Spanje: voorstel prijsregulering medicinale product niet conform subsidiariteitsbeginsel

Reasoned opinion by the Spanish Congress of Deputies and by the Spanish Senate on the amended proposal for a Directive of the European Parliament and of the Council on the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems (COM(2013)0168 – C7-0076/2013 – 2012/0035(COD))
13. However, other parts of the proposal impose a considerable burden on national authorities as regards the exercise of their competences in the health field. Possibly the best example is Article 11, which limits Member States’ capacity to adopt measures to control or promote the prescription of specific medicinal products.
14. At this time of economic crisis, measures to limit spending, cost-effectiveness considerations and budgetary implications become increasingly important. Interference in Member State policies relating to the pricing of medicinal products and their inclusion in public health insurance systems could thus be seen as one step too far.

15. The proposal also fails to explain sufficiently why Member States would be unable, with a more flexible regulatory framework, to achieve the internal market development objectives pursued by the Commission. Whilst there are some serious shortcomings in the way Directive 89/105/EEC is implemented, given that it entered into force almost 25 years ago and does not reflect the current reality in the pharmaceutical market, the full development of the internal market could be achieved in this field by means of a directive which encroaches less on national competences.
16. In trying to strike the necessary balance between the safeguarding and development of the internal market, on the one hand, and the right of Member States to define their own health policies, on the other, this proposal encroaches too much on the latter. By restricting to such an extent Member States' capacity to price medicinal products and to decide whether to include them in public health insurance systems, the proposal infringes on national competences in the field, and thus breaches the principle of subsidiarity.

For the reasons stated above the Joint Committee on European Affairs considers that the amended proposal for a Directive of the European Parliament and of the Council on the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems does not comply with the principle of subsidiarity as laid down in the current Treaty on European Union. This reasoned opinion will be forwarded to the European Parliament, the Council and the European Commission, within the framework of political dialogue between the national parliaments and the institutions of the European Union.