Policies & Legislation

US Senators reveal plans to lower drug prices

Home/Policies & Legislation | Posted 08/11/2019

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

Home/Policies & Legislation | Posted 25/10/2019

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

Home/Policies & Legislation | Posted 27/09/2019

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

Home/Policies & Legislation | Posted 20/09/2019

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

Home/Policies & Legislation | Posted 06/09/2019

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.

China audits drug companies

Home/Policies & Legislation | Posted 23/08/2019

In June and July 2019, China embarked on an audit of 77 major pharmaceutical companies, including the local arms of Sanofi, Eli Lilly & Co and Bristol-Myers Squibb Co. This action was undertaken after one of its largest listed drug manufacturers overstated its cash position by US$4.3 billion. The announcement called an index of healthcare companies traded in Shanghai and Shenzhen to fall by 1.8%.

IPRP expands and all EU Member States now included in EU-US MRA

Home/Policies & Legislation | Posted 16/08/2019

During the June 2019 International Pharmaceutical Regulators Programme (IPRP) management committee meeting in Amsterdam, The Netherlands, it was announced that Iran’s National Regulatory Authority (NRA) and Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT – Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) have joined the IPRP. There are now 26 members of IPRP.

Bill introduced in US to cut insulin prices

Home/Policies & Legislation | Posted 09/08/2019

Co-Chair of the Senate Diabetes Caucus, Senator Jeanne Shaheen, announced on 22 July 2019 the introduction of new legislation to combat rising insulin prices.

Bipartisan bill aims to reduce healthcare costs in the US

Home/Policies & Legislation | Posted 02/08/2019

Senators Lamar Alexander and Patty Murray recently introduced the ‘Lower Health Care Costs Act of 2019’. The bipartisan bill includes 54 different proposals from 65 senators (36 Democrats and 29 Republicans), all aimed at lowering the cost of health care.

US FDA acts to improve transparency and predictability for new generics applications

Home/Policies & Legislation | Posted 26/07/2019

On 18 June 2019, the US Food and Drug Administration (FDA) released a ‘Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high quality, lower cost generic drugs’. Here, the agency outlines that, to facilitate American patients’ access to lower-cost generic medicines, they are taking steps to enhance and streamline the development and approval process of high quality generic drugs.

Canada’s British Columbia to switch patients to biosimilars

Home/Policies & Legislation | Posted 21/06/2019

British Columbia has become the first Canadian province to stop coverage of originator biologicals and switch patients to biosimilars for certain indications.

Bulgaria and Cyprus added to EU-US mutual recognition agreement

Home/Policies & Legislation | Posted 14/06/2019

The European Medicines Agency (EMA) announced on 29 April 2019 that the mutual recognition agreement (MRA) between the European Union (EU) and the US had been extended to include two additional EU Member States, Bulgaria and Cyprus.

US considering eight years protection for biologicals in China

Home/Policies & Legislation | Posted 07/06/2019

Makers of copy biologicals in China may be set to get a further boost, as the Trump administration is said to be considering conceding to China’s proposal to shorten the period of protection granted to US drugmakers’ biologicals in the country.

FDA’s Orange and Purple Books to be improved and updated

Home/Policies & Legislation | Posted 31/05/2019

On 8 May 2019, the US House of Representatives unanimously passed two bills that aim to enhance the utility of the US Food and Drug Administration’s (FDA) Orange Book for generics makers and the Purple Book for biosimilars makers.

New biosimilar guide for pharmacists in Australia

Home/Policies & Legislation | Posted 24/05/2019

During the Generic and Biosimilar Medicines Association’s (GBMA) Biosimilar Week, Federal Minister for Health, Greg Hunt, introduced Biosimilar Week 2019 along with the launch of the Biosimilar Hub, which included a set of specific guidelines geared towards pharmacists.

Automatic pharmacist substitution of biosimilars in Germany

Home/Policies & Legislation | Posted 10/05/2019

Pharmacists in Germany may soon be able to carry out automatic substitution of biosimilars in the country.

Australia’s TGA considering whether to publish drugs under evaluation

Home/Policies & Legislation | Posted 03/05/2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) is consulting on whether it should publish that a prescription medicine is under evaluation.

Health Canada announces naming convention for biologicals

Home/Policies & Legislation | Posted 26/04/2019

Following a number of stakeholder consultations including the 2018 Consultation on the Naming of Biologic Drugs [1], Health Canada has decided that biological drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix. Under this naming convention, both the brand name and non-proprietary name should be used throughout the medication use process so that biologicals that share the same non-proprietary name can be distinguished by their unique brand names.

Online consultation on biological drug naming in Canada

Home/Policies & Legislation | Posted 19/04/2019

Health Canada and the Institute for Safe Medication Practices Canada conducted an online consultation on the naming of biological drugs in 2018.

US government advances five bills to increase generics competition

Home/Policies & Legislation | Posted 12/04/2019

The US House Energy & Commerce Committee’s Health Subcommittee has advanced five bills related to generic drug competition. The bills have not yet been passed but will each be considered by the full committee.

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