[CTC] Text and more statements on recent TRIPS proposal

Tue Mar 15 18:21:04 PDT 2022

Here and below is text of the recent TRIPS proposal: http://freepdfhosting.com/4d79fc6c70.pdf <http://freepdfhosting.com/4d79fc6c70.pdf>

Some additional statements:

“This compromise is not nearly good enough,” said Brook Baker, a Northeastern University professor who specializes in access to medicines and intellectual property and is a senior policy analyst for Health GAP. “It does not deliver either the vaccine technology nor therapeutics or diagnostics. The history of the WTO is littered with promises that are not delivered. Why do we have to wait? It makes no sense. There’s no cause for celebration. They should all get back to work.”

===

STATEMENT FROM USTR SPOKESPERSON ADAM HODGE ON THE WTO TRIPS WAIVER DISCUSSIONS

Since last May, USTR has worked hard to facilitate an outcome on intellectual property that can achieve consensus across the 164 Members of the World Trade Organization to help end the pandemic. USTR joined informal discussions led by the WTO Secretariat with South Africa, India, and the European Union (EU) to try to break the deadlock.

The difficult and protracted process has resulted in a compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome. While no agreement on text has been reached and we are in the process of consulting on the outcome, the U.S. will continue to engage with WTO Members as part of the Biden-Harris Administration’s comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible.

###

===

Statement: Leaked Proposal on COVID Medicines Waiver Helps No One But Floundering WTO

WASHINGTON, DC — According to Politico EU <https://twitter.com/ashleighfurlong/status/1503799100214583300>, a supposed “compromise” has emerged from the “quad” negotiations among the United States, European Union and waiver sponsors India and South Africa around the waiver of World Trade Organization (WTO) intellectual property rights for COVID-19 products. Melinda St. Louis, director of Public Citizen’s Global Trade Watch division, issued the following statement:

The WTO has delayed action for two years, when it should have removed all its constraints on COVID medicines and medical tool production on day one. Now a new WTO proposal would fail to advance global access to COVID-related health technologies and may actually mark a setback from existing rules. As reported, this proposal would help no one but the floundering WTO and should be rejected.

Among its key limitations: the proposal appears to cover only vaccines (not tests and treatments), cover only patents (not other important intellectual property barriers), be limited geographically, and further undermine current WTO flexibilities for compulsory licenses.

No doubt some at the WTO are feeling pressure to make a deal on the waiver before the WTO Ministerial scheduled for the week of June 13, but it would be a mistake for WTO members to prematurely agree to a weakened waiver that provides political cover to the U.S. and EU while not making any meaningful difference in increasing access to vaccines, tests and treatments. No waiver is better than a weak waiver designed solely to save face. 

The text is not yet available, but reports indicate this proposal represents the worst elements of both the U.S. and EU positions. This must not be accepted by WTO members.

Worst of the U.S. Position: The proposal is for vaccines only, excluding tests and treatments.

The longstanding U.S. position to support a waiver for vaccines only, excluding the tests and therapeutics, is shameful, particularly as President Biden recently lauded testing and treatment as key tools in fighting the pandemic at this stage.

The new proposal only covers vaccines, with tests and treatments to be considered six months after the proposal is agreed, if it is agreed. Given the already seventeen-month delay since the waiver was introduced, it is irresponsible to suggest further delay for tests and therapeutics, as we know that testing and therapeutics are desperately needed now, and with the WTO’s track record, would likely never happen. Civil society organizations — including Doctors Without Borders, Health GAP and the Association of Flight Attendants, among many others — have made clear <https://healthgap.org/wp-content/uploads/2021/06/Dear-Ambassador-Katherine-Tai.pdf> they “strongly disagree with any effort to limit the waiver to one health technology only.” Precisely which therapeutics that Americans can access should people in the Global South be denied? 

Worst of the U.S. Position: The proposal limits the waiver’s geographic scope.

The U.S. had also reportedly <https://genevahealthfiles.substack.com/p/efforts-to-narrow-the-trips-waiver?s=r> suggested limiting the geographic scope of the waiver, which would only further limit the ability to scale up manufacturing all over the world. This demand was apparently agreed, as the proposal now on offer would only apply to developing countries that contributed less than 10 % of the world’s exports of COVID-19 vaccine doses in 2021.

Worst of the EU Position: The proposal is for patents only, ignoring other forms of IP.

