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Policies & Legislation

Labelling V14I26

ANVISA's decision on 'Skinny labels' for generics pending

Home/Policies & Legislation | Posted 14/11/2023

The Brazilian health regulatory agency, ANVISA (Agência Nacional de Vigilância Sanitária), is still considering whether to allow generic drug labelling to omit indications of the originator product that are still under patent.

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Advances in the availability of innovative medicines in Mexico

Home/Policies & Legislation | Posted 31/10/2023

A legal modification has recently been achieved for the faster recognition and release of innovative medicines on the Mexican market.

Law V13C29

More drugmakers sue over IRA yet one withdraws

Home/Policies & Legislation | Posted 10/10/2023

In the United States, Boehringer and Novartis join other drugmakers [1] in suing the US government over drug price negotiations in the Inflation Reduction Act (IRA). However, Japan-based Astellas Pharma withdrew its lawsuit filed against the US government in early September 2023.

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First drugs for Medicare price negotiation selected

Home/Policies & Legislation | Posted 22/09/2023

The US Department for Health and Human Security (HSS) has selected the first drugs for Medicare price negotiation.

Interchangeability V18K30

Updated Biosimilar Red Tape Elimination Act introduced by Senator Lee

Home/Policies & Legislation | Posted 25/08/2023

US Republican Senator for Utah, Mike Lee, has introduced an updated ‘Biosimilar Red Tape Elimination Act.’

Regulation V13H16

Inflation Reduction Act explained

Home/Policies & Legislation | Posted 24/07/2023

The US Assistant Secretary for Planning and Evaluation’s (ASPE) ‘Medicare Part B drugs: trends in spending and utilization 2008-2021’ was published in June 2023 [1]. This outlines aspects of the Inflation Reduction Act (IRA) which is designed to address the rapid rate of increase in Part B drug spending and lower costs for Medicare enrollees.

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AMLAC: regulatory agency for medicines in Latin America and the Caribbean established

Home/Policies & Legislation | Posted 13/06/2023

AMLAC, a regional body for Latin America and the Caribbean, is being set-up to promote greater access to safe, effective medical equipment and medicines through a combination of regional regulations.

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Pros and cons of tenders for generics and biosimilars

Home/Policies & Legislation | Posted 06/06/2023

An editorial entitled ‘Tenders for Generics and Biosimilars: A Challenging Purchasing Policy’ has been published in the European Journal of Health Economics [1]. It is authored by Fernando Antoñanzas, Carmelo Juárez-Castelló, and Roberto Rodríguez-Ibeas from the University of Rioja in Spain and discusses the challenges associated with the implementation of tendering processes for generics and biosimilars in healthcare purchasing policies.

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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?’

pill bottles V14K20

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].