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Policies & Legislation

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.

A call to end US drug pricing games

In a modern world dominated by personal choice, we still lack choice when it comes to health care. In the US, pharmaceutical companies play a drug pricing game that prevents low-cost medicines from being easily accessed by patients. In a commentary published in August 2019, Kathy Oubre, Chief Operations Officer of Pontchartrain Cancer Center in the US, outlined the details of drug pricing issues.

China eases generic medicine import laws

China has revised its drug administration laws to allow the import and sale of small quantities of generic drugs which are not approved in China. 

Praise for Canada’s BC after it adopts biosimilar transitioning policy

The Canadian Biosimilars Forum and Green Shield Canada have publicly commended the government of the province of British Columbia (BC) for announcing that it will implement biosimilar transitioning [1]. Here, patients will transition in a controlled manner from using a reference biological drug to its biosimilar. In their announcement, the Forum believes that BC will make big savings that will allow increased access to existing therapies and faster access to new medicines.