Policies & Legislation

India patent laws under close scrutiny

Home/Policies & Legislation | Posted 09/11/2012

The international pharmaceuticals community is watching closely as Pfizer appeals against a decision to revoke its patent on Sutent (sunitinib).

Generic drug user fees come into effect

Home/Policies & Legislation | Posted 19/10/2012

Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (GDUFA) was approved by the US Congress’s House Energy and Commerce Committee on 21 September 2012. FDA User Fee Corrections Act of 2012 amends the FDA Act to address certain issues raised by language included in the GDUFA.

MSF launches online ‘Patent Opposition Database’

Home/Policies & Legislation | Posted 26/10/2012

The international medical humanitarian organisation Doctors Without Borders/Médecins Sans Frontières (MSF) has launched an online resource to help civil society and patient groups in developing countries challenge unwarranted drug patents.

India plans further cuts to drug prices

Home/Policies & Legislation | Posted 12/10/2012

The Indian government has announced plans to further extend price cuts on both generic and brand-name drugs in order to try to improve access to affordable medicines in the country.

Generics substitution: Ireland’s plan for reference pricing

Home/Policies & Legislation | Posted 21/09/2012

A bill that will be debated this autumn seeks to introduce generics substitution and reference pricing for medicines and medical and surgical appliances in Ireland.

India’s patent laws coming under repeated challenges

Home/Policies & Legislation | Posted 14/09/2012

India’s patent laws are being challenged by Big Pharma. Novartis is challenging India for denying the pharma giant a patent for Glivec (imatinib mesylate), its blockbuster cancer drug. While Bayer is challenging the Indian Government’s decision to grant a compulsory licence on its cancer drug Nexavar (sorafenib).

Malaysia objects to patent terms in free trade agreement

Home/Policies & Legislation | Posted 17/08/2012

Once again, the issue of patent protection and the periods of exclusivity given to originator pharmaceuticals (both small molecule and biological) has raised its ugly head in the negotiations for the Trans-Pacific Partnership (TPP) Free Trade Agreement. This time, the Malaysian Health Minister, Dr Datuk Seri Liow Tiong Lai, has spoken out against terms in the agreement which seek to extend the patent periods of medicines produced by foreign companies.

Is the end in sight for pay-for-delay?

Home/Policies & Legislation | Posted 17/08/2012

A Federal appeals court ruling may bring the US pharmaceutical industry before the Supreme Court. Will this put an end to a practice that is increasingly viewed as anticompetitive?

Rising tensions over drug pricing and patenting in India

Home/Policies & Legislation | Posted 10/08/2012

New developments in pricing and regulations of drugs in India mean that tensions are likely to mount over the coming months between international pharmaceutical interests and healthcare providers who are trying to improve access to affordable medicines.

Australia moves towards pricing policy for biosimilars

Home/Policies & Legislation | Posted 03/08/2012

The Australian Pharmaceuticals Industry Council (PIC) has agreed to a broad strategy for the pricing of biosimilars so as to encourage the development and entry of biosimilars into the market place.

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.

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.

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.’

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.

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.

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.

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.

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.

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.

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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