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Biotechnology Innovation Organization (BIO)

• BIO is the world’s largest trade association representing biotechnology

companies, academic institutions, state biotechnology centers, and related

organizations across the United States and in more than 30 other nations.

• BIO Members are involved in the research and development of innovative

healthcare, agricultural, industrial, and environmental biotechnology products.

International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

• IFPMA represents national pharmaceutical associations and research-based

pharmaceutical companies from across the globe. Based in Geneva,

Switzerland, IFPMA has official relations with the United Nations and WHO, and

it contributes industry expertise to help the global health community find

sustainable solutions that improve global health.

About BIO & IFPMA

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1. BIO and IFPMA welcome the opportunity to provide industry perspective with respect to the potential implications of rapid access to pathogens within the Convention on Biological Diversity (CBD) and the Nagoya Protocol (NP).

2. BIO and IFPMA support the general objectives of the CBD and NP.

3. Approaches to sharing of pathogen samples and GSD must promote rapid, timely, and systematic access for risk assessment and product development.

4. Placing restrictions on access and use would delay the sharing of samples and information within industry and the scientific community and erect systematic barriers to access by public and private researchers alike.

5. BIO and IFPMA are concerned that the way the NP is being implemented will have adverse effects on public health-related R&D, adding to the cost and time taken to bring drugs and vaccines to market and potentially diverting research away from areas of public health need.

6. CBD and NP concepts are concerning in the human pathogen context as pathogens transfer widely and rapidly between humans living in different countries.

General Points

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• To develop vaccine candidates, assays and other materials

• To test vaccines, therapeutics and diagnostics during development and clinical trials

• To identify potential targets for therapeutics, vaccines, and diagnostics development

• To diagnose patients and identify pathogens from biomedical samples

• Sequencing of pathogen genomes, together with date, location, clinical manifestation and other relevant data about sample origins, can contribute to describing nearly every aspect of transmission dynamics, including local transmission and global spread

• Environmental samples to assess what species are present

• Organisms to infer their evolutionary relationships

• Molecular biology laboratory work to verify results

Use of Pathogen Information in Biotechnology

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• The development of public health emergency medical countermeasures is

done through government / industry partnership due to the unique

development risk, need for rapid and coordinated requirements,

recommendations and dispersal complexities.

• Most of these infectious disease products have limited or no commercial

market.– Medical countermeasures (MCMs) for emerging, pandemic

potential threats, such as pandemic influenza rely on government

procurement and stockpiling.

• Assays and other building blocks for products are often made by

government agencies such as CDC, NIH DoD and then shared broadly to

facilitate product development.

Role of Industry in Preparedness and Emergency Response

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• Government partners such as the US Biomedical Advanced Research and

Development Authority (BARDA) and the Department of Defense partner with

industry to determine the best vaccines, treatments and diagnostics and

capabilities to help improve our ability to respond.

• Partners like the Coalition for Epidemic Preparedness Innovations (CEPI) help

de-risk the research and development of vaccines for pathogens of pandemic

potential.

• These organizations are supporting new capabilities that can speed

development, such as platform technologies, which can have multiple purposes.

• These investments are important for responding to target pathogens beyond

Ebola and Zika – Nipah, Lassa, other emerging pathogens and Disease X.

Role of Industry in Preparedness and Emergency Response

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• Industry is more cautious about developing these types of products now.

• Industry often does early clinical work to test their capabilities with new or

emerging pathogens but would not pursue these products as fully commercially

viable products given the uncertainty.

• Emergency response products would mainly be held as stockpiles with

governments, the WHO, GAVI or others until they are needed.

• Companies generally share in the cost of development with non-industry

partners. The decisions related to access and target populations during an

outbreak are not made by industry but by WHO, SAGE, GAVI, governments and

the broader stakeholder community.

Role of Industry in Preparedness and Emergency Response

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• Sharing of information in the public domain is foundational for the advancement of science in innovation around the world. Effective and efficient research and development is critical to achieving the objectives of the CBD and the NP, which include sustainable use of genetic resources.

• Many drug and vaccine development processes now utilize GSD exclusively without the need for biological material. Strategically Governemnt and prominent NGOs have been strongly supportive of this transition as a way to increase the speed and potentially lower the cost of vaccine and drug development.

• Identifying and applying ABS obligations is already complex. Complexity is compounded in biotech R&D where in principle multiple genetic resources from different sources are used for the development of one commercial product. Thousands of sequences may be used to in the development of one product.

• Would likely result in a dramatic reduction in information being made available in public databanks as access to GSD shifts from an open, multilateral approach to a closed, bilateral one.

Impact of Inclusion of Pandemic Pathogen Information

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Further aggravate the public health concerns associated with implementation of the CBD/NP

• BIO and IFPMA are already concerned that the way the NP is being implemented will have adverse effects on public health-related R&D, adding to the cost and time taken to bring drugs and vaccines to market and potentially diverting research away from areas of public health need.

• EU regulation mandates impractical due diligence obligations that must be fulfilled within three months of starting research based on pathogens causing a ‘present or imminent public health emergency of international concern or a serious cross border threat to public health’ or else the research must stop. The inclusion of GSD within the scope of CBD would further aggravate these challenges.

Impact of Inclusion of Pathogen Information