The European Union has been the primary obstacle <https://www.citizen.org/wp-content/uploads/Analysis-EU-proposal-with-header-and-intro-.pdf> to progress on the waiver, even though many of its member states support the proposal, and the European Parliament has approved three formal calls for a comprehensive waiver. The EU’s position had been to basically restate existing WTO flexibilities on patents that almost every WTO member already has, while requiring additional conditionalities. The Politico story that broke the news of the proposal mentions patents repeatedly, but not the other categories of intellectual property addressed in the original waiver proposal: copyright, trade secrets, undisclosed data and industrial design. Many key COVID-19 vaccines and medicines are protected by thorny thickets of intertwined IP protection, not just a patent or two. If the proposal is for patents only, it is extremely disappointing that the U.S. caved on its longstanding position to support the waiver for all categories of IP (at least for vaccines).

Worst of the EU Position: The proposal has little new to offer.

Any proposal that follows the EU position is worse than no action at all, because it could further undermine current WTO rules that already allow governments to issue compulsory licenses. The need for far greater, not less, freedom to make and use medicines in a global health crisis like the COVID-19 pandemic is precisely why more than 100 countries have supported the waiver as introduced by India and South Africa.

###

===

Leaked Draft WTO COVID Text Would Not Improve Access to Vaccines,
Altogether Excludes Treatments and Tests

Washington, D.C. – The American Economic Liberties Project released the following statement in response to reports <https://t.co/cllrhh0FJV> regarding text related to negotiations on WTO intellectual property barriers that block global access to needed supplies of COVID-19 vaccines, treatments and tests.

“Absent substantial improvements, the current approach would fail President Biden’s righteous mission of increasing access to vaccines to end the COVID crisis,” said Lori Wallach, Director of Rethink Trade at the American Economic Liberties Project.

“It seems to represent the lowest common denominator of EU fealty to Big Pharma by not waiving intellectual property monopolies and the U.S. insistence that only vaccines be considered despite the new lifesaving treatments that President Biden spotlights as critical to dealing with COVID.

“It sounds like the demand for a waiver of IP barriers limiting COVID medicine access led by South Africa and India and supported by the US and 70 other countries is being crushed by Big Pharma and their advocates in Europe. 

“Instead of a waiver, it sounds like a reiteration of existing WTO rules for patent compulsory licensing that is widely considered to be unsuited to the COVID mission and that fails to cover most forms of IP at all. Once text becomes public, we will see if the new cumbersome conditions to compulsory licensing previously proposed by the EU are included, which would make matters worse than the already untenable status quo of WTO barriers to medicine access,” added Wallach.

To learn more, see a recent Rethink Trade event “Taking on Big Pharma Monopolies to End the Pandemic <https://youtu.be/G2p0rGUHl1o>.”

Learn more about Economic Liberties and Rethink Trade here <https://www.economicliberties.us/>. 

###

QUAD’s tentative agreement on TRIPS and COVID 19
Posted on March 15, 2022 <https://www.keionline.org/37544> by James Love <https://www.keionline.org/author/james-love>
Ed Silverman of Stat has a story on the QUAD deal on TRIPS.

https://www.statnews.com/pharmalot/2022/03/15/covid19-vaccine-patents-wto/ <https://www.statnews.com/pharmalot/2022/03/15/covid19-vaccine-patents-wto/>
Ed links to a document which sets out the proposal (see below).

It is a very limited and narrow agreement.  It only covers vaccines, it limits “eligible members” to developing countries, and only those who exported less than 10 percent of world experts in 2021 (China is excluded).

Countries are required to follow Article 31 of the TRIPS, which of course, is an existing and not a new flexibility, but with “clarifications” and a partial waiver of 31.f.  

The clarifications are actually new obligations on countries that do not presently exist in Article 31. With the exception of the partial waiver of paragraph f in Article 31 (exports to “eligible countries”), the agreement makes Article 31 more restrictive and burdensome.  In other words, outside 31.f, the agreement makes Article 31 worse.  

For example, there is a new obligation to identify all patents covered by the authorization, something not required now in TRIPS, and not even the practice in the United States for 28 U.S.C. 1498(a) cases.  There is a new obligation to notify the WTO of use of the waiver, something not required for compulsory licenses in general.  

Particularly galling given that the agreement concerns vaccines is that only the 3rd paragraph of Article 39 is addressed, and the concession is essentially a statement of existing flexibilities. The Article 39 provisions most relevant to trade secrets and manufacturing-know are paragraph 1 and 2, and they are not included.

Overall, this agreement will be welcomed by PhRMA members, if it ends the conversation about IP and the pandemic at the WTO. 

