed Legislation Spells Disaster for Farmers in Africa

Civil society organisations from the SADC region, and around the world have condemned the SADC draft Protocol for the Protection of New Varieties of Plants (Plant Breeders’ Rights) as spelling disaster for small farmers and food security in the region. These groups, representing millions of farmers in Africa and around the world have submitted their concerns to the SADC Secretariat. They are calling for the rejection of the Protocol and urgent consultations with farmers, farmer movements and civil society before it’s too late. According to the groups, the Protocol is inflexible, restrictive and imposes a “one-size-fits-all” plant variety protection (PVP) system on all SADC countries irrespective of the nature of agricultural systems, social and economic development. It is modeled after the 1991 International Convention for the Protection of New Varieties of Plants (UPOV 1991), an instrument which was developed by industrialized countries to address their own needs. UPOV 1991 grants extremely strong intellectual property right protection to plant breeders, and disallows farmers from continuing their customary practices of freely using, exchanging and selling farm-saved seeds. According to Moses Shaha, regional chairman for the East and Southern African small-scale Farmers’ Forum (ESAFF): “The proposed legislation gives big-business breeders significant rights, but in doing so, disregards and marginalizes small farmers and their plant varieties. It fails to recognize that small-scale farmers and their customary practices of freely exchanging and re-using seed...

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Letter from 376 Civil Society Groups Supporting an Extension of the TRIPS Waiver for Least Developed Countries

Attached here is a letter from hundreds of civil society groups (representing millions of people worldwide) to members of the World Trade Organisation (WTO) urging them to support the request and draft decision text proposed by the Least developed Countries (LDCs) to the WTO on extending the waiver that exempts LDCs from implementing the WTO-TRIPS agreement until they “graduate” from LDC status. A lot is at stake for LDCs as TRIPS rules undermine human rights,development and health in developing countries. LDCs being the most vulnerable community should not be required to provide and maintain monopolies on essential goods. The TRIPS Council will meet next week (5-6 March) to discuss this matter. There are indications that developed countries (US, EU, Australia etc) would like to severely limit the extension available to LDCs and focus more on LDCs’ compliance with IP rules in the TRIPS Agreement. Please support by: Forwarding the Civil Society letter to government officials and stressing that they have a legal obligation to unconditionally grant the LDCs their request. Bringing this to the attention of media… the last thing that US and other negotiators who are looking undermine this want is “Attention.” Attached here is A simple fact sheet highlighting the implications for LDCs The Civil society letter (in English and in French) supporting the request The CSO letters are also available at www.twnside.org.sg...

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Letter to WIPO From 45 Civil Society Groups: IP Enforcement

The letter below was sent to Mr. Francis Gurry on 30th November 2011. The contents were also communicated during the Advisory Committee on Enforcement that met on 30th November to 1st December 2011.

Regards,
Sangeeta Shashikant
Third World Network

…Today it is widely known that proponents of a “maximalist agenda” on intellectual property (made up of OECD businesses and governments) are on a campaign to increase IP protection and enforcement far beyond the minimum standards of the TRIPS Agreements in ways that are “TRIPS-Plus-Plus”.[1] However such an approach disregards the development dimension, undermines public interests and compromises fundamental human rights such freedom of expression over the internet.[2] …

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