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TWN
Info Service on Health Issues (Jun22/01) Geneva, 6 June (TWN) – Since the start of text-based negotiations on the World Trade Organization Director-General’s text (DG’s text) on the COVID-19 TRIPS decision (the Decision) the United Kingdom and Switzerland, with European Union support, are making constant attempts to limit the scope of the decision. Working in concert, a series of amendments have been proposed to the DG’s text to first limit the scope of the decision, and then additionally to narrow the scope of the only waiver in the text. Secondly, to limit application of the Decision specifically to the acts of production, exportation and importation, without explicitly mentioning the act of “using” for domestic purposes. Thirdly, to nullify the existing flexibility related to protection of undisclosed information under Article 39.3 of the TRIPS Agreement. Fourthly, to impose an obligation to notify the TRIPS Council prior to the shipment of vaccines produced under the Decision. Limiting the Scope of the Decision The DG’s text used the term ‘patented subject matter’, which has been changed to ‘subject matter of patent’ in the course of negotiations to reflect language used in Article 31 of the TRIPS Agreement which is about granting licenses to third parties without the consent of the patent holder (also commonly referred to as “non-voluntary license” or “compulsory license”). With this change, the definition of “subject matter of a patent” as reflected in Footnote 2 of the DG’s text becomes non-exhaustive: “For the purpose of this Decision, it is understood that ‘subject matter of a patent’ includes ingredients and processes necessary for the manufacture of the COVID-19 vaccine.” A developing country sought the deletion of “necessary” for it imposes a “necessity” test, that difficult to prove in the WTO. The UK made several regressive proposals aimed at creating an exhaustive list of “patented” subject matter for which a non-voluntary license may be issued under the Decision, even though determining the patent landscape of any aspect of a vaccine is a Herculean task, if not impossible. The suggestion also fails to take into account the numerous pending patent applications over COVID-19 vaccines that could create a chilling effect for potential manufacturers. The proposed amendments of the UK would also exclude other tools important for the manufacture of COVID-19 vaccines such as single use bio-bags, single use filters, micro fluid and nano fluid mixers for lipid nano particles etc., even as the world has seen a shortage of many of the tools needed for manufacturing due to the high concentration in the production of these tools. With the addition of the UK’s proposals (that have not been agreed to), the text in Footnote 2 is: “For the purpose of this Decision, it is understood that subject matter of a patent’ [includes][ means patented finished COVID-19 vaccine products, patented] ingredients and [patented] processes[for use in] [ necessary for] [in relation to] the manufacture of the COVID-19 vaccine”. Export waiver only for vaccines and not ingredients The UK has further proposed limiting the scope of the sole waiver in the negotiating text relating to Article 31(f) of the TRIPS Agreement. Paragraph 3(c) of the Decision proposes a waiver of Article 31(f). This is the only waiver in the text, very distant from the content of the original TRIPS Waiver proposal co-sponsored by 65 developing countries that seeks waivers of TRIPS obligations with respect to patents, trade secrets, copyright and industrial designs. Article 31(f) prescribes that any compulsory/government use license should be predominantly for the supply of the domestic market of the WTO Member authorizing such use. This means that a compulsory or government use license cannot be issued exclusively or predominantly for export purposes. Since this restriction affects the supply of health products to countries having no manufacturing capacity, the TRIPS Agreement was amended to add Article 31bis. However, Article 31bis imposes extremely cumbersome conditions, which makes the flexibility difficult to use. To date, there is only one instance of the use of Article 31bis. This is one of the important reasons for seeking the waiver of Article 31(f) for COVID-19. The DG’s text reads: “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, including through international or regional joint initiatives that aim to ensure the equitable access of eligible Members to the COVID-19 vaccine covered by the authorization”. The UK has proposed replacing “authorized use” with “COVID–19 vaccine produced under the authorization in accordance with the Decision“. Effectively, the scope of the Article 31(f) waiver would then only apply to COVID-19 vaccines, excluding application of the exportation waiver to the