II The pathogen sharing regimes

In responding to infection diseases, the need for ongoing surveillance, quick risk assessment, implementing control measures, development of vaccines and medicines and their timely distribution is obvious. The public health response to infectious disease relies on ongoing surveillance, timely risk assessment, implementation of public health control measures, and access to medical interventions, such as vaccines and medicines. For example, in case of influenza, access to circulating influenza viruses is necessary and monitoring their spread and responding to outbreaks has to be an ongoing exercise. Under the Global Influenza Surveillance and Response System (GISRS), a global network of laboratories analyses the samples of viruses, does risk assessment, assesses the pandemic potential of novel strains and suggests measures for risk management. The WHO co-ordinates this network, and for the effective functioning of such a network timely access to samples from different parts of the world is essential. Vaccines are produced and distributed based on the materials and information from the GISRS.

However, this system faced a crisis in 2007 when Indonesia refused to share virus samples and asserted that it had national sovereignty over them and raised the issue of fair and equitable benefit sharing for countries that provided samples, but were not assured of anything, including vaccines, in return. After protracted negotiations, in 2011 the World Health Assembly adopted a resolution paving the way for establishing the Pandemic Influenza Preparedness Framework (PIPF or Framework) for enhancing influenza preparedness and strengthening the GISRS, “with the objective of a fair, transparent, equitable, efficient, and effective system for, on an equal footing: (i) the sharing of H5N1 and other influenza viruses with human pandemic potential; and (ii) access to vaccines and sharing of other benefits, such as diagnostics and antivirals.”

The PIPF was negotiated and adopted under the auspices of WHO. Yet, it is not a binding framework. Its scope is limited to influenza viruses with pandemic potential. Similarly, seasonal influenza viruses and the other non-influenza pathogen are not covered by GISRS. Article 4.2 explicitly excludes biological substances that may be contained in clinical specimens shared under the framework. This means that even if they are accidentally transmitted they are beyond the purview of the agreement.

The PIPF recognises the country sovereignty over biological resources and uses two Standard Material Transfer Agreements (SMTAs) to govern the movement of samples in and out of the WHO surveillance system. SMTA1 governs the transfer of samples within GISRS. SMTA2 governs the transfer of samples to third parties outside GISRS such as researchers and vaccine manufacturers.

Using SMTA1 is relatively easy and the movement of samples is confined to National Influenza Centres, WHO laboratories and WHO. SMTA2 has to be signed by the WHO Director General and the recipient prior to the transfer.

There are three categories of recipients: (1) influenza vaccine manufacturers and antiviral medicine manufacturers (that must choose two of the six pre-defined benefit sharing options); (2) manufacturers of other products relevant in pandemic influenza preparedness and response (that must choose one of the six pre-defined benefit sharing options); (3) other recipients, who are not in one of the above categories (and must consider contributing to the PIPF benefit sharing mechanism).

The scope of the benefit sharing obligations has to be negotiated between WHO and the recipient, taking into account the nature and capacities of the recipient. Thus, negotiations and obligations on benefit sharing are inevitable when SMTA2 is used. Usage of SMTA1 and SMTA2 implies that all parties have agreements with WHO but not with each other. This applies to benefit sharing as well. For example, if the WHO has negotiated a benefit sharing agreement through SMTA2 and a country is to benefit from that, then the country has the right to the agreed benefits vis-à-vis, and, not with the other party to SMTA2. Use of SMTA2 leaves open the issue of intellectual property rights and this can be negotiated between WHO and the recipient but there is no explicit prohibition or bar on getting such rights by the recipient through the use of the material. Thus the recipient can get patent protection for vaccine developed through the use of the shared material but will have to fulfil the benefit-sharing obligations. This ensures that access by those not covered by GISRS is not free and comes with some benefit-sharing obligations.

It can be argued that the Framework establishes a specialised ABS framework exclusively for influenza viruses with pandemic potential: a multilateral system is therefore combined with a bilateral one. Given the objectives of the Framework, its recognition of country’s sovereignty over the specific genetic resource and its emphasis on benefit sharing linked with access and use of SMTAs to create obligations in benefit sharing, it can be argued that said Framework is fully consistent with the letter and spirit of the Protocol. Hence it can be considered as a specialised instrument in the context of Article 4(4) of the Nagoya Protocol.

Under the sharing system in PIPF, the industry has to pay for 50% of the annual operating costs of GISRS besides providing partnership contributions which will be used by WHO for assisting developing countries in their influenza surveillance and in estimation of burden of disease. Companies can donate vaccines/anti-virals during a pandemic or offer discounts in price.

But there are contentious issues with the Framework. For example, breach of SMTA provisions by laboratories in GISRS can result in sanctions such as suspension or revocation of laboratories’ designation by WHO. When a non-GISRS institution transfers materials to another non-GISRS institution there is no provision for any penalty or sanction.

