Industry Watch [to 18 June 2016]

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:: Systematic Review of 58 Publications of Real-World Use of GARDASIL® Presented at EUROGIN Congress
Studies Published over the Last 10 Years Report Reductions in Cervical Pre-cancers and Other HPV-related Diseases
June 16, 2016
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside of the United States and Canada, announced today that in a systematic review conducted of the global impact and effectiveness of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], substantial reductions were observed in HPV 6/11/16/18-related infection, genital warts, Pap abnormalities and cervical pre-cancers. This evaluation of 58 effectiveness and impact studies published during the past 10 years examined the use of GARDASIL in routine vaccination programs in Australia, Europe, North America and New Zealand, and will be presented for the first time during an oral session at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) congress in Austria. A paper detailing this review was also published online on June 14 in the journal Clinical Infectious Diseases (CID).

Following introduction of vaccination programs with GARDASIL, the earliest impact of the vaccine was seen in the reduction of genital warts. Reductions in genital warts were observed in all nine countries included in this review (based on 28 publications), with declines occurring as early as one year after vaccine introduction in Australia and Germany. Reductions in HPV 6/11/16/18 infection, assessed in 14 publications from five countries (Australia, Belgium, Germany, Sweden and the United States), were also observed shortly after vaccination; for example, reductions in HPV 6/11/16/18 infection were seen within four years in several studies from Australia and the United States. Subsequently, as successive birth cohorts began cervical screening, reductions in cervical pre-cancers were observed within 3-5 years of vaccine program implementation in Australia, Canada, Denmark, Sweden and the United States…

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:: Biopharma contributes to key global health discussions at WHA69
17 June 2016
:: New resolutions adopted by the World Health Assembly included rules on relations the World Health Organization can have with the private sector, amongst others; structures for R&D funding and coordination; access to medicines and integrated health services; global sector strategies on HIV, hepatitis and STIs.
:: Decisions have been taken also on important public health issues: Anti-microbial Resistance (AMR); the implementation of health-related Sustainable Development Goals (SDGs).
:: Numerous satellite events (including two hosted by the IFPMA and several by IFPMA members) enriched the week of deliberations.

Geneva, 6 June 2016 – The 69th World Health Assembly (23-28 May 2016) concluded with 193 countries taking decisions on a number of important issues that will shape the global health agenda and guide the World Health Organization’s (WHO) work in the years to come. As an organization in official relations with the UN, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) made three statements at this year’s World Health Assembly.

FENSA – After years of complex negotiations, the World Health Organization’s (WHO) Framework for Engagement with Non-State Actors (FENSA) was adopted. The resolution asks for immediate implementation of the framework and the full establishment of the register of Non State Actors. It provides the organization with policies and procedures on engaging with non-governmental organizations, private sector entities, philanthropic foundations, and academic institutions. IFPMA has official relations with WHO which will help maintain a close working relationship with the organization.

CEWG – The WHO resolution on research and development funding and coordination (Consultative Expert Working Group/CEWG) saw Member States agree to operationalize the Global Observatory on Health R&D, proposing a way forward to a voluntary pool funding mechanism.

AMR – A report presenting options for establishing a global development and stewardship framework for antimicrobials was noted. Member States highlighted the importance of the “one health” approach to anti-microbial resistance (AMR), strengthening infection prevention and control national strategies, surveillance and laboratory capacities, and the need to regulate the use of antibiotics without hampering access…