Policies & Legislation
India plans further cuts to drug prices
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
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
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
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?
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
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
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
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
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
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.’
