WHO: US pushes Big Pharma agenda in pandemic instrument talks

Vaccine

Geneva, 17 May (TWN) – The United States pushed for regulatory reliance and regulatory harmonisation in the recent negotiations of the pandemic instrument which advances the interest of pharmaceutical transnational corporations (TNC).

This took place during the resumed 9th session of the Intergovernmental Negotiating Body (INB) when Article 14 of the Draft Negotiating Text of the pandemic instrument draft text was negotiated. The meeting was from 29 April to 10 May.

Article 14 deals with regulatory strengthening. Apart from strengthening the pandemic-related products proposals this Article aims to create obligations on Parties with regard to the medicine regulatory system, going beyond the mandate of the pandemic instrument.

Article 14.3 (b) of the draft negotiating text states: “… publicly disclose information on national and, if applicable, regional processes for authorizing or approving the use of pandemic-related health products, and adopt regulatory reliance processes or other relevant regulatory pathways, as appropriate, for such pandemic- related health products that may be activated during a pandemic to increase efficiency, and shall update such information in a timely manner”.

Further, Article 14.5 states: “The Parties shall align and, where possible, harmonize technical and regulatory requirements and procedures, in accordance with applicable international standards, guidance and protocols, including those covering regulatory reliance and mutual recognition, and shall make publicly available relevant information, data and assessments concerning the quality, safety and efficacy of pandemic-related health products with other Parties”.

The US moved to alter Article 14 and the text negotiated within the Working Group on 7 May was based on a US-prepared text. That text contained the following proposals that push for obligations on regulatory reliance and harmonisation.

Regulatory Reliance

The rationale for regulatory reliance is to accelerate the regulatory approval of medical products relying on information submitted to a regulatory authority, including assessment reports by other regulatory authorities.

WHO’s Good reliance practices in the Regulation of medical products: high-level principles and Considerations defines the reliance as “The act whereby the regulatory authority in one jurisdiction takes into account and gives significant weight to assessments performed by another regulatory authority or trusted institution, or to any other authoritative information, in reaching its own decision. The relying authority remains independent, responsible and accountable for the decisions taken, even when it relies on the decisions, assessments and information of others”.

This is different from recognition. According to the WHO Guidelines, “Recognition may be seen as a special and more formalized approach to reliance, whereby one regulatory authority recognizes the decisions of another regulatory authority, system or institution, obviating additional regulatory assessment to reach its own decision.”

Thus, reliance does not always mean the automatic recognition of the regulatory decision of another regulatory authority.

The success of reliance requires access to information available from a regulatory authority to the other regulatory authority, which is relying on the decision of the former. The absence of access to the full information submitted by companies for obtaining marketing approval would incapacitate the regulatory authority following reliance.

Since pharmaceutical TNCs seek marketing approval primarily from the US and the European Union regulatory authorities, the developing country regulatory authorities would be following regulatory reliance.  Access to information is critical for the regulatory reliance. According to WHO Guidelines, “Lack of access to complete assessments of reference regulatory authorities can be a major barrier to effective reliance. Reference regulatory authorities should make their assessments and other regulatory information publicly available”.

During the resumed 9th INB session negotiations developing countries sought access to regulatory dossiers as a condition for agreeing to regulatory reliance. However, the US as the main proponent of the regulatory system strengthening agenda opposed this proposal and put the word “access to regulatory dossiers” within brackets (indicating disagreement).

Article 15.4 now reads:

“Each Party shall endeavour to, subject to applicable national and/or domestic law, adopt, where needed, regulatory reliance mechanisms in its national and, where appropriate, regional regulatory frameworks [for use during pandemic emergencies] [, subject to the availability of regulatory dossiers], [for pandemic- related health products] taking into account relevant guidelines.”

