EBM 2/2018 Summer

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News Fighting Cancer MEPs have proposed to earmark €400m of the proposed €7.7bn Health pillar of the Horizon Europe programme to make pediatric cancers a chronic instead a deadly disease within the next 20 years. An strategy paper presented by EVP health rapporteur Peter Liese in May, proposes to double the current research budget for rare pediatric cancers that are neglected by the industry because of its low ROI. It calls for cross-border research, cross-linking of cancer registries for improved enrolment of patients into clinical trials, implementation of EU Health Technology Assessment for better access to treatments for all, and a push for digitalisation of patient data.

US loves sugar drinks  The US administration has torpedoed the WHO’s plan to recommend a 20%+ tax on oversugared drinks, intended to fight obesity, diabetes, cancer, and life-threatening secondary diseases. While most of the Commission on Non-Communicable Diseases’s 26 members backed a tax on sugar-sweetened beverages, the US representative blocked it. The move was enthusiastically welcomed by the International Food and Beverage Alliance (IFBA) — a foodgiant interest group that includes Coca-Cola (Atlanta) and PepsiCo. (Harrison). A growing body of evidence suggests that overweight- and sugartriggered inflammations initiate diseases that lead to 40 million deaths annually. Eric Hargan, the U.S. deputy secretary for Health and Human services, said there was no proof that a sugar tax would improve health outcomes.

European Biotechnology | Summer Edition | Vol. 17 | 2018

No hype but science Science   A new journal from Europe,

4open (www.4open–sciences.org), is set to break the current bias of leading science journals to overrepresented certain science trends vs excellent science stemming from fields that make less economic or funding impact. “When preparing 4open, we were seeking to attract any excellence in science. This includes every research result, positive AND negative, that helps advance science, in and outside the current trends. 4open is a journal both for established teams and young researchers,” said editor-in-chief, Prof. Dr. Björn Brücher. This summer the first papers will be published. 4open has a peer-reviewed, open-

Balancing CDMO’s competitivity Manufacturing The European Commission plans to back the rights of European generics and biosimilar makers against non-European competitors. Currently, EU producers are not allowed to export biosimilar versions of a drug produced in the EU right after expiry of its patent, because 86% of them have a Supplementary Protection Certificate (SPC) under Regulation EC 469/ 2009. SPCs extend patent protection for medicinal products that must undergo lengthy testing and clinical trials prior to obtaining regulatory market-

Commissioner Elzbieta Bienkowska

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access following a fair article processing charge model. 4open covers all four core disciplines of natural sciences: Life Sciences & Medicine (Editor-in-Chief Prof. Björn Brücher); (Chemistry & Applied Chemistry (Editor-in-Chief, TBA soon); Physics & Applied Physics (Editor-in-Chief Prof. Elias Brinks); and Mathematics & Applied Mathematics (Editor-in-Chief Prof. Theodore Simos), which includes Materials & Engineering. According to Dr. Claus Roll, Managing Editor at EDP Sciences, “the peer review process is entirely independent of the APC decision and will in no way alter any decision on scientific merit that the editor should take.” L

ing approval for 3.5 years on average. For non-EU biosimilar exporters this does not apply. At the end of May, Industry Commissioner Elzbieta Bienkowska proposed to introduce an ‘export manufacturing waiver’ to SPCs in order to “eliminate an unintended competitive disadvantage to Europe’s pharmaceutical companies when they go to export markets.” According to Bienkowska, the amendment could generate additional €1bn net sales per year for EU-based biosimilar makers. The waiver would allow EU companies to manufacture generics or biosimilars for export to non-EU markets where their protection has expired or never existed. Marc Alexander Mahl, President of Medicines for Europe, stressed that “the launch of the SPC manufacturing waiver legislative proposal is a very positive step to create manufacturing jobs in Europe, and to boost competitiveness by allowing EU companies to compete on a level playing field. However, this proposal should allow companies – especially SMEs – to prepare for ‘day 1 launch’ after expiry in Europe. Without this, European patients will not get timely access to European manufactured generic and biosimilar medicines. L

Picture: Aduiovisual Service of the EC


15.06.2018 11:24:34 Uhr

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