Europe Edward Mc Gettrick and Sharon Gorman of Pfizer, writing in the January 2023 edition of DIA’s Global Forum magazine, examine the scope and impact of the European Union’s new Regulation on Health Technology Assessment. In December 2021, the European Commission (EC) adopted the Regulation on Health Technology Assessment (EU HTA…
Greece The European Union’s decision to mitigate the effects of the COVID-19 pandemic by launching its Recovery and Resilience Facility (RRF) and moving away from its past austerity policies is particularly significant for Greece. Severely hit by the financial crisis a decade ago and thrown off its course to recovery by…
Global Antimicrobial resistance (AMR), or the resistance of pathogens to antibiotics, antivirals, antifungals and antiparasitics has been declared by the World Health Organization (WHO) as one of the top 10 global public health threats and was associated with the death of some 5 million people in 2019. The latest WHO report…
France The latest news from French pharma, including fears of medicine shortages and suspension of online sales of paracetamol, CARMAT’s artificial heart product entering a study in France, Sanofi’s expanded deal with Innate Pharma and new funding for cell and gene therapy biotech Cellectis. France suspends internet sales of paracetamol …
Germany In response to a looming deficit of EUR 17 billion, Germany’s new Financial Stabilization of Statutory Health Insurance System Act (GKV-Finanzstabilisierungsgesetz, or GKV-FinStG) is aimed at containing costs in the country’s health insurance system by distributing the financial burden amongst all healthcare stakeholders, yet biopharma companies stand to be hit…
Europe Based on current discussions by the European Commission, launch conditionalities would not account for the distinct nature of small and mid-sized companies, OMPs and ATMPs. EUCOPE’s Alexander Natz breaks down this aspect of the revision of the general pharmaceutical legislation and why it would prove unsustainable for smaller companies and…
Europe Writing in the special December 2022 edition of DIA’s Global Forum magazine, Eli Lilly’s Mark Mayer, Pfizer’s Nick Sykes and Julie O’Brien, and the EFPIA’s Sini Eskola, Magda Chlebus, and Chloé Garay look at the EU regulatory system’s resourcing challenges and call for long-term multi-stakeholder engagement to help resolve them.…
Spain What major regulatory trends are emerging in Europe and in Spain? As one of the founding partners of a law firm focused uniquely on the life sciences industry, Faus & Moliner Abogados, Jordi Faus has been confronting the industry’s unique legal issues for over 25 years. In a recent PharmaBoardroom…
Greece In Greece, both innovators and the generics industry find fault with the country’s rebates and clawbacks system, a hold over cost-containment measure from the country’s period of extreme economic turmoil. In conversation with PharmaBoardroom, Michael Himonas, GM of the Hellenic Association of Pharmaceutical Companies (SFEE) and Faye Kosmopolou, GM of…
Spain Faus & Moliner Abogados is a Spanish law firm that has been specializing in pharma and life sciences law since 1997. Founding partner Jordi Faus explains how having a comprehensive knowledge of the industry has become the firm’s competitive edge. He discusses the push for regulatory innovation among European regulators,…
Italy After former CEO Pierluigi Antonelli abruptly announced his departure last month, the Italian mid-cap has signed on former Gilead leader, Jacopo Andreose, as its new chief executive. [I am] looking forward to joining the Angelini team and helping to chart the next chapter for [Angelini] Pharma. Jacopo Andreose Abrupt…
Greece Faye Kosmopolou of Greek generic industry association PEF discusses Greece’s potential as a pharma manufacturing hub for Southeast Europe post-COVID, the challenges of overcoming low generic penetration rates in the domestic market, and why she is optimistic for the future of Greek pharma moving forward. Greece is the only…
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