Category Europe

Agreement On SPC Manufacturing Waiver Reached, Benefitting EU Generic, Biosimilar Industry

The European Council reached a political agreement today on the SPC Manufacturing Waiver, which will allow the manufacture of generic and biosimilar medicines in the European Union for export and stockpiling during the period of extended patent protection provided for by the EU. This waiver will enable EU generic and biosimilar industries to benefit from sales outside the EU where patents have already expired, and to prepare to provide the EU market as soon as the extended period of patent protection ends.

EU Copyright Rules: Provisional Deal Struck On Changes

The European Council's Romanian presidency announced today it has struck a provisional agreement with the EU Parliament on a draft directive that makes changes to existing European Union copyright rules. The draft agreement, which will go before the full Council of member states and Parliament for approval, would make changes such as a controversial new "publishers' right," and strengthens copyright protections on online content sharing platforms. It also would introduce copyright exceptions for a range of purposes such as text and data mining, online teaching, and cultural heritage.

DNDi, MMV Make 400 Compounds Available To Boost Pandemic Disease Research

The Drugs for Neglected Diseases initiative (DNDi) and Medicines for Malaria Venture (MMV) today announced the launch of the "Pandemic Response Box", which offers researchers open access to 400 compounds that could lead to development of new treatments for pandemic diseases. In return, researchers "will be expected to share data resulting from research on the molecules from the box in the public domain within 2 years of its generation." 

Sudden Vacancies At Some International Agencies, Industry Sees New Top Officials, Lawyers Engage In Firm-Hopping

While the World Bank Group and the United Nations Environment Programme (UNEP) are looking for new leaders following the unexpected resignations of their heads, the International Telecommunication Union re-elected its secretary general. The European Patent Office got two new vice-chairs, and the European Organization for Nuclear Research (CERN) a new president, both starting in January. Associations for the creative industry and the pharmaceutical industry also elected new top officials, and lawyers continued to practice firm-hopping.

Nearly 100 European Authors Demand ‘Proportionate’ Remuneration In EU Copyright Directive

With negotiations for the European Union Copyright Directive apparently approaching an end, a group of some 95 screenwriters and directors joined the intensive lobbying efforts with a letter today urging that a principle of "proportionate" remuneration to them be enshrined. The letter spells out several elements they argue are key to ensuring European audiovisual authors are able to "make a living from our craft and creativity."

European Council Advances SPC Waiver For Generics; Negotiations Coming

The European Union Council of member states has approved a mandate for negotiations with the EU Parliament concerning a draft regulation aimed at boosting EU-based generic and biosimilar manufacturing for export by providing an exception to the extended intellectual property protection granted by special protection certificates (SPCs). The mandate brings the draft regulation a step closer to adoption, and it also suggests that Parliament’s recent amendments to the regulation are likely be key areas of debate in the negotiations, which are expected to begin in the coming weeks.

Supporting UHC And Better Explaining IP – The 2019 Pharma Industry Agenda

In 2019, IFPMA work will continue to focus on constructive engagement in supporting UHC and working with others to strengthen health care systems. The association will continue to engage with a range of stakeholders, particularly multilateral organizations, to better explain the benefits of IP and exchange ideas to address issues of coverage, capacity, affordability and sustainability of healthcare.

Time To Put A Stop To The Abuse Of Orphan Drug Regulation- The Latest Scandal

Ellen 't Hoen writes: Today, the Dutch Medical Journal (Nederlands Tijdschrift voor Geneeskunde) reported on the case of lutetium-octreotaat, a cancer drug developed by researchers in the Dutch Erasmus medical centre in Rotterdam. For the last 18 years, the hospital pharmacy made the medicine to treat their patients, keeping prices relatively low. But now the drug is being marketed by Swiss pharmaceutical giant Novartis, and its price has skyrocketed to Euro 23,000 an infusion from an original price of Euro 4,000 an infusion.