Policies & Legislation

Medicare drug price negotiation: what next?

Home/Policies & Legislation | Posted 30/05/2023

A commentary published in Value in Health by Dr Sean D Sullivan of the University of Washington School of Pharmacy offers insights into Medicare drug price negotiation [1]. The commentary discusses the implications of negotiation [2] and asks the question, ‘what next?’

Medicare drug price negotiation: implications

Home/Policies & Legislation | Posted 04/05/2023

In 2022, The Inflation Reduction Act (IRA) was signed into law in the US. This sets out to empower the US Secretary of Health and Human Services (HHS) to develop and implement methods and a process to negotiate a limited number of prescription drug prices in the Medicare programme directly with manufacturers [1]. A commentary by Dr Sean D Sullivan of the University of Washington School of Pharmacy, published in Value in Health, offers insights into the implications of Medicare drug price negotiation [2].

New guidance for Medicare Drug Price Negotiation Program

Home/Policies & Legislation | Posted 20/04/2023

The Centers for Medicare and Medicaid Services (CMS) released a memorandum that acts as a new guidance for the Medicare Drug Price Negotiation Program [1].

FDA and FTC join forces to promote competition in the biological market

Home/Policies & Legislation | Posted 14/04/2023

The Federal Trade Commission (FTC) and the US Food Drug Administration (FDA) are collaborating to promote market competition for biological drugs, including biosimilars and interchangeable biosimilars, which will help increase access to safe, effective and affordable treatments for patients.

EU and Latin America/Caribbean launch virtual marketplace for pharmaceuticals

Home/Policies & Legislation | Posted 31/03/2023

Under the Global Gateway umbrella, the EU and Latin America and the Caribbean (EU-LAC) are partnering on health resilience and vaccine production, and as part of this effort, they organized a high-level pharma forum and matchmaking event – the European Union - Latin America and Caribbean Summit – from February to April 2023.

The effects of regulation on innovation in Mexican pharmaceutical industry

Home/Policies & Legislation | Posted 09/03/2023

This article analysed the effect of regulation on the innovation processes in the pharmaceutical industry. The research was exploratory in nature and the design used was a case study, corresponding to the development of a new medication for treating diabetes by a Mexican pharmaceutical company [1].

FDA publishes BsUFA III research roadmap

Home/Policies & Legislation | Posted 03/03/2023

In early 2023, the United States Food and Drug Administration (FDA) published their Biosimilar User Fee Act (BsUFA) III research roadmap [1] as part of their regulatory research pilot programme [2].

The US Biologics Competition Act and Biosimilar Red Tape Elimination Act

Home/Policies & Legislation | Posted 27/01/2023

The US introduced the Biologics Competition Act of 2022 (HR 887) in September 2022. This was followed by the introduction of the Biosimilar Red Tape Elimination Act in November 2022. Both acts seek to make biosimilar products more accessible and increase their uptake in the US.

EU public consultation on revised framework for compulsory licensing of patents

Home/Policies & Legislation | Posted 25/11/2022

The European Commission had opened a public consultation on ‘Intellectual property (IP) – revised framework for compulsory licensing of patents’. This was opened from 7 July 2022 to 29 September 2022.

Canada upholds decision to approve biosimilars where reference product is not marketed

Home/Policies & Legislation | Posted 30/09/2022

In court proceedings that concluded in August 2022, the Canadian Federal Court dismissed applications for judicial review put forward by AbbVie regarding the approval and marketing authorization of JAMP Pharma's Simlandi (adalimumab) product [1]. This confirms that Notice of Compliance (NOC) regulations do not apply to biosimilars when reference products are not marketed in Canada.