Competition rules and liberalization of activities in the pharmaceutical sