On 12 January, IFPMA attended an open session of the International Health Regulations (IHR) Review Committee, happening online and in Geneva. The purpose of the meeting was to provide updates on the Review Committee work on IHR amendments. Below is the oral statement we delivered.

Thank you for the opportunity to share our thoughts on the proposed amendments to the IHR. We thank the Review Committee for their commitment towards transparency and inclusion throughout this process and look forward to technically sound and evidence-based recommendations in the final report.

Given the short amount of time today, it would not be possible to share our comprehensive feedback, but we welcome those proposals that focus on strengthening governance, financing, and capacities at all levels – from local to global – to achieve the IHR objectives.

A concerted focus on capacity building efforts will set a sound foundation to strengthen prevention, preparedness for and response to health emergencies, and contribute towards the INB Pandemic Accord goal to enable more effective, efficient, and multi-stakeholder solutions to increase equitable access of vaccines, treatments, and diagnostics in pandemics.

IFPMA encourages the consistent coordination of the INB and IHR processes to ensure a non-duplicative, fit-for-purpose outcome for all. Furthermore, we would encourage that work not be duplicated on matters under discussion and within the purview of other multilateral organizations such as the WTO and WIPO.

Pathogen Sharing

We believe that the revision of IHR and the negotiations of INB Pandemic Accord are good opportunities to address the urgent issue of timely pathogen sharing.

Timely access to pathogen samples and sequences should be delinked from benefit sharing concept under the Nagoya Protocol. Nevertheless, a discussion which focuses on equitable access to medical counter measures should take place independently of pathogen sharing under treaty negotiations.

If we want to commit to a 100 Days Mission as part of G7 effort to address this issue, we cannot afford delays in pathogen sharing caused by the Nagoya Protocol. Tweet this

Nagoya Protocol concept is not a system that is compatible with the sharing of pathogens. That has been demonstrated in real life. The sharing of pathogens and their associated information must be fast, easy, and legally certain. The Nagoya Protocol is exactly the opposite, creating bureaucratic hurdles based on a transactional model that makes this increasingly difficult to achieve.

For example, since 2018, vaccine manufacturers have seen delays ranging from 3 weeks to 9 months before being able to access important influenza samples. Delays in accessing samples causes lives to be lost. Take SARS-CoV-2: a delay of just one month in accessing the virus samples could have led to an additional 400,000 lives lost.

If we want to commit to a 100 Days Mission as part of G7 effort to address this issue, we cannot afford delays in pathogen sharing caused by the Nagoya Protocol.

A heavy burden has been placed on industry to make available diagnostics, vaccines, and therapeutics within 100 days from the beginning of a future pandemic. Fulfilling this goal requires collaboration and access to pathogen samples and their related DSI very rapidly after an outbreak starts. Any delay has knock-on effects on R&D, manufacturing and, finally, availability and distribution of vaccines

The best way to ensure that critical virus samples and sequences are shared in a timely manner is to exclude them from the bilateral obligations of the CBD, Nagoya Protocol, and national legislation on the grounds of ensuring global public health and that any potential multilateral mechanisms do not hinder or delay access to pathogens, nor pose a barrier to innovation and development of medical countermeasures.

Intellectual Property

We looked at Member States’ IHR targeted amendments proposals with great interest and note that some made false presumptions that intellectual property is a barrier to access, without any evidence. This is simply not the case. Intellectual property incentives facilitate technology transfer, know-how sharing, and licensing and allow for further R&D, which is a necessary step in joint efforts to be better prepared for the next pandemic.

About IFPMA

IFPMA represents the innovative pharmaceutical industry at the international level, engaging in official relations with the United Nations and multilateral organizations. Our vision is to ensure that scientific progress translates into the next generation of medicines and vaccines that deliver a healthier future for people everywhere.

To achieve this, we act as a trusted partner, bringing our members' expertise to champion pharmaceutical innovation, drive policy that supports the research, development, and delivery of health technologies, and create sustainable solutions that advance global health.

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Media Contact

Grega Kumer g.kumer@ifpma.org