WIPO Standing Committee on Patents: Statement on Patents and Health

On 16 October 2024 in Geneva, IFPMA delivered a statement at the 36th meeting of WIPO's Standing Committee on Patents: Patents and Health.

The International Federation of Pharmaceutical Manufactures and Associations (IFPMA) represents the leading research-based biopharmaceutical companies as well as national and regional industry associations around the world. We appreciate the opportunity to address the agenda item of patents and health.

Intellectual Property (IP) plays a pivotal role in the development of healthcare products and services. The IP system was the driving force behind the innovations that helped us address the COVID-19 pandemic in an unprecedented manner, and it continues to lay the foundation for future healthcare solutions. During the pandemic, the biopharmaceutical industry entered into more than 450 voluntary partnerships around the world to support an unprecedented scale-up in manufacturing. This allowed for the delivery of nearly 16 billion doses of COVID-19 vaccines. The pandemic also highlighted several challenges, such as the urgent need to strengthen supply chains and regulatory frameworks, and to address trade restrictions. IP was not one of them.

Yet, we continue to hear calls to weaken IP rights and arguments suggesting they are potential barriers to R&D, public-private collaborations or access to healthcare.

With respect to the document SCP/36.6, there is little recognition of experiences from industry, academia, and governments to tackling the COVID-19 pandemic and other voluntary collaborations that were enabled by IP.

When the Secretariat was requested to update the report based on available literature and news reports, we believed this would be an opportunity to highlight the successful voluntary partnerships of our member companies with both governmental and non-governmental organizations as far-ranging as the World Health Organization (WHO); the Coalition for Epidemic Preparedness Innovations (CEPI), GAVI, the Vaccine Alliance, the Medicines Patent Pool (MPP), and UNICEF, as well as the development of novel treatments and vaccines. We believe this opportunity was missed.

The updated report has also removed key sections of the earlier report, which included details of our members companies' commitment to not file or assert patents in low-income or least-developed countries; and to use differential pricing to address healthcare inequities. Notably, the report also fails to acknowledge previous literature from WIPO, including the WIPO annual report from 2022, that estimated the social benefit of COVID Vaccines at USD 70.5 trillion, exceeding the private benefit by a factor of 887, showcasing the enormous value and positive impact that innovation, supported by the IP system, brings to global health and the economy.

IFPMA remains committed to working closely with WIPO, member states and other stakeholders to promote sustainable policies that encourage pharmaceutical innovation.

We appreciate the opportunity to make this statement on behalf of IFPMA. This is a crucial year for advancing action on AMR. Eight years after the first ever AMR high level meeting in 2016, the second one concluded in New York last month. We welcome the ambitious agenda set forth by the UN Member States and stand ready to work with all partners in advancing progress. We further welcome the regional leadership in the form of Saudi Arabia hosting the Fourth Global High-level Ministerial Conference on AMR under the theme of "From Declaration to Implementation" next month, as well as the WISH Summit here in Qatar. We look forward to contributing to both.

We appreciate the focus placed by WHO EMRO on accelerating the response to AMR in the region and underscoring the importance of a sustainable AMR response both in achieving UHC and health security.

We are broadly supportive of the three core strategic priorities and the cross-cutting strategic priority on effective governance and financing, which recognizes the important role of all stakeholders, including the private sector.

While we have seen progress in the fight against AMR over the years, important gaps remain, which the report also recognizes. AMR is already associated with millions of deaths globally and is projected to result in significant economic loss as resistance increases, unless action is taken.

Focus should be given to solutions that can address the antibiotic pipeline and access challenges, which needs to include working with industry. It is critical we recognize the unsustainable economics of antibiotic research and development (R&D) as a core driver of the deteriorating clinical pipeline, which, together with diverse barriers to access, contributes to uneven availability of effective antibiotics.

Well-established and tested solutions are at our disposal in the form of pull incentives to bring about renewed investment and innovation. Recent analysis published by IFPMA suggests that without effective incentives and additional investment the pipeline will continue to decline, and experts and researchers continue to move to more attractive areas of medical R&D - an estimated 50% drop in antibiotic R&D workforce between 1995 and 2020. But, if effective pull incentives are put into place, we could see twice as many antibiotic approvals over the next decade and three times as many projects in clinical development.

However, innovation alone is not enough. In alignment with good stewardship, access to both new and existing antibiotics is key. Improving sustainable access to antibiotics will require a broad set of measures, tailored to the context of each country or region.

Finally, we welcome the inclusion of vaccines in the report and the need to expand immunization programs. Vaccines are some of the most powerful tools for preventing infections and thereby address the root causes of AMR, including by reducing antibiotic consumption.

The innovative pharmaceutical industry remains committed to playing its part and working with stakeholders in accelerating action on AMR.

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