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Public health implications of the implementation of the Nagoya Protocol

Public health implications of the implementation of the Nagoya Protocol

The implementation of the principle of Access and Benefit Sharing, as stipulated under the Nagoya Protocol, has given rise to unexpected consequences for public health.

National access and benefit sharing measures need to take into account the potential impacts on public health.

The Biopharmaceutical industry is supportive of the objectives of the Convention on Biological Diversity (CBD), however, timely access to pathogens with pandemic and epidemic potential must be ensured to keep humanity safe.

Article 8(b) of the Nagoya Protocol indicates that parties must ‘pay due regard’ to public health emergency situations – this provision must be relied upon to ensure that humanity can respond in a timely manner.

Without access to pathogen samples and their related sequence information, critical medical countermeasures such as vaccines, diagnostics and therapeutics cannot be developed.

The Nagoya Protocol (NP) on Access and Benefit Sharing (ABS) is a legally-binding, supplementary international agreement to the Convention on Biological Diversity (CBD). Its objective is the fair and equitable sharing of benefits arising from the utilisation of genetic resources for the conservation and sustainable use of biodiversity.

Under the terms of the NP, genetic resources may be accessed subject to the Prior Informed Consent (PIC) of the country of origin, and once Mutually Agreed Terms (MAT) have been reached that include the “fair and equitable” sharing of the benefits arising from the utilisation of the concerned genetic resource. Those PICs and MATs are to be dealt with bilaterally (between user and provider) for each genetic resource.

The inclusion of pathogens (as a genetic resource) under the NP was not directly addressed in the final text. It was left to each Party to “pay due regard” to potential public health risks when implementing legislation. This has led to increasing confusion and lack of alignment surrounding the inclusion of pathogens in national ABS legislation that in turn has led to delays and disruption in the comprehensive sharing of pathogen samples and related genetic resource sequence data (GRSD). Those are essential components to equip manufacturers to produce the necessary diagnostics, vaccines and other treatments that contribute to a rapid response to epidemic and pandemic situations.

Current discussions at the CBD are considering the inclusion of GRSD under the scope of the NP, risking further jeopardising epidemic and pandemic preparedness and response.

IFPMA supports the work of the ICC in discussions related to access and benefits sharing. We do not support the inclusion of so called ‘digital sequence information’ under the NP as this would create significant barriers to scientific progress and would hinder the ability of humanity to rapidly respond to public health emergencies.

 

Influenza vaccine production is especially affected by delays in pathogen sharing.

Influenza vaccine development is on a strict 6-month schedule, a delay of a few weeks or more could potentially mean that vaccines are not available in time to mitigate the effects of circulating influenza strains.

Delays in pathogen sample sharing have already occurred for Ebola, Zika and Influenza – these can have irreversible knock-on effects for public health.

6-9 months

of delay in accessing influenza samples

3,500,000 virus samples tested

through GISRS

20 viruses selected

for candidate vaccine viruses

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