Policies & Legislation

Anti-price gouging: legislation introduced in Senate while Maryland’s appeal is rejected

Home/Policies & Legislation | Posted 01/04/2019

Under current law in the US, pharmaceutical companies can raise prices of their products without justification. A 2017 Public Citizen survey revealed that only 14% of the world’s top 29 pharmaceutical companies were willing to limit annual price increases to less than 10%. In February 2019, US senators proposed legislation to reduce prescription drug price gouging, while Maryland’s appeal of a ruling that struck down its anti-price gouging regulation was rejected.

New safety requirements for EU medicines

Home/Policies & Legislation | Posted 15/03/2019

As of 9 February 2019, most prescription medicines and some over-the-counter medicines supplied in the European Union (EU) are legally obligated to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging.

Two more countries added to EU-US mutual recognition agreement

Home/Policies & Legislation | Posted 08/03/2019

The European Medicines Agency (EMA) announced on 11 February 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, Poland and Slovenia.

Australia plans reform of its generics authorization process

Home/Policies & Legislation | Posted 01/03/2019

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), announced on 7 February 2019 a public consultation into proposed improvements to its generics authorization process.

UK pharmacists gain powers to address drug shortages

Home/Policies & Legislation | Posted 22/02/2019

Pharmacists in the UK are gaining news powers to be able to dispense alternatives when there are drug shortages.

45 US states have passed biosimilar substitution laws

Home/Policies & Legislation | Posted 15/02/2019

Despite the fact that the US Food and Drug Administration (FDA) has yet to approve a biosimilar as interchangeable with its reference biological, many US states have been considering legislation on biosimilars substitution [1].

India tightens regulation on generics manufacturers

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

The pharmaceutical industry in India ranks third in the world in terms of volume and is the largest provider of generic medicines globally. However, concerns over the quality of generics manufacturing have affected utilization in India. This is demonstrated by poor sales in Jan Aushadhi outlets, which are government-run retail outlets providing generic medicines at an affordable price.

Australia’s TGA will keep same names for biologicals

Home/Policies & Legislation | Posted 01/02/2019

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has decided to keep the same names for biologicals.

Five more countries added to EU-US mutual recognition agreement

Home/Policies & Legislation | Posted 14/12/2018

The European Medicines Agency (EMA) announced on 29 November 2018 that the Mutual Recognition Agreement between the European Union and the US had been extended to include five additional EU Member States, Belgium, Denmark, Estonia, Finland and Latvia.

Patient, health and trade groups say USMCA will keep drug prices high

Home/Policies & Legislation | Posted 30/11/2018

Patient, healthcare and trade groups have warned that the North American Free Trade Agreement (NAFTA), now known as the US-Mexico-Canada Free Trade Agreement (USMCA) will keep American drug prices high.

FDA strengthens and modernizes inspections for sterile injectable drugs

Home/Policies & Legislation | Posted 23/11/2018

On 9 November 2018, the US Food and Drug Administration (FDA) announced that it was taking new steps to modernize its inspections programme with a new way of assessing, recording and reporting the data from surveillance and pre-approval inspections for sterile drug products.

Appeal by Australia’s watchdog against Pfizer ruling dismissed

Home/Policies & Legislation | Posted 16/11/2018

Australia’s High Court has rejected the nation’s competition watchdog’s efforts to revive an antitrust case accusing Pfizer of abusing its market power to maintain control of the Australian generics market for its cholesterol-lowering drug Lipitor (atorvastatin).

New Zealand to fund only biosimilar epoetin alfa

Home/Policies & Legislation | Posted 09/11/2018

New Zealand will stop funding the brand-name epoetin alfa biological Eprex and, in future, will only fund the biosimilar epoetin alfa Binocrit.

EU-US mutual recognition extended to include Portugal

Home/Policies & Legislation | Posted 02/11/2018

The European Medicines Agency (EMA) announced on 20 September 2018 that the Mutual Recognition Agreement between the European Union and the US had been extended to include one additional EU Member State, Portugal.

Australia encouraging biosimilars and mandating drug shortage reporting

Home/Policies & Legislation | Posted 19/10/2018

In an effort to address both the rising prices of medicines and the risk of drug shortages in Australia the country has introduced drivers to encourage the use of biosimilars and mandatory reporting of drug shortages.

EMA aims to improve the availability of medicines in Europe

Home/Policies & Legislation | Posted 12/10/2018

A European Union (EU) task force, which was set up by European regulators, has published its work programme for 2019/20 and announces a multi-stakeholder workshop.

Biosimilars no longer eligible for parallel processing in Australia

Home/Policies & Legislation | Posted 05/10/2018

Biosimilars will no longer be able to request parallel processing when submitting a biosimilar application for approval in Australia.

Mexico trade deal impacts biologicals exclusivity

Home/Policies & Legislation | Posted 21/09/2018

The US announced a new ‘understanding’ on trade with Mexico on 27 August 2018. The announcement comes as part of efforts to re-negotiate the North American Free Trade Agreement (NAFTA) between the US, Canada and Mexico, which first came into force in January 1994.

AbbVie ruled to pay nearly US$450 million for antitrust violations

Home/Policies & Legislation | Posted 14/09/2018

AbbVie and their partner firm Besins Healthcare have been ordered by the Federal Trade Commission (FTC) to pay US$448 million for preventing generics competition to their testosterone product Androgel. This is the largest amount ever seen in an FTC antitrust case.