[Ip-health] Pink Sheet article on the LDC drug patent waiver negotiation.

[Ellen 't Hoen]

It is interesting to see the contrast with the European manufacturers (EFPIA) position in support of the LDC request:

http://www.efpia.eu/mediaroom/297/43/EFPIA-Statement-on-Commission-Support-for-the-Exemption-of-LDCs-from-World-Trade-Organization-intellectual-property-rules-for-pharma <http://www.efpia.eu/mediaroom/297/43/EFPIA-Statement-on-Commission-Support-for-the-Exemption-of-LDCs-from-World-Trade-Organization-intellectual-property-rules-for-pharma>

 
—————————————————————
Ellen 't Hoen, LLM | Medicines Law & Policy
phone: +33 (0)695048388
e-mail: ellenthoen at medicineslawandpolicy.net <mailto:ellenthoen at medicineslawandpolicy.net>
twitter:@ellenthoen
skype: efmthoen




> On 15 Oct 2015, at 01:35, Jamie Love <james.love at keionline.org> wrote:
> 
> The Pink Sheet has an article on the LDC drug patent waiver negotiation.
> 
>  *  It quotes PhRMA's position on the waiver issue as follows:
> 
> -----------
> "We believe strongly that robust IP enforcement and protection is essential
> to driving innovation and economic growth in developing and developed
> countries, " PhRMA spokesperson Mark Grayson said. He added that the
> association believes full implementation of TRIPS by all parties "should be
> time based."
> ----------
> 
> *   The article makes reference NGOs claiming USTR has told WTO negotiators
> it wants to block the LDC drug patent waiver in order to avoid further
> conflicts with PhRMA.
> 
> *  The Pink Sheet says the White House declined to comment on the issue.
> 
> *  The article quotes the European Commission in support of a permanent WTO
> drug patent waiver, and notes that several members of the US congress
> support the permanent waiver.
> 
> *  The article notes UNDP and UNAIDS both support the permanent waiver.
> 
> 
> ----------------------
> Global Patents: Poorest Countries Seek Permanent Waiver; PhRMA Wants Time
> Limit
> 
> By Brenda Sandburg
> 
> October 13 2015
> 
> Executive Summary
> 
> World Trade Organization to hear request by least developed countries for
> exemption from pharmaceutical patent protections until they lose LDC
> status; current waiver under TRIPS expires Jan. 1.
> 
> There is a fierce campaign by a group of least developed countries – backed
> by the European Commission, members of Congress and nongovernmental
> organizations – to obtain permanent exemption from issuing pharmaceutical
> patents as long as they hold least developed status.
> 
> The group submitted the request to the World Trade Organization, which is
> to take it up during the WTO’s TRIPS Council meeting in Geneva Oct. 15-16.
> Least developed countries (LDCs) are currently exempt from the
> pharmaceutical patent obligations of the Trade-Related Aspects of
> Intellectual Property Rights (TRIPS) agreement under a transition period
> that is set to expire on Jan. 1. In force since 1995, the TRIPS agreement
> requires WTO member countries to follow minimum standards for protecting
> and enforcing IP rights.
> 
> There are currently 48 countries designated as LDCs, 34 of which are
> members of WTO.
> 
> The Pharmaceutical Research and Manufacturers of America is not opposed to
> extending the waiver but believes there should be a time limit. LDCs are
> exempt from TRIPS requirements broadly until 2021.
> 
> "We believe strongly that robust IP enforcement and protection is essential
> to driving innovation and economic growth in developing and developed
> countries, " PhRMA spokesperson Mark Grayson said. He added that the
> association believes full implementation of TRIPS by all parties "should be
> time based."
> 
> US Opposition Follows Concessions On Trade Deal, MSF Says
> 
> Médecins Sans Frontières and the nongovernmental group Knowledge Ecology
> International have reported that the United States is opposed to the
> permanent exemption. MSF linked US opposition to the concessions it made in
> negotiating the Trans-Pacific Partnership (TPP) agreement. The trade pact
> aims to provide eight years of biologics data protection rather than the 12
> years industry sought ("Trade Deal Looking Worse For Pharma As More Details
> Emerge" — "The Pink Sheet" DAILY,Oct. 9, 2015). "Information has emerged