Besides sharing influenza viruses there is also a global system for sharing of data run as a non-profit initiative. This is called GISAID (Global Initiative on Sharing of All Influenza Data), and provides the publicly accessible EpiFlu™ database. This is used extensively by researchers. Access to data is free, subject to proper identification. The access is subject to the conditions that those who access should acknowledge the contributions of data providers and their rights including intellectual property rights. Submission of data does not deprive the submitting party of any rights over data deposited by them.

III The Nagoya Protocol

The Nagoya Protocol was negotiated under the Convention on Biological Diversity (CBD) and came into effect in October 2014. It governs access to genetic resources, including pathogens in countries that are parties to the Protocol for research and commercial purposes. Based on the principle of fair and equitable sharing of benefits, parties can impose restrictions in using the genetic resources to which access has been provided under the ABS regulations. The access and benefit sharing has to be negotiated and, invoking national sovereignty over genetic resources, a country can refuse to share pathogens or provide access to them.

The Nagoya Protocol takes into account public health concerns through Article 8(b), which requires parties to pay due regard to “present or imminent emergencies that threaten or damage human, animal or plant health, as determined nationally or internationally” when implementing regulations on access and benefit sharing. During the negotiations on the Protocol, the issue whether genetic resources with pathogenic properties should be excluded from the scope of the Protocol became a contentious one, with developed nations arguing for their explicit inclusion while developing nations favored their explicit inclusion. Finally, instead of an explicit inclusion or exclusion, it was decided that such genetic resources would be covered by general provisions under Article 3 and 4 and specifically addressed in Article 8(b). The Preamble reflects the Framework and the importance of ensuring access to pathogens for public health purposes. It is obvious from Preamble 16 of the Protocol that pathogens are within its scope. Article 8(b) does not create any special benefit sharing regime for pathogens. Given the objectives of the Protocol, benefit sharing from providing access to pathogens cannot be excluded in interpreting and implementing the Protocol.

Within the framework of the Protocol the following are the four options available to parties. The first option is that a party can develop a national regulatory framework for pathogens as genetic resources and cover this under an ABS framework. This includes the possibility for developing an exclusive ABS regime for pathogens, given the importance of access to them and sharing such pathogens for public health purposes. The second option is that a party can enter into an agreement under the Framework and commit to adhere to its norms and undertake to fulfil obligations coupled with benefit sharing from the Framework. The third option is that a party can develop an ABS regime on its own for pathogens irrespective of PIPF. In fact, parties are not bound to take into account the Framework when deciding their policy or regulatory regime for ABS. The fourth option is that a party can designate PIPF as the ABS framework for influenza viruses covered by it and thereby exempt them from national regulations. Under such a circumstance the contracts will be between WHO and third parties and the party can be a beneficiary of benefit sharing.

The Protocol mandates the application of the principle of Prior Informed Consent (PIC) and enables countries to develop a coherent ABS regime consistent with the Convention on Biodiversity (CBD) and the Protocol. However, among countries there is no uniformity in interpreting and implementing the principles and provisions. Moreover consideration-related issues and elaborated procedures in accessing and entering into agreements for ABS have complicated matters in access to and use of genetic resources under the Protocol. This is the major criticism in applying the Protocol for providing access to genetic resources. The principle of equitable benefit sharing is a noble idea but translating that into practice has created problems in gaining access to the genetic resources.

Article 4 of the Protocol specifies that the Protocol shall not affect the rights and obligations of any party deriving from any existing international agreement and it is not intended to create any hierarchy among international instruments. Further, it states that the Protocol shall be implemented in a mutually supportive manner with other international instruments. The most important aspect of Article 4 is that it clarifies that, where a specialised international access and benefit-sharing instrument applies, this Protocol is not applicable. For example, the Protocol is not applicable for collections covered under the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA).

Yet, whether the Framework is a specialised international access and benefit sharing is a debatable issue. One view as pointed out earlier is that it could be considered so. However, the Framework is nothing but a mechanism that regulates access and benefit sharing among two sets of players and the providers of the samples. The contractual obligations are vis-à-vis the WHO and the beneficiaries/recipients and the donors/providers do not enter into agreements with each other. In other words, the parties involved are not exclusively the nations which are parties to the Protocol. Moreover, although the WHO Assembly approved and adopted the resolution for establishing the Framework, that per se does not make the latter an international instrument that can meet the requirements of Article 4.4.