Here is the text published by Stat:

—————

TRIPS COVID-19 solution (the outcome of the quadrilateral discussions at the end of last week, to be presented to WTO Members)

1. Notwithstanding the provision of patent rights under its domestic legislation, an eligible Member1 may limit the rights provided for under Article 28.1 of the TRIPS Agreement (hereinafter “the Agreement”) by authorizing the use of patented subject matter2 required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic, in accordance with the provisions of Article 31 of the Agreement, as clarified and waived in paragraphs 2 to 6 below.

2. For greater clarity, an eligible Member may authorize the use of patented subject matter under Article 31 without the right holder’s consent through any instrument available in the law of the Member such as executive orders, emergency decrees, government use authorizations, and judicial or administrative orders, whether or not a Member has a compulsory license regime in place. For the purpose of this Decision, the ” law of a Member” referred to in Article 31 is not limited to legislative acts such as those laying down rules on compulsory licensing, but it also includes other acts, such as executive orders, emergency decrees, and judicial or administrative orders.

3. Members agree on the following clarifications and waivers for eligible Members to authorize the use of patented subject matter in accordance with paragraphs 1 and 2:

(a) With respect to Article 31(a), an eligible Member may issue a single authorization to use the subject matter of multiple patents necessary for the production or supply of a COVID-19 vaccine. The authorization shall list all patents covered. In the determination of the relevant patents, an eligible Member may be assisted by WIPO’s patent landscaping work, including on underlying technologies on COVID-19 vaccines, and by other relevant sources. An eligible Member may update the authorization to include other patents.

(b) An eligible Member need not require the proposed user of the patented subject matter to make efforts to obtain an authorization from the right holder for the purposes of Article 31(b).

(c) An eligible Member may waive the requirement of Article 31(f) that authorized use under Article 31 be predominantly to supply its domestic market and may allow any proportion of the authorized use to be exported to eligible Members and to supply international or regional joint initiatives that aim to ensure the equitable access of eligible Members to the COVID-19 vaccine covered by the authorization.

(d) Eligible Members shall undertake all reasonable efforts to prevent the re-exportation of the COVID-19 vaccine that has been imported into their territories under this Decision. All Members shall ensure the availability of effective legal remedies to prevent the importation into their territories of COVID-19 vaccines produced under, and diverted to their markets inconsistently with, this Decision.

(e) Determination of adequate remuneration under Article 31(h) may take account of the humanitarian and not-for-profit purpose of specific vaccine distribution programs aimed at providing equitable access to COVID-19 vaccines in order to support manufacturers in eligible Members to produce and supply these vaccines at affordable prices for eligible Members. In setting the adequate remuneration in these cases, eligible Members may take into consideration existing good practices in instances of national emergencies, pandemics, or similar circumstances.3

4. Nothing in Article 39.3 of the Agreement shall prevent a Member from taking measures necessary to enable the effectiveness of any authorization issued as per this Decision.

5. For purposes of transparency, as soon as possible after the adoption of the measure, an eligible Member shall communicate to the Council for TRIPS any measure related to the implementation of this Decision, including the granting of an authorization.4

6. An eligible Member may apply the provisions of this Decision until [3][5] years from the date of this Decision. The General Council may extend such a period taking into consideration the exceptional circumstances of the COVID-19 pandemic. The General Council will review annually the operation of this Decision.

7. Members shall not challenge any measures taken in conformity with this Decision under subparagraphs 1(b) and 1(c) of Article XXIII of the GATT 1994.

8. No later than six months from the date of this Decision, Members will decide on its extension to cover the production and distribution of COVID-19 diagnostics and therapeutics.

FOOTNOTES

1 For the purpose of this Decision, an “eligible Member” means any developing country Member that exported less than 10 percent of world exports of COVID-19 vaccine doses in 2021.

2 For the purpose of this Decision, it is understood that ‘patented subject matter’ includes ingredients and processes necessary for the manufacture of the COVID-19 vaccine.

3 This includes the Remuneration Guidelines for Non-Voluntary Use of a Patent on Medical Technologies published by the WHO (WHO/TCM/2005.1)

4 The information provided shall include the name and address of the authorized entity, the product(s) for which the authorization has been granted and the duration of the authorization. The quantity(ies) for which the authorization has been granted and the country(ies) to which the product(s) is(are) to be supplied shall be notified as soon as possible after the information is available

—
James Love

Arthur Stamoulis
Citizens Trade Campaign
(202) 494-8826

-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://lists.citizenstrade.org/pipermail/ctcfield-citizenstrade.org/attachments/20220315/80f00cfa/attachment.html>