Access to Diagnostics, Vaccines and Treatments Presented by: Professor Duncan Matthews Date: Tuesday 16th June 2020 Not A Repeat Of TRIPS And Access To Medicine - Two diametrically opposed arguments in the current debate: • 1. Companies should give up their IP and consider this a public good • 2. IP is not a barrier to access and, without it, companies will not invest and innovate - The Covid-19 response is not just a repeat play of the access to medicines campaign from 20 years ago, when the focus was on TRIPS flexibilities (compulsory licensing, Doha Declaration) Public Health Imperatives In The Covid-19 Respons - The overriding public health objective is to test, treat, prevent: • Diagnostic kits (antibody, molecular and antigen tests) • Repurposing treatments (Remdesivir, KALETRA) • There is unlikely be one single effective vaccine response (who will manufacture and who will be vaccinated?) - Patents, regulatory data, know-how, trade secrets, designs, etc., all come into play Initial Public Policy Responses - Extending scope of compulsory licensing legislation (on all IP not just patents, also making them easier to issue) - Compulsory license on KALETRA (Israel/ABBVIE) - The role of regulatory agencies: • FDA's new policy to expediate approval of diagnostics • FDA emergency use authorization for Remdesivir • EMA compassionate use recommendations for Remdesivir Initiatives For Vaccine Development - Oxford University/AstraZeneca (ownership of IP/licensing) - Imperial College (ownership of IP/social contract model) - Who owns the IP and what are the licensing terms? - Gilead/Remdesivir voluntary licenses (but excluding many countries, including in Latin America) - Lack of transparency in licensing terms World Health Assembly Covid-19 Response Resolution - US disassociates from references to human rights and TRIPS flexibilities - Key features of WHO Technology Pool (voluntary and all IP not just patents) Offshoring Of Supply Chains - Trend for offshore pharmaceutical manufacturing, esp. APIs (cheaper labour costs, lower environmental standards) - Onshoring of pharmaceutical manufacturing of APIs - Reducing exposure to risks associated with global supply chains Takeaway Points - Companies working together in new and unprecedented ways in Covid-19 response - Covid-19 response requires a range of public policy responses (compulsory licenses, regulatory agencies, PPPs) Emerging Issues And Discernible Trends - Not just an issue of TRIPS flexibilities and access to medicines - Lack of transparency in licensing agreements leads to uncertainties about who owns IP and how it is shared - this is likely to hinder public scrutiny and debate (if there are restrictive practices, competition law may come into play) - Supply chain issues: enlightened interdependence or a new era of pharmaceutical nationalism? - The Covid-19 pandemic raises complex problems that require coordinated responses, and IP policy is part of that bigger picture