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Policies & Legislation

Teva not liable in US due to FDCA implied preemption

In early 2021, implied preemption related to the Federal Food, Drug and Cosmetic Act of 1938 (FDCA or the Act) has prevented generics manufacturer Teva Pharmaceuticals (Teva) from being held liable for three different failure-to-warn theories.

China improves generics injection consistency evaluation

China’s National Medical Products Administration (NMPA) announced regulatory improvements to the generic injections’ quality and efficacy consistency evaluation in May 2020.

Italy simplifies over-the-counter generics price and reimbursement

The Italian Drugs and Medicines Agency (Agenzia Italiana del Farmaco, AIFA) has simplified its price and reimbursement procedure for class C generic/biosimilar medicines. As of February 2021, generic/biosimilar versions of over-the-counter class C reference products will automatically be classified as class C products.

Australia launches new medicines road map and substitution policy

The Australian Government has launched a Medicine-Medical Product Manufacturing Road Map and new legislation to support medicine substitutions.

Problems with the tiered pricing policy for generics in Korea

In order to try to improve the quality of generics and ensure an efficient and competitive generics market, the Korean Ministry of Food and Drug Safety (MFDS) introduced a ‘tiered system’ to restructure the drug pricing for generics in July 2020. However, since its introduction the system has not gone without criticism.

EMA and EU medicines regulatory joint five-year strategy

The Europeans Medicines Agency (EMA) and the European Union’s (EU) Heads of Medicines Agencies (HMA) have published their joint strategy to 2025: Protecting public health in a time of rapid change [1].

Biden vows to protect Obamacare and increase reliance on quality generics

President-elect Joe Biden plans to protect and strengthen the Affordable Care Act, the public health insurance scheme passed in 2010 by then President Barack Obama. Over the last few years, the Affordable Care Act has been under relentless attack [1], and the US Supreme Court is currently considering a case attempting to strike down the law.

Changes to New Zealand law for quick access to COVID-19 vaccine

The global race for COVID-19 vaccines is on. New Zealand has allocated hundreds of millions of dollars in a bid to get quick access to a vaccine, once found. Although the actual sum has not yet been revealed, this is in addition to its NZ$37 million vaccination strategy. 

AbbVie accused of anticompetitive tactics to stop Humira biosimilars

Pharmaceutical manufacturer AbbVie faces another legal challenge related to anticompetitive tactics in the US. On 12 October 2020, the US Public Interest Research Group (US PIRG) filed an appeal accusing AbbVie of employing tactics that have delayed market entry of biosimilars.

China’s draft measures for patent linkage system

China’s National Intellectual Property Administration (CNIPA) and the National Medical Products Administration (NMPA) published draft measures entitled ‘Implementing measures for drug patent dispute early resolution mechanism (trial for implementation)’ on 11 September 2020. These outline further aspects of the patent linkage system that were presented in July’s proposed amendments to China’s patent law [1]. Public comments on these measures are due by 25 October 2020.