As Article 4.4 refers to a specialised international ABS instrument that will be applied as a substitute for the Protocol, it is obvious that such an instrument has to be a Treaty or a Protocol negotiated under a Convention or Treaty with binding effect. It should also be an ABS instrument dedicated for a specific objective. The WHO resolution and the PIPF do not fulfil these criteria.Footnote ³

If parties to the Protocol agree that the Framework be considered as a specialised international access and benefit sharing agreement under Article 4.4, then the issue would be settled. The other option could be for the parties to consider the Framework as a specialised ABS instrument, if some changes are made in the Framework and it is made a binding one. In such a case the Framework could be renegotiated and be converted into a Protocol under the CBD or as a supplementary protocol to the Nagoya Protocol. The possibility of this is remote because then the current Framework would have to be totally redesigned. This is possible only after protracted negotiations. As the Framework is working well and the concerns are expressed more on account of delays in accessing due to the implementation of the Protocol than on account of functioning of the Framework, parties may not be interested in replacing the Framework.

IV The way forward

After reviewing four models for reconciling open access and benefit sharing, academic works by Lawson and Rourke suggest that while none of them is a perfect solution, open access and benefit sharing can be partially reconciled through them.Footnote ⁴ While a perfect solution may evolve over a period, perhaps through trial and error, other options should be evaluated. Given the concern over delays in access to virus samples on account of implementation of the Protocol, there are few options that can be considered to reduce or eliminate the delay in sharing and accessing the virus samples. Some of the options have been discussed in the study by the WHO Secretariat.Footnote ⁵

One of the options suggested is to consider the Framework as an Article 4.4 specialised international access and benefit-sharing instrument. This would result in exempting influenza viruses with pandemic potential from the requirements of a case-by-case Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT), as envisaged in the Protocol. This will result in more certainty about the legal status of the viruses and will strengthen the PIPF. Given the contentious issues with the Framework as discussed above, the downside is that not all countries may agree to this. Instead they might prefer the Framework to address the contentious issues and ensure that there is no access or sharing without benefit sharing. Another issue that might worry countries is that choosing this option would result in reduced control over these genetic resources and could become a ‘wrong’ precedent for the future.

Another suggestion has been to invoke Article 8(b) for rapid access to pathogens that are threats to public health or in a likely emergency situation without compromising on equitable benefit sharing. In my view this is a workable solution but the question is how many countries would be willing to invoke Article 8(b) for influenza viruses. Countries may think that Article 8(b) could be used as a Trojan horse if, once such a demand has been conceded, it will cause the weakening of their sovereign right and the demand for ABS under the Protocol. Creating synergies between the Protocol and the Framework is one of the suggestions made as a response to the Survey conducted by the WHO. This can be explored and action points for creating synergies could be developed.

In my view, a better approach would be to develop a common pool of viruses shared under the Framework and create a Multi-Lateral System (MLS) similar to the one created under ITPGRFA, with access and benefit sharing and the use of MTAs to regulate transfer and use of materials. Yet, to implement this idea, the Framework has to be revised and a mechanism for creating and governing a common pool has to be created. This will not affect the implementation of the Protocol nor will it affect the rights of the Parties to the Protocol. The advantage of this system is that it creates a pool that can be considered as an access linked to a benefit sharing mechanism. Such a mechanism can have different rules for different types of uses and users with contractual obligations enforceable through MTAs. For example, the benefit sharing-mechanism for academic research could be a simpler one, while for commercial use and use for development of vaccines, the terms may include royalties, better access to vaccines and obligations to donate or supply vaccines at a cheaper price for developing countries and least developing countries. In fact, the current ABS mechanism under the Framework can be tweaked to develop a new one. Such a pool and GISAID could complement each other.

According to Wilke,Footnote ⁶ the Framework can better be considered more as a common pool than as a bilateral system. She points out that while the PIPF system differs from the classic concept of common pools, it shares the main features of a common pool. In particular, she notes that the concept of common pool is suitable to analyse and assess the Framework. I agree with such a view. Yet, as of now the resources available under the Framework have not been consolidated to create a common pool. In fact, the Framework functions more as a bilateral mechanism than a fully-fledged system that maintains a common pool. Making that a fully functional common pool is a challenge, but one that can be met through modifications in the Framework and its functioning. When it becomes a fully functional common pool, incentives can be provided to share and access the available resources, and access can be linked to incentives to contribute and share. Parties to the Protocol can be encouraged to share and contribute virus samples through a benefit-sharing mechanism that is more attractive than the current one.

Having said that, I should point out that creating or developing a common pool is not a simple task. The current Framework envisages bilateral contracts and links benefit0sharing mechanisms. It does not envisage a shareable common pool that can be made available to all stakeholders including parties to the Protocol and vaccine manufacturers. Thus, transforming the Framework to enable the creation of a pool is a significant challenge.

Hence, I would suggest that the options expressed in the WHO study should be examined further and that the WHO should welcome suggestions on mechanisms to enhance better access to virus samples without contravening the Protocol or the Framework. This organisation should then develop further such suggestions as workable propositions and place them before its Member States for further discussion and action.