Etude de cas Novartis

The pharmaceutical industry is a top performing high technology sector and currently sells a variety of products and therapeutic healthcare packages that include drugs, diagnostic tests and devices as well as a wide range patient support services. The pharmaceutical industry is the top ranking sector with the highest share in R&D investment of the 36 European sectors: 19.2% (See Exhibit 1) of the total worldwide R&D business. The pharmaceutical industry is also the sector with the highest ratio of R&D investment to net sales.

The cost of researching and developing a new chemical or biological entity was estimated at ? 1,059 million in 20061. On average, only one or two of every 10,000 substances synthesized will successfully pass all the stages to become marketable medicines and the attrition rate of compounds is increasing.

In 2007, the pharmaceutical industry invested about ? 26,000 million in R&D in Europe. In comparison with the North American and Asian regions, Europe is still seen as a less attractive R&D investment location in terms of market size and incentives for the creation of new innovative biotech companies.

Innovation is at the heart of the challenge faced by the pharmaceutical industry with a large cost of innovation both in terms of investments and time for making a new product ready for the market. Innovation is usually classified into three levels, according to the added therapeutic value and benefits for patients: incremental benefits, this is the case with new formulations and new dosage forms; stepwise innovation different molecules of a same family offering different properties such as indication, tolerability and drug metabolism; breakthrough innovation with a genuine new approach to the disease or a new chemical entity.

The European law ensures a patent protection of twenty years for pharmaceutical products. However, due to the long duration of clinical trials, the effective duration of patent-protection after marketing a drug is around ten years. This European regulation is applied in Spain to drugs marketed after October 1992. Prior to this date, the protection was restricted to the manufacturing process and copies were flourishing. A recent European law (Bolar clause) allows pharmacological and clinical studies before the end of patent protection and generic drugs can be launched as soon as the patent ends.

Patent expiration most often means that the revenue produced by a drug has finished. According to the European Commission, in the period between 2000 and 2007, the initial price of generics entering the market was on average 25 per cent lower than the price set by originator companies prior to loss of exclusivity. Additionally, prices for both drugs fall over time starting from the point of generic entry. The average delay during this period was found to be "about seven months" although for the most valuable products this figure drops to four months. Biologic medicines are often complicated by various additional issues and the patent is extended to include particular methods of industrial protection.

The European Medicines Agency is the European Union body responsible for coordinating the existing scientific resources put at its disposal by Member States for evaluation, supervision and pharma-covigilance of medicinal products. National drug authorities require registration of any drug in order to make it available to patients.