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Policies & Legislation

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India announces free drugs for all―generics only

Home/Policies & Legislation | Posted 06/07/2012

In a radical move, the Indian government has pledged to provide free drugs for all from October 2012, with a focus on generic medications as a more affordable option than brand-name drugs. The announcement, from Prime Minister Manmohan Singh, follows concerns about rising out-of-pocket expenditure on health care, and the need to contain overall drugs expenditure in India.

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Risk management is forgotten as FDA reform struggles through Congress

Home/Policies & Legislation | Posted 22/06/2012

FDA’s authority on new drug approvals and post-marketing reports was last updated in 2007, when Congress passed the FDA Amendments Act (FDAAA), and this time the deadline is 30 September 2012 for the Prescription Drug User Fee Act (PDUFA), made law in 1992. It is generally accepted that FDA should also amend the Risk Evaluation and Mitigation Strategies or REMS programmes. This is important for generics, since as part of REMS originator companies have to provide samples of their products.

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Squabbles continue over Obama health bill

Home/Policies & Legislation | Posted 18/06/2012

In May and June 2009 the White House reportedly made ‘behind closed doors’ deals with the pharmaceutical industry to win support for the Affordable Care Act. The House Energy and Commerce Committee, which has a Republican majority, released emails from the industry lobbying group. In response, the White House called the release of the emails ‘a nakedly political, taxpayer-funded crusade to hurt the president’s re-election campaign.’

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EMA opens up access to reports on suspected drug side effects

Home/Policies & Legislation | Posted 08/06/2012

In its commitment to transparency, EMA, on 31 May 2012, opened up access to reports on suspected drug side effects. The database contains reports on around 650 medications and active ingredients, including vaccines. Each entry covers a different drug, with aggregated information on suspected but not proven side effects, also known as adverse drug reactions. The database currently holds information on products that have been authorised within the European Economic Area (EEA) via the centralised authorisation procedure which are managed by EMA. Nationally authorised products will feature in a second wave of access in 2013.

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US Senator calls for prizes not patents for drug discovery

Home/Policies & Legislation | Posted 25/05/2012

A radical idea has been proposed by a US Senator calling for patents on drugs to be scrapped and instead an annual prize fund set up, which would reward the discovery of new treatments. These treatments would then, due to competition, become available at the lowest possible price.

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Australia cuts prices of 13 more drugs on PBS

Home/Policies & Legislation | Posted 11/05/2012

Thirteen medicines on the Pharmaceutical Benefits Scheme (PBS), accounting for more than 200 brands, will take price cuts of between 11% and 77% from 1 August 2012 as part of the ongoing price disclosure system agreed between Medicines Australia and the Australian Government.

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Bill introduced to allow generics to change labelling

Home/Policies & Legislation | Posted 27/04/2012

A new bill aims to address a recent Supreme Court decision that threatens to undermine the safety of consumers taking generic drugs.

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PhRMA speaks out against compulsory licensing in India

Home/Policies & Legislation | Posted 13/04/2012

The decision by the Indian government to issue a compulsory licence for the first time has led the research-based pharmaceutical industry to raise concerns regarding research and innovation.

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Obama healthcare budget cuts

Home/Policies & Legislation | Posted 24/02/2012

US President Barack Obama has announced proposals for fiscal year 2013 which aim to cut the US deficit by US$4 trillion over the next decade. However, drugmakers have reacted with disappointment to proposed cuts to health care.

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EMA a step closer to implementing new pharmacovigilance rules

Home/Policies & Legislation | Posted 10/02/2012

In an attempt to enable better protection of public health, new pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010 [1]. It is now the job of EMA to implement this new legislation, which must be in place by July 2012.

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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.

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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.

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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.

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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.

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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].

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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.

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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.

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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.

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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.

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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.