Accumulus Synergy’s Post

"Preparing for the next pandemic." Halabi and O'Hara have published a helpful article regarding the coordination global regulatory capacity in The New England Journal of Medicine with the following three points: (1) "the WHO should not only provide technical benchmarking tools for regulatory assessment, but also undertake focused planning after national regulatory systems have achieved advanced levels of maturity.” (2) "regional and multilateral development banks could agree that approval of a diagnostic, therapeutic, or vaccine by a WHO-listed authority with a given certification (e.g., maturity level 4) would be sufficient for them to extend loans for procuring that product.” (3) “as negotiators finalize a draft global pandemic agreement, provisions addressing regulatory strengthening could focus not only on national strengthening, but also on a coordinated and multilateral approach to leveraging regulatory capacity as it emerges.” https://lnkd.in/gZBtJHyF

Delighted to announce my participation in a crucial roundtable discussion hosted by the World Health Organization, Unitaid, USAID, FIND, and O'Neill Institute for National and Global Health Law during the International Monetary Fund/The World Bank Spring Meetings: “Financing to spur and sustain regional manufacturing of medicines and diagnostics in LMICs.” Recent global events have cast a spotlight on the vulnerabilities in our health systems, particularly the inequities in access to essential health products. By enhancing production capabilities in low- and middle-income countries, not only can we work towards bridging this divide, but we can also strengthen the resilience of health systems globally. This essential conversation will delve into the strategic financing and partnerships necessary to scale manufacturing capacity, ensure quality assurance, facilitate technology transfer, and create regulatory pathways that empower LMICs.  #WBGMeetings #IFCHealth

HOW THE W.H.O. RELY ON SILENCE TO PASS PANDEMIC TREATY AMENDMENTS! James Roguski on SubStack has been reporting on the so-called WHO Pandemic Treaty and it’s history. He has shown that it’s entire history is fraudulent and relies upon the people’s silence. On June 14th 1948, President Truman signed a joint resolution to sign onto the WHO constitution. Section two states that three US delegates would be chosen by the President and confirmed by the US Senate. But the Biden administration has sent US delegates who have not been confirmed. Which makes them fraudulent. Section five states that “in adopting this joint resolution, the Congress does so with the understanding that nothing in the Constitution of the World Health Organization in any manner commits the United States to enact any specific legislative program regarding any matters referred to in said Constitution.” And so the US is not lawfully compelled by the WHO. On July 25th 1969, the 22nd annual World Health Assembly adopted the International Health Regulations “to ensure the maximum security against the international spread of diseases.” But did so without a senate vote. “The way they did that was with what they call the silence procedure. A bunch of unnamed bureaucrats agreed to that document. They gave a nine month period for the leaders of all of the parties to reject it. And if no one rejected it on the first day of January 1971, it became legally binding. So any amendments go by that same adoption procedure. So in 2005, they made substantial changes. And for the last 18 or 19 years, we've been working off of the International Health Regulations as they were amended in 2005. I challenge anybody to look through the Federal Register or the Senate records to see if the Senate has ever given their consent, you know, two thirds, either in 1948 and 1969, 2005 or in 2022” ~ James Roguski On September 30th of 2022, ninety-four nations submitted more than 300 proposed amendments to the Pandemic Treaty. These documents were withheld from the public, and when James Roguski acquired copies, he discovered the reason for this was that the disputes were all based upon corrupt world leaders of smaller nations wanting a bigger piece of the action from the US after realizing the billions of dollars being made by pharmaceutical companies. More in link…

🌍 Contrasting Outcomes in Global Health and Intellectual Property 🌿 As WHO member states face a stalemate in negotiating a pandemic accord ahead of the World Health Assembly, a significant milestone has been achieved at the World Intellectual Property Organization (WIPO). A new treaty now mandates that patent applicants disclose the sources of indigenous plants and traditional knowledge used in their products, protecting these valuable resources, particularly in developing countries. This development has profound implications for pharmaceuticals, cosmetics, and beyond. Jamie Love of Knowledge Ecology International aptly describes the contrast: “It’s kind of like a wedding at WIPO and a funeral at WHO this morning.” #WIPO #WHO #PandemicAccord #IntellectualProperty #TraditionalKnowledge #GlobalHealth #Innovation #Sustainability https://lnkd.in/es89EEMA

Exciting developments at the 37th #AUSummit as African leaders celebrate progress towards establishing the #AfricanMedicinesAgency. With 27 countries already ratifying the treaty since its adoption in 2019, we're witnessing a crucial step towards enhancing healthcare across the continent. Now, let's unite in urging the remaining 28 AU Member States to ratify the Treaty, paving the way for a robust continental regulatory system that benefits patients, regulators, and healthcare systems alike. Let's also advocate for the African Union to engage with diverse stakeholders, tapping into the expertise of academia, research bodies, the private sector, and community groups. Together, we can ensure inclusive and effective healthcare solutions for all Africans. #HealthcareForAll #AU

📣 Calling All #Regulators! Our quarterly Regulator Forum takes place tomorrow! ⁉ Do you want to help shape regulatory collaboration and information exchange? ➡ The #Accumulus Regulator Forum is an opportunity to ensure your insights and perspectives are consistently captured. 🌐 Join 14 participating national regulatory authorities around the globe, plus the Bill & Melinda Gates Foundation, CEPI (Coalition for Epidemic Preparedness Innovations), and the World Health Organization, to provide feedback, drive innovation, and share your expertise. If you are a regulator interested in learning more, reach out to regulatory@accumulus.org or visit https://lnkd.in/e-QGfCu9 #regulatoryinnovation #digitaltransformation #regulatorforum #accumulussynergy

Last month, Latin America’s national regulatory authorities of reference discussed progress on a two-year-old plan to strengthen regulatory capacities across the Americas. In particular, officials with the agencies of Chile, Mexico, Argentina, Colombia, Cuba, and Brazil discussed pathways to becoming #WHO-Listed Authorities (WLAs).  WLA’s are an important instrument for #harmonization as they can help foster #regulatory #reliance. Read more in this #RAPS roundup: https://lnkd.in/gzfseEZc

For innovative health and life science companies, European competitiveness being at the forefront of the agenda in Brussels and beyond could help reverse the loss of cutting-edge science and investment to other parts of the world. The COMPET Council Conclusions, adopted on 24 May, highlighted that a future-proof industrial policy for Europe, including a strong intellectual property framework, should be an integral part of the Commission’s agenda in the next mandate. It could be the catalyst to prevent further decline, reverse these trends and build a healthier, more competitive, resilient and strategically autonomous Europe. EFPIA is publishing new data that demonstrates the importance of one aspect of IP –regulatory data protection (RDP) – to Europe, and how it is a key driver of patient access to new medicines and of innovation more widely. https://lnkd.in/dkVDyq8w

https://lnkd.in/gVkhENfB The World Trade Organization (WTO) fails to waive global patent rules for COVID-19 treatment, Paxlovid, leading to limited access in Africa, Asia, and Latin America. The slow response of the WTO to the pandemic raises questions about its relevance in global crisis management. The Pandemic Treaty, which advocates for shifting the authority to manage intellectual property related to pandemics from the WTO to the World Health Assembly. The past challenges with intellectual property rights in the health sector, particularly during the AIDS pandemic underscores the need for a more effective and timely response mechanism to ensure equitable access to medicines and vaccines during public health emergencies.

In a year’s time, the full implementation of the EU HTA Regulation will be upon us. Lumanity is here to help you prepare, so join our webinar next week for a whistle-stop tour of what we know about the regulation so far, as well as top tips on how to best prepare for the new regime. Sign up here: . #LumanityPerspectives #EUHTARegulation #HEOR #HTA