> that US Ambassador to the World Trade Organization, Michael Punke, met with
> representatives of 15 LDCs last Friday in Geneva, where he noted that the
> US could not agree to an indefinite exemption due to pressure from some US
> stakeholders who are upset with the US government’s intellectual property
> concessions on the recently-completed Trans-Pacific Partnership trade
> agreement," MSF said in an Oct. 12 release.
> 
> The White House did not immediately respond to a request for the
> administration’s views on the waiver request. Grayson said PhRMA does not
> know anything about the meeting cited by MSF.
> 
> James Love, director of Knowledge Ecology International, said a temporary
> waiver will not be useful because countries will not amend their patent
> laws to eliminate infringement liability unless the waiver is permanent.
> "It is a consequential negotiation," Love stated. "About a billion people
> would be in the patent free zone with regard to pharmaceuticals."
> 
> Bangladesh Has Launched Generic Sovaldi
> 
> The exemption request was put forward by Bangladesh on behalf of the LDC
> group and formally presented to the WTO’s TRIPS Council in June. At that
> time the World Health Organization urged the council to favorably consider
> the request. It said that being exempted from granting patents allows least
> developed countries to either locally produce or to import generic products
> even when they are still under patent in other countries. The European
> Commission issued a statement on Sept. 10 saying it agreed to support the
> least developed countries’ call for easier access to cheaper medicines by
> means of an indefinite exemption from WTO intellectual property rules for
> pharmaceuticals.
> 
> "This exemption allows generic medicines to be imported, and produced
> locally, regardless of patents, for example when licenses are not
> available. It means producers of generics and international programmes can
> supply drugs like HIV treatment in affected countries without fear of
> patent infringement suits," the EC stated.
> 
> The United Nations Development Programme and the Joint United Nations
> Programme on HIV/AIDS also back exemption of countries from patent and
> clinical trial data protections until they are no longer deemed least
> developed. The UN groups noted in a May 21 statement that access to
> medicines like Gilead Sciences Inc.’s hepatitis C treatment Sovaldi
> (sofosbuvir) "remains a grave challenge in LDCs because of high prices."
> 
> They said the drug could cost as much as $84,000 for a 12-week course in
> developed countries and that while lower prices via generic licenses are
> being offered by the patent holder in some developing countries, the cost
> still places a burden on health budgets. They noted that Bangladesh had
> taken advantage of its LDC status to launch its own version of the drug for
> $900 for a 12-week course.
> 
> Sen. Sanders, House Reps Support Waiver
> 
> On Oct. 2, seven Democratic members of the US House of Representatives sent
> a letter to US Trade Representative Michael Froman calling for a waiver of
> WTO obligations to grant and enforce pharmaceutical patents until a country
> is no longer classified as an LDC.
> 
> The 48 LDCs represent nearly 13% of the world’s population but only about
> 1% of the world’s income, with an average $928 per capita income in 2014,
> the letter notes. Signatories include Reps. Jan Schakowsky, D-Ill., Rosa
> DeLauro, D-Conn., Barbara Lee, D-Calif., and Jim McDermott, D-Wash.
> 
> Senator and Democratic presidential candidate Bernie Sanders, I-Vt., also
> sent Froman a letter voicing support for the LDC group’s request.
> 
> The International Federation of Pharmaceutical Manufacturers & Associations
> issued a statement saying it supported the existing waiver for LDC
> implementation of the entire TRIPS agreement until 2021 and that
> "additional waivers or extension do not appear to be necessary at this
> stage." According to KEI, Australia, Canada, and Switzerland also oppose
> indefinite exemption.
> 
> 
> -- 
> James Love.  Knowledge Ecology International
> http://www.keionline.org/donate.html
> KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
> +41.76.413.6584, twitter.com/jamie_love
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