Policies & Legislation

Australia’s biggest-ever generics price cuts coming in April 2012

Home/Policies & Legislation | Posted 27/01/2012

On 1 April 2012, the prices of 75 medicines supplied through Australia’s Pharmaceutical Benefits Scheme (PBS) will be reduced by an average of 28.7%, saving the government an estimated Australian dollars (A$) 1.9 billion (Euros 1.5 billion) over four years.

Landmark EU ruling on supplementary protection certificates

Home/Policies & Legislation | Posted 02/12/2011

Pharmaceutical industry groups have broadly welcomed a landmark ruling by the Court of Justice of the European Union (CJEU) clarifying the rules on extended patent protection for multi-disease products. It clarifies the scope of protection afforded by supplementary protection certificates (SPCs) and the circumstances under which they can be granted. The ruling answers questions referred by the Court of Appeal of England and Wales in the cases of Medeva (a company bought by Celltech that, in turn, was taken over by Belgium’s UCB in 2004) and Georgetown University, USA.

Twenty per cent of generic drug user fees to come from API manufacturers

Home/Policies & Legislation | Posted 02/12/2011

In a presentation by the European Fine Chemicals Group (EFCG) at CPhI Worldwide, Frankfurt, Germany, on 25 October 2011, data was presented showing that generic active pharmaceutical ingredient (API) manufacturers are expected to contribute only a small proportion towards generic drug user fees.

FAIR Generics Act could remove 180-day exclusivity

Home/Policies & Legislation | Posted 25/11/2011

On 16 November 2011, US Senators Mr Jeff Bingaman, Mr David Vitter, Mr Sherrod Brown and Mr Jeff Merkley introduced a bill in the Senate that would remove the 180-day exclusivity period for generics applicants.

Bill to outlaw pay-to-delay moves ahead slowly

Home/Policies & Legislation | Posted 18/11/2011

A bill banning pay-to-delay, the practice by which originator and generics firms share the profit from drugs coming off patent rather than moving quickly to price reduction, is progressing slowly through the US legislature. It has made its way through the Senate Judiciary Committee but has not yet been approved by the Senate [1]. President Barack Obama has joined in, with a pay-to-delay ban in his 2012 budget proposal [2].

2013’s biggest patent expiries

Home/Policies & Legislation | Posted 04/11/2011

2013 looks set to be another great year for generics and biosimilars, with once again some major blockbuster drugs losing patent protection.

New stability testing rules for generics

Home/Policies & Legislation | Posted 28/10/2011

Both EMA and FDA are increasing their requirements for stability testing, especially for generic drugs. These changes could significantly increase the length of time required to gain regulatory approval and increase costs for generics manufacturers to get their drugs onto the market.

Australia and New Zealand outline plans for joint regulatory agency

Home/Policies & Legislation | Posted 30/09/2011

The Australian and New Zealand governments have agreed to proceed with a joint scheme for regulation of therapeutic goods, i.e. medicines, medical devices, etc. The creation of a joint regulatory scheme across both countries will safeguard public health and safety, while encouraging economic integration and benefitting industry in both countries.

Practical guidance on new pharmacovigilance legislation

Home/Policies & Legislation | Posted 30/09/2011

New pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010. EMA is the regulatory body responsible for implementing much of the new legislation and is developing a framework for compliance and delivery of key requirements. The legislation will be effective from July 2012.

China cuts drug prices for the second time in 2011

Home/Policies & Legislation | Posted 23/09/2011

China has, for the second time this year, cut the price of drugs. The maximum retail price of 82 different pharmaceutical drug types has been lowered by an average 14% in a move to reduce patient’s medical bills.

US President approves patent reform

Home/Policies & Legislation | Posted 23/09/2011

On 16 September 2011, US President Barack Obama signed into law a patent-reform bill that has been backed by brand-name drugmakers but opposed by generics companies.

US Senate approves patent reform

Home/Policies & Legislation | Posted 16/09/2011

On 8 September 2011, the US Senate passed a patent-reform bill that has been backed by brand-name drugmakers but opposed by generic companies.

European Commission publishes new rules on falsified medicines

Home/Policies & Legislation | Posted 26/08/2011

A new directive on falsified medicines was published in the Official Journal of the European Union 1 July 2011.

Effect of patent filing and initiation of clinical trials on market exclusivity

Home/Policies & Legislation | Posted 05/08/2011

The effect of the date of patent filing and the initiation of clinical trials can influence the expected duration of marketing exclusivity for originator companies.

Concerns of patent filing and approval date on market exclusivity

Home/Policies & Legislation | Posted 29/07/2011

An understanding of the relationship between the date of patent filing and the marketing approval date on the expected duration of marketing exclusivity is critical for originator companies to maximise this period of exclusivity in order to recuperate their research and development costs before the advent of generic competition. Recent research has modelled the available duration of US market exclusivity for originator drugs at various times after the initial patent filing [1].

Patent filing and market exclusivity

Home/Policies & Legislation | Posted 08/07/2011

The relationship between patent filing dates and the marketing authorisation date can change the duration of marketing exclusivity an originator pharmaceutical product can expect to enjoy [1].

Italy and Spain threaten legal action over EU patent

Home/Policies & Legislation | Posted 01/07/2011

EU ministers have adopted a general approach to the two Commission proposals that provide for a European patent to protect inventions in the same way in all participating member countries. However, Italy and Spain are objecting to the ‘enhanced cooperation’ procedure and threatening legal action.