Policies & Legislation
European Court of Justice backs UK in pay-for-delay fine against GSK
The European Court of Justice has backed an earlier decision by the UK financial regulator, the Competition and Markets Authority (CMA), to fine pharma giant GlaxoSmithKline (GSK) in connection with ‘pay for delay’ deals for one of its off-patent medications.
New pricing system for drugs in Russia
The Russian Government has passed a decree mandating ceiling prices for drugs on the country’s essential drugs list.
Chemically synthesized polypeptides to use biosimilars pathway
The US Food and Drug Administration (FDA) is supporting a change in the government spending bill that will allow for chemically synthesized polypeptides to also be classified as biologicals.
US government department proposes rule to lower drug prices for its citizens
The US Department of Health and Human Services (HHS) announced a string of changes in November 2019, including a proposal to lower drug prices for US citizens based on Trump’s ‘most favored nation’ approach.
US and EU sign milestone mutual recognition agreement
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have signed a historic mutual recognition agreement which means the US will now recognize the good manufacturing practice (GMP) inspections of all EU Member States, and vice versa.
UnitedHealthcare sues generics manufacturers for price fixing
US health insurance giant UnitedHealthcare has filed a lawsuit against 25 generic drugs manufacturers, accusing them of scheming to increase the prices of over 100 different drugs.
Bill to stop misuse of Citizen Petitions advances in the House
On 13 November 2019, the House Energy and Commerce’s health subcommittee unanimously advanced a bipartisan bill aimed at preventing companies from using citizen petitions to delay the approval of generics.
Concerns raised as Canada’s Alberta plans to switch patients to biosimilars
Canada’s province of Alberta is planning to stop coverage of originator biologicals and switch patients to biosimilars for certain indications.
US Senators reveal plans to lower drug prices
The House Ways and Means Committee have approved Speaker Nancy Pelosi’s drug pricing bill, while Democratic nominee Pete Buttigieg has disclosed his own drug pricing plan that would impose penalties on ‘worst offender’ pharmaceutical companies.
Canada amends its drug pricing regulations
The Canadian Government has released final amendments to its Patented Medicines Regulations. The amendments, according to the Canadian Government, represent ‘the most significant reforms to the regulations since their introduction in 1987’ and are also a significant departure from the existing framework.