The US opposition emanates from its reluctance to undertake any obligations on sharing dossiers. The US Food and Drug Administration (FDA) in practice shares publicly non-available information with other regulatory agencies through a confidentiality commitment. Operationalising an effective and functional regulatory reliance depends on the availability of information including dossiers to developing country regulators.  Reliance in the absence of access to full information would undermine the capacity to rely on regulatory authorities and in the long run, would create dependency.

Further, in the absence of such information liability claims emanating from injuries due to the use of vaccines or therapeutics cannot be addressed effectively.

Regulatory Harmonisation

According to the US FDA regulatory harmonization “represents a process where regulatory authorities align technical requirements for the development and marketing of pharmaceutical products”.

WHO describes it as this: “Harmonization of technical requirements for medicines regulation, i.e., legislations, technical guidelines, procedures, etc., is a basis for successful collaboration in the area of medicines regulation. In implementing of the medicine’s regulation, it should be noted that this could not be effective if all major aspects of regulation are not addressed.”

The rationale for regulatory harmonisation is to avoid delay in marketing approval of medicines by harmonising various regulatory requirements including the information required for the regulatory approval.

However, such harmonisation also raises concerns about access to medicines because harmonisation is effectively upgrading the regulatory requirements to the level of standards set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which will lead to high compliance cost and impact the prices of the medicines. Often such ICH “high standards” do not add to safety, efficacy and quality but instead limits generic competition.

In January 2024 the US had proposed the following amendment to Article 14:  “Each Party shall adopt and implement, when practicable, consistent with national law and procedures, guidance and technical documents concerning medical products developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Medical Device Regulators Forum (IMDRF) or their succour organisations”.

Thus, the word harmonisation implies ICH and IMDRF standards.

The implications of adopting ICH standards on access to medicines are summarised by a WHO meeting of regulators way back in 2001 as follows: “The public health implications of the application of guidelines of greater technical complexity in developing countries may be far reaching. In many countries, essential drugs required for the prevention and treatment of locally endemic conditions are not supplied by the major multinationals, but by local industry or by generic manufacturers. If these suppliers are unable to meet what may be unsubstantiated quality standards, the adverse impact of withdrawal of these drugs on the health of the population might well be far more dramatic than that of any hypothetical risk posed by failing to achieve the ICH standards.”

The ICH management committee is dominated by developed country regulators and pharmaceutical TNC associations. Currently, the management committee (MC) consist of 13 Regulatory and Industry Members and 2 Standing Observers. According to ICH website: “To date, the ICH MC is composed of 13 Observers. The ICH MC has permanent representatives from the six Founding Members (EC, Europe; EFPIA; FDA, United States; JPMA; MHLW/PMDA, Japan; PhRMA), Standing Regulatory Members (Health Canada, Canada; Swissmedic, Switzerland) as well as Standing Observers (IFPMA; WHO). In addition, since June 2021 and as per the ICH Articles of Association, the following MC Elected Representatives have been nominated to join the MC and will serve until the next election in June 2024: ANVISA, Brazil; BIO; IGBA; MFDS, Republic of Korea and NMPA, China”.

(The ICH was founded by the regulatory authorities of the US, the EU and Japan together with three major pharmaceutical TNC associations. These 6 entities are permanent members while the others are rotated based on elections.)

The discussion on 9 May, based on developing countries like India and Malaysia, opposed the harmonisation agenda and put the term in the bracket. India proposed the deletion of the entire paragraph The paragraph now reads as follows:

[The Parties shall endeavour to, subject to applicable law:

[converge and/or align [and[/or harmonize, where appropriate,][, where possible, harmonize (DEL)] (DEL)] relevant technical and regulatory requirements, in accordance with applicable international standards and guidance; and (DEL)].

(DEL means delete.)

In 2014 developing countries successfully removed all references to ICH and harmonisation from a WHO resolution on regulatory system strengthening.

The harmonisation and reliance agenda has the potential to make Article 10 (sustainable and diversified production) and 11 (technology transfer) meaningless by pushing for high regulatory compliance that is essentially about deepening the monopoly of pharmaceutical TNCs. - Third World Network