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TWN
Info Service on Intellectual Property Issues (Oct21/01) A European Commission “reflection paper” supports the argument that its proposal for a pandemic treaty aims to secure the European Union’s health security interests using hard law in a selective manner, and then leave the requirements of public health response coordination and cooperation to non-binding soft law mechanisms. It means there is little political momentum within the EU to strengthen the legal duty to cooperate under the existing International Health Regulations or to enhance timely equitable access to health care products with binding legal force. Kuala Lumpur, 3 October (TWN) – The European Commission (EC) envisages the proposed pandemic treaty as a framework convention with binding and non-binding provisions. In a “reflection paper” dated 26 August 2021 the EC spells out its vision on this treaty. The paper proposes an International Agreement on Pandemic Preparedness and Response which it refers to as the Pandemic Treaty (PA), asserting that it would fall within the scope of Article 2.1(a) of the Vienna Convention on the Law of the Treaties. Article 2.1 (a) of the Vienna Convention defines a “treaty” as follows: “an international agreement concluded between States in written form and governed by international law, whether embodied in a single instrument or in two or more related instruments and whatever its designation”. The discourse so far has been that such a treaty, if its need is agreed upon, would be an instrument under Article 19 of the World Health Organization’s Constitution. However, according to the paper it could be adopted under Article 19 of the WHO Constitution only if the instrument can make rules and regulations to combat pandemic that are outside the competence of the WHO. The paper hints at the difficulty in doing so by citing the regulation of trade in wild animals as an example, which falls within the scope of the One Health approach but this “could be deemed beyond the remit of WHO”. The EC’s paper further states that the PA should contain both hard law (binding) and soft law (non-binding) with an objective of designing effective solutions to the varied issues associated with pandemic response. It requires negotiating states to “resort to setting out “soft law” standards accompanied by compliance incentives, “best efforts” commitments backed by a general good faith obligation, as well as “political” commitments subject to reputational considerations”, wherever necessary. Additionally, the paper proposes a flexible and open model of participation by allowing regional economic organisations to become parties to PA or to the specialised protocols to be negotiated under it. In other words, it means the EC could be a party of PA in addition to WHO Member States. As part of “flexible” participation all UN Members may be allowed to participate in the negotiations on protocols under PA, even if they are not party to the PA. The PA would also allow for the participation and contributions of non-governmental stakeholders. However, it is not clear whether the term non-governmental stakeholders include the participation of the private sector. The paper further promises a transition period to low and lower middle income countries for the implementation of the treaty. The paper states that the PA aims to prompt compliance with the International Health Regulations (IHR) without amending them. It states that the PA should “set out compatible, complementary, clarifying provisions, including, when necessary, compliance incentives, and enhanced obligations that would be enforceable only among PA Parties.” However, the paper recognizes that “in time the usefulness of such enhanced provisions could become widely accepted and lead to amendments and/or agreed interpretations of the IHR, as appropriate”. The reason for this approach is quite obvious, as amendment of the IHR as the preferred way to enhance pandemic response would undermine the need for a new treaty as advocated by the European Union. Moreover, a move to amend the IHR would bring to light the need for better accommodation of the special requirements of developing countries. The
proposed PA has the following 7 sections; however, the substantive
obligations are aimed at the first three areas: (See below for details of each section.) It is noteworthy that the reflection paper is silent on the Convention on Biological Diversity and its Nagoya Protocol on the regulation of access and benefit sharing in the context of sharing of samples and pathogens (including digital sequence information). The paper also proposes to convert mechanisms like the WHO’s Access to COVID-19 Tools (ACT) Accelerator, which failed to address the current inequity in access to medical products, as a mechanism for the procurement and delivery of medical products. There is no indication of sharing of technology to produce required medical products. Further, it is not clear whether the provisions on the R&D and production of medical products would be binding or a soft law to be implemented on a voluntary basis. The ideas as reflected now in the paper seek to increase trade liberalization in the guise of health emergency preparedness and response measures. The paper also envisages to establish a Conference of Parties as an institutional framework for governing the PA. The future rule-making sections show that the proposed PA will be designed as a framework convention with protocols and WHO would host the Secretariat. A framework convention often lists the broad legal principles, and details of its implementation is done through protocols. It is not necessary that all parties to a framework convention will necessarily join any protocol that is subsequently negotiated. Thus, a framework convention could bring uneven legal obligations in the area of health emergencies or pandemics, and this would compromise the effectiveness of legal norms on the ground. Further, finalisation of each protocol can take years and delay the effective implementation of the framework convention. The paper dismisses amendment of the IHR as the way forward on the ground that this “is likely to require a protracted negotiation effort” yet experiences of framework convention development also have a track record of multi-year negotiations. Finally, the paper envisages assessed contributions to support the Secretariat of the proposed framework convention. The paper recognises the need for huge investment to support the PA implementation but does not provide any concrete suggestion for the needed resource mobilisation. The two areas mentioned in the paper for support as part of PA implementation are:
In short, the EC’s paper supports the argument that the EC is using the pandemic treaty as an instrument for promoting the strategic autonomy and positioning of the EU in international health governance. It aims to secure the EU’s health security interests using hard law in a selective manner, and then leave the requirements of public health response coordination and cooperation to the soft law mechanisms. It means there is little political momentum within the EU to strengthen the legal duty to cooperate under the existing IHR or to enhance timely equitable access to health care products with binding legal force. Note: The proposed PA has the following 7 sections; however, the substantive obligations are aimed at the first three areas: 1.
Preventing and controlling Each of these 3 aspects is further divided into sub-areas each containing multiple sub-elements. They are paraphrased as follows: “1.
Preventing and controlling pandemic threats ·
b) Preventing inadvertent laboratory release of pathogens through: ·
c) Preventing epidemics due to pathogens resistant to antimicrobial agents (AMR) through: ·
2. Detecting and reporting pandemic threats ·
3.
Preparing for and responding to pandemic threats ·
b) Coordination of emergency response measures ·
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