Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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22 Sept. 2021
The rapid development of effective Covid-19 vaccines in 2020 gave hope to the world in the darkest days of the deadly pandemic. However, the vaccine roll-out has been massively skewed towards wealthy nations. While rich states have hoarded vaccines, companies have also played a decisi...ve role in restricting fair access to a life-saving health product. This report focuses on six leading vaccine developers, AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax and Pfizer, assessing each company’s human rights policy, pricing structure, records on intellectual property, knowledge and technology sharing, allocation of available vaccine doses and transparency.
Available in Arabic, English, French, German and Spanish
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Adapted from CURRENT Medical Diagnosis & Treatment 2010
Irresponsible pharmaceutical companies fuel the proliferation of superbugs through supply chain pollution, the European Public Health Alliance (EPHA) reports. The advocacy group uncovered lapses such as dirty production and inadequate waste disposal in the production of antimicrobials in China and I...ndia, which supplies most of the antimicrobials consumed in Europe. In a briefing detailing the pollution, the EPHA urges major purchasers of antibiotics to blacklist irresponsible pharmaceutical companies, demand that the industry clean up its supply chain, introduce greater transparency on the origin of antibiotics, and review and revise procurement policies from an ethics perspective.
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WHO Annual Meeting with Pharmaceutical Companies and Stakeholders
08 March 2016, Geneva
2015-06-03 - Board presentation - v32.pptx
Join the campaign to call on countries and companies to ensure that by the time World Health Day arrives on 7 April, COVID-19 vaccines are being administered in every country, as a symbol of hope for overcoming both the pandemic and the inequalities that lie at the root of so many global health chal...lenges.
This call to action can be fulfilled through supporting COVAX and the ACT Accelerator to equitably distribute vaccines, treatments and diagnostics globally.
Sign the declaration!
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This guidance will assist the transportation sector, including transport authorities, companies, independent or informal drivers, and passengers, in addressing coronavirus disease 2019 (COVID-19) for different outbreak phases as defined in the Africa CDC Stepwise Response.
This guidance complements... the Africa CDC Guidance for Community Physical Distancing, which includes further details on how to engage communities, implement physical distancing, and support organisations, and the Africa CDC Guidance for Community Use of Face Masks.
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CDP is a not-for-profit charity that runs the global disclosure system for investors, companies, cities, states and regions to manage their environmental impacts. Over the past 20 years we have created a system that has resulted in unparalleled engagement on environmental issues worldwide.
Résumé.
Malgré les efforts de promotion des mutuelles de santé depuis une décennie et l’existence d’une vingtaine de compagnies privées proposant des polices d’assurance maladie, moins de 1% de la population camerounaise bénéficie d’une couverture maladie. Les facteurs sous jacents ...sont entre autres : (i) la méfiance des ménages vis-à-vis des mutuelles de santé et des assureurs privés; (ii) l’absence d’obligation d’une assurance maladie qui en fait un produit de luxe ; (iii) l’ignorance des avantages des mécanismes assurantiels; (iv) la pauvreté et le montant élevé des primes d’adhésion et des cotisations annuelles ; et (v) la forte prévalence de l’emploi dans le secteur informel (80,6%). Pour y faire face nous proposons de : 1) Créer et pérenniser un environnement favorable à la promotion et au développement des MS ; 2) Subventionner les primes par le Gouvernement, les Partenaires et les Municipalités pour en réduire le prix d’achat ; 3) Instituer une collecte flexible des primes et établir un dispositif attractif de mutualisation du risque et des procédures d’achat qui inspirent confiance aux usagers et aux prestataires des soins.
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Millions of people today cannot access medicine when they need to. This can be due to price, empty pharmacy shelves or other factors. Find out more about the situation and how the Index stimulates pharmaceutical companies to help turn it around.
Accessed on 22.04.2023
To target helminth elimination, a new consortium of research institutes, universities, not-for-profit organizations, and pharmaceutical companies have joined forces and expertise to establish a research and development pipeline for the development of anthelminthics targeti...ng nematodes. The focus is on STH as well as onchocerciasis.
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This report provides an update on the key facets of HIV treatment access, including the latest HIV treatment guidelines from World Health Organization (WHO), an overview on pricing for first-line, second-line, and salvage regimens, and a summary of the opportunities for – and threats to – expand...ing access to affordable antiretroviral therapy (ART).
The report is supplemented by 11 drug profiles that contain more detailed information on pricing trends and patent barriers for key antiretroviral drugs and fixed-dose combinations. Also included is an annex of conditions that define eligibility for reduced prices from 15 pharmaceutical companies.
