Reports

Problematic pharma patent settlements decrease in the EU

Home/Reports | Posted 13/01/2012

A second round of European Commission (EC) monitoring concluded in early 2011. The main objectives of the monitoring exercise were to ‘better understand the use of these type of agreements in the EU and to identify those settlements that delay generic market entry to the detriment of the European consumer possibly in violation of European competition law’. The type of settlements the Commission was looking for were those limiting generic entry and at the same time foreseeing a value transfer from the originator to the generic company.

How originator companies delay generic medicines

Home/Reports | Posted 16/12/2011

Once a medicine marketed by the originator company is no longer protected by patents or other exclusive rights, generics companies can enter the market with a medicine that is equivalent, in terms of efficacy, safety, and quality, to the original. This lowers prices and enhances access to affordable treatments. The generic medicines are always cheaper than the originator brands. In addition, the prices of originator products after two years of generics competition are around 10% lower than at the time of generics entry [1], see Figure 1.

EU investigation tackles pay-for-delay

Home/Reports | Posted 09/12/2011

When the European Commission (EC) was created, one of the founding principles was that of free trade. There should be no barriers to trade within ‘the common market’ as it was called at the time. The Competition Commissioner has previously examined parallel importing in the pharmaceutical sector and has the power to impose large fines.

Generics will grab Parkinson’s disease market share

Home/Reports | Posted 10/11/2011

Overall sales for Parkinson’s disease drugs in seven major countries will decline slightly from US$2.7 billion in 2010 to US$2.6 billion in 2020 in France, Germany, Italy, Japan, Spain, the UK and US, according to a new report from research and advisory firm Decision Resources. The decline is attributed to key therapies losing patent protection and subsequent generics competition.

Pay-to-delay debate hits South Africa

Home/Reports | Posted 04/11/2011

A report issued in August 2011 by the US Federal Trade Commission (FTC), on the short and long-term effects of authorised generics has sparked a debate over how this affects generics in South Africa.

Overprescribing of drugs ‘chronic’ in Europe

Home/Reports | Posted 04/11/2011

Salzburg Medical University, Austria, is the latest body to report the ‘chronic’ overprescribing of drugs for the elderly in Europe. The study found that 36% of prescriptions given to patients with an average age of 82 years were unnecessary, while 30% of drugs prescribed were found to be inappropriate.

Clinical biosimilar data should be accessible to all

Home/Reports | Posted 21/10/2011

Calls are growing for biosimilar manufacturers to publish their data in the public domain, particular when developing versions of monoclonal antibodies (mAbs) that are associated with potential survival benefits [1-3].

The reference pricing system: a socio-economic analysis of the use of low cost medicines in Belgium

Home/Reports | Posted 09/09/2011

Medicines contribute to improving the health status of populations. A recent literature review concluded that medicines are among the most valuable forms of health care and are instrumental in treating various diseases more effectively [1]. Medicines are a major driver of the significant increase in life expectancy observed over the previous decades [2]. The Belgian system therefore tries to help people in socially disadvantaged groups access good quality medicines at affordable prices. This article asks how the system might be improved to better fulfil this objective.

Not only generics makers are well placed to move into biosimilars

Home/Reports | Posted 19/08/2011

The lucrative biologicals market already boasts five of the world’s top 10 bestselling medicines [1], and by 2015, IMS Health expects spending on biosimilars to exceed US$2 billion annually, or about 1% of total global spending on biologicals [2]. Although major generics players are well placed to tap into this lucrative market, it is not an exclusive club, and R & D companies also have opportunities [3].

Problematic patent settlements in EU on the decrease

Home/Reports | Posted 19/08/2011

The European Commission’s (EC) second monitoring exercise of patent settlements in the pharmaceutical sector has shown a continuing decline of potentially problematic settlements under EU antitrust rules.