tools such as ingredients required to produce the vaccines, making the entire decision unworkable. An article in Nature Biotechnology dated 21 May 2021 revealed the complex intellectual property landscape behind mRNA-based COVID-19 vaccines, including patents on lipid nanoparticles, a critical ingredient for such vaccines. The UK’s proposal has been opposed by several developing countries participating in the text-based negotiations, but the UK has refused to withdraw its proposal. The UK’s position is supported by the EU, according to officials involved in the negotiations. Supply covers only export and import Another attempt by the UK to limit the scope of the Decision, is to seek deletion of the word ‘supply’ in Paragraph 1 of the negotiating text. The DG’s original text reads: “Notwithstanding the provision of patent rights under its domestic legislation, an [eligible] Member may limit the rights provided for under Article 28.1 of the TRIPS Agreement (hereafter ‘the Agreement’) by authorizing the use of the patented subject matter required for the production and supply of COVID 19 vaccines…” The UK proposal’s to remove the word ‘supply’ would thus narrow the Decision only to “production”, potentially creating confusion about the domestic use, export and import of COVID-19 vaccines produced under this Decision. In making the proposal, the UK argued that the scope of ‘supply’ was unclear for it could also refer to transportation and distribution of the vaccines. While there is nothing in the text that justifies the UK’s argument, its reasoning reveals its opposition to the cause of equitable access. Several officials involved in the negotiations privately confirmed that the EU, the UK and Switzerland are very much against the Decision having a scope that would enable access to tools that facilitate vaccination. Following the UK’s opposition to the word ‘supply’, another delegation proposed defining supply as: “For the purposes of this Decision “supply” refers to exportation and importation [of the subject matter of a patent as referred to in footnote 2]. With this definition, the Decision may not be used to supply domestic needs. Agreement has yet to be reached on the proposal to delete “supply” and its proposed definition. Restricting the scope of Article 39.3 (undisclosed information) Paragraph 4 of the DG’s text states: “Nothing in Article 39.3 of the Agreement shall prevent an eligible Member from taking measures necessary to enable the effectiveness of any authorization issued as per this Decision”. This text is provided to overcome the test data protection or data exclusivity barriers related to the regulatory approval of a pharmaceutical product. Notably, Article 39.3 does not require a government to provide protection of exclusive rights over data (data exclusivity) submitted by an originator pharmaceutical company for purposes of regulatory approval, which would prevent the entry of a generic version for a particular duration. Instead, Article 39.3 provides flexibility to countries to disclose tests and other data submitted for domestic marketing approval to protect the public or take measures against unfair commercial use. Though the Article 39.3 flexibility is independent of the patent status of a product, the DG’s text links the use of such flexibility to compulsory/non-voluntary license under the Decision. Switzerland proposed text that nullifies the existing flexibility under Article 39.3. The Swiss proposal reads: “Nothing in this paragraph shall be interpreted as allowing the disclosure of undisclosed information submitted by the originator to the respective authorities of an eligible Member in a marketing approval procedure”. Pre-shipment notification Paragraph 5 of the DG’s text states that: “For the 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. Footnote 5 is linked to Paragraph 5 and states: “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”. Several developing countries participating in the negotiations stressed the importance of simplified post facto notifications, citing burdensome notification requirements of Article 31bis for its non-use. In contrast, the UK proposed text in Paragraph 5 reads “but no later than… and before the shipment takes place”, requiring information regarding implementation of the Decision to be communicated within a specified time frame. Continued opposition from some countries, led to the UK then shifting its addition to the end of the footnote: “if possible before a/any shipment takes place”. Pre-shipment notification is not a requirement of Article 31 of TRIPS Agreement and hence is TRIPS-plus. For many developing countries involved in the negotiations, the UK and Switzerland are clearly intent on complicating the negotiations and erecting hurdles in the path towards equitable access. +
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