Policies & Legislation
UK authority accuses Actavis UK and Concordia of illegal agreement
The UK’s Competition and Markets Authority (CMA) alleged that pharmaceutical companies, Actavis UK and Concordia, entered into illegal agreements that allowed them to increase and maintain high prices of hydrocortisone tablets.
India and Argentina call for hepatitis C generics
The high prices of hepatitis C drugs push the need for more generic versions to be approved worldwide. On 13 February 2017, Médecins Sans Frontières (MSF, Doctors Without Borders) reported that organizations in India and Argentina filed cases against the patents of certain hepatitis C drugs.
EMA and FDA to recognize GMP inspections
European Union (EU) and US regulators have agreed to recognize inspections of drugmakers in Europe and the US.
Ireland to publish biosimilars report
Ireland’s Minister for Health Simon Harris is to publish a consultation on biosimilars, he announced at a recent conference. The Minister discussed his hopes to increase their use and provide significant savings for the Irish healthcare budget.
British oncologists back biosimilar mAbs to treat cancer
The British Oncology Pharmacy Association (BOPA) announced on 7 February 2017 the publication of its position statement and implementation guidelines on Biosimilar Monoclonal Antibodies.
World Trade Organization allows generics imports into developing countries
The World Trade Organization (WTO) has amended its intellectual property agreement to allow developing countries with limited drug production abilities to import generic drugs.
US Supreme Court to review 180-day notice for biosimilars
The US Supreme Court announced on 13 January 2017 that it has agreed to hear a case centred on whether biosimilar makers have to give 180 days of notification to the originator biological manufacturer before launching their biosimilar.
UK fines Pfizer and Flynn following epilepsy drug price hikes
The UK Competition and Markets Authority (CMA) has fined Pfizer and Flynn Pharma a combined total of almost GBP 90 million (US$110 million) for increasing the prices of phenytoin anti-epilepsy tablets by over 2,000%.
Colombia slashes price of cancer treatment Glivec
The Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social, MinSalud) has unilaterally ruled to cut the price of Novartis’ blockbuster leukaemia drug, Glivec (imatinib), by 44%.
Japan joins international GMP collaboration
The European Medicines Agency (EMA) announced on 25 November 2016 that it would be expanding its ongoing collaboration on good manufacturing practice (GMP) inspections of active pharmaceutical ingredient (API) manufacturers to include Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
