Masterarbeit
A comparative study of generic medicinal products in Europe ***
Leonor Enes (2003)
Generic medicinal products play an important role on the pharmaceutical market and on the national health system. They are extensively regulated both at European and at national level. Throughout this master-thesis the legislation on generics is described and evaluated. First in Europe and afterwards in Germany and Portugal which are the Member States here studied.
The first part of the thesis analyses how generics are defined and regulated in Europe by the Directive 2001/83/EC and how the European legislation is transposed at national level. Both in Germany and in Portugal the law presents different texts but it has a similar content. In practice, there was no relevant difference observed. Therefore, it can be concluded that there is an European harmonization on this field.
The second part of the work focus price and reimbursement systems. Price and reimbursement are intentionally poorly legislated at European level in order to allow national governments a high degree of freedom to legislate on these areas. On the opposite, price and reimbursement are extremely well regulated at national level. The national legislation of the two countries was studied. Germany belongs to the group of countries with a long and wide generic experience and Portugal has just made its first steps in the generic market. They are very good examples of how extremely different systems can co-exist in Europe. In Germany no price or reimbursement approval is required. The pharmaceutical entrepreneur is free to define its prices. The drug expenditure is controlled by reference prices, co-payment and prescription limitations. In Portugal the control on costs is made directly with compulsory price and reimbursement approval.
Concerning the new generic legislation on pricing and substitution systems, there is a visible similarity between the recently adopted politics by both governments. The German substitution system AABG (in force since February 2002) and the Portuguese Reference Price (in force since last March).
In Germany half of the medical prescriptions are from generic medicinal products and the generic medicinal products are for long implemented. In Portugal at the beginning of this year the generic market was almost insignificant (about 1%). Within the first month of implementation of the new law the generic market grew about 5%. These numbers show the increase of the generic market in Portugal.
The third and last part of the work analysis the current situation of the Review 2001. The Review 2001 consists on a very complete reform-package to revise the European pharmaceutical legislation as a whole. The legislative procedure started in November 2001 when the Commission submitted its proposal to the European Parliament and to the European Council of Ministers. The proposal concerning generic medicinal products concerns basically Article 10. It provides definition of generic medicinal product, harmonizes data protection and introduces "Bolar" type provisions. The First reading at the European Parliament took place in October 2002. The amended proposals for amending the Directive 2001/83/EC and the Regulation on Community procedures were already published by the Commission, respectively in April 2003 and December 2002.
A very important point that constitutes one of the basic concerns of the legislators is to find a balance between promoting innovation and ensuring competition. Therefore, the discussion will continue at the second reading at the European Parliament planned for next December. It seems that the Review 2001 is coming to an end and hopefully this ambitious and very important reform-package will be completed before the EU enlargement next year.
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