Policies & Legislation
Implications of Canadian–European Trade Agreement for generics
On 26 September 2014, Canada and the European Union (EU) successfully concluded negotiations on a trade deal, which will free the movement of goods, services, investment and labour between the two regions. However, some of the provisions in the agreement have been criticized by generics makers for delaying access to medicines by having a negative effect on the generics industry in Canada.
Idaho proposes legislation on biosimilars substitution
The Idaho Board of Pharmacy held a hearing on 5 and 6 August 2014 regarding proposed regulations for the treatment of biosimilars in their state.
Servier and generics makers fined for pay-for-delay
French drugmaker Les Laboratoires Servier (Servier) and five generics companies have been fined a total of Euros 427 million by the European Commission due to practices delaying the entry of generic perindopril, a medicine to treat high blood pressure.
EC expected to dish out more pay-for-delay fines
The European Commission (EC) is planning to fine French drugmaker Les Laboratoires Servier (Servier) and generics giant Teva Pharmaceutical Industries (Teva) in its latest round of investigations over so-called ‘pay-for-delay’ deals.
Companies required to update information on drugs
The European Medicines Agency (EMA) announced that as of 16 June 2014 marketing authorization holders would be required to update the information on medicines authorized in the European Union.
EMA changes transparency plans to increase access to data
The European Medicines Agency (EMA) has done an about-turn on its data transparency plans after the agency’s draft on the conditions of use for the EMA interface were criticized for limiting access to clinical trials data.
Massachusetts governor signs biosimilars substitution bill
Massachusetts has become the latest US state to pass a law allowing substitution of a biosimilar for an originator biological, but with certain restrictions.
Court rules Canadian drug regulators cannot control generics' prices
Canada’s Patented Medicine Prices Review Board (PMPRB) has been told that it has no jurisdiction over the pricing of generics.
EMA criticized for change in data transparency plans
New Legislation approved by the European Parliament on 2 April 2014 aims to increase transparency with respect to clinical trials by making the results publicly available. The Clinical Trials Regulation, which is expected to take effect in 2016, will require the results of all new clinical trials to be published within a year of the trial ending. The way, however, that the European Medicines Agency (EMA) is proposing to make this data available has been criticized.
France to allow biosimilars substitution
Pharmacists in France will now be allowed to substitute a biosimilar for the prescribed (reference) biological under certain conditions, including only when initiating a course of treatment and that the prescribing physician has not marked the prescription as ‘non-substitutable’.
