EU Pharmaceutical Law: Voucher system may be open to abuse

Currently - in addition to 20 years of patent protection - the market monopoly in the EU is provided by 8 years of data exclusivity protection, followed by a 2-year period of market exclusivity that can be extended for another year (the so-called 8+2+1). This protection is the longest in the world. By comparison, the system used in the U.S., off-patent, provides for a standard 5-year period of data exclusivity. Meanwhile, in the proposed changes to the law, the European Commission plans to extend these exclusivities by up to 2 years, i.e. to a maximum of 13 years, through, among other things, the possibility of acquiring a special Voucher.

According to the National Drug Manufacture...