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The World Health Organization was requested by Member States to develop a global priority pathogens list (global PPL) of antibiotic-resistant bacteria to help in prioritizing the research and development (R&D) of new and effective antibiotic treatments. To date, the selection of pathogens for R&D ac...tivities has been largely guided by small and large pharmaceutical companies according to a variety of parameters, such as perceived/unmet medical need, pressure of investors, market size, scientific discovery potential, and availability of specific technologies. Previous PPLs, issued by the Centers for Disease Control and Prevention.
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In 1988, the Centre for Research on the Epidemiology of Disasters (CRED) launched the Emergency Events Database (EM-DAT). EM-DAT was created with the initial support of the World Health Organisation (WHO) and the Belgian Government.
The main objective of the database is to serve the purposes of h...umanitarian action at national and international levels. The initiative aims to rationalise decision making for disaster preparedness, as well as provide an objective base for vulnerability assessment and priority setting.
EM-DAT contains essential core data on the occurrence and effects of over 22,000 mass disasters in the world from 1900 to the present day. The database is compiled from various sources, including UN agencies, non-governmental organisations, insurance companies, research institutes and press agencies.
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Welcome to the SDG Academy!
The SDG Academy creates and curates free, graduate-level courses on sustainable development for students around the world.
From sustainable cities to human rights to climate action, each of our courses addresses the fundamental challenge facing our world today: How ...do people, communities, governments and companies not only coexist, but also cooperate and collaborate, to save the one planet we have?
As a massive open online education platform, SDG Academy's courses are fully interactive, so you can meet, debate and learn from both our global faculty of sustainable development experts and your fellow students.
Learn more here about the SDG Academy – an initiative of the Sustainable Development Solutions Network – and the SDG Academy student experience.
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Slavery on fishing vessels, degradation of ecosystems, overfishing, debt bondage, human trafficking and child labour in peeling sheds – the scandals surrounding the Thai fishery and shrimp industries have garnered international censure. Farmed and processed at the cost of extreme exploitation of b...oth people and the planet, Thai shrimp ends up on plates around the world. The former delicacy can now be bought cheaply everywhere. But how high is the price really? And who has to pay it?
This report by seeks to remind governments in the countries of production that it is their duty to enforce human rights and living wages, rather than to compete for the favour of large companies to the detriment of people and the environment. It also appeals to consumers and their governments – and to importers – to send a clear message to suppliers in Thailand and elsewhere: If you want to survive on the global market, you need to respect human rights and child rights, and uphold social and environmental standards.
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The Guidelines for the Diagnosis, Treatment and Prevention of Leprosy provide state-of-the-art knowledge and evidence on leprosy diagnosis, treatment and prevention based on a public health approach in endemic countries. The target audience of this document includes policy-makers in leprosy or infec...tious diseases in the ministries of health (especially but not limited to endemic countries), nongovernmental organizations, clinicians, pharmaceutical companies, donors and affected persons
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Globally each year, millions of people suffer illness or lose their lives because the vaccines, medicines and diagnostic tests that they need are either unavailable or unaffordable – and this lack of access to medicine is acute in low- and middle-in-
come countries (LMICs). While the COVID-19 pan...demic laid this inequity bare, it also saw the pharmaceutical industry develop and bring new vaccines and treat- ments to market at unprecedented speed. As the world emerges from the worst
of this crisis, pharmaceutical companies are now at an important juncture, where lessons learned from the pandemic can prove pivotal in finding solutions to bridge long-standing gaps in access to medicine in LMICs.
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Governments have dedicated a pivotal role to the private sector in the implementation and financing of the 2030 Agenda and the SDGs. This has pushed a turn towards the private sector, the promotion of multi-stakeholder partnerships between public and private actors. However, far too often there is a... considerable gap between the social and environmental commitments companies make publicly in political fora like the UN and the actual effects of their production patterns and investment strategies on people and the environment. A new working paper, published by Brot für die Welt, Global Policy Forum and MISEREOR provides an overview of the ways and means by which the UN involves business actors in the debates around the implementation of the 2030 Agenda. It describes new initiatives and alliances of business actors around SDG implementation at the international level, and their main messages and policy proposals. With a few selected examples it contrasts the sustainability rhetoric of corporations with their business reality. And finally, the working paper draws conclusions and formulates recommendations for policymakers on how to increase the benefits of UN-business interactions in implementing the 2030 Agenda - and how to reduce associated risks and negative side effects.
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SHOPS and HIA finalized a scope of work with USAID Senegal in April 2015, and a team of five private sector experts conducted the onsite assessments between May and June 2015. The Private Sector Assessment (PSA) team worked closely with Senegalese key stakeholders throughout the process. The PSA tea...m interviewed more than120 individuals from approximately 78 organizations, including the government of Senegal (GOS), donors, USAID implementing partners, private sector umbrella organizations, private insurance companies, faith-based organizations (FBOs), nongovernmental organizations (NGOs), private health care facilities, and private pharmacies.
Through stakeholder interviews and review of government reports and online resources, the assessment team noted the following findings by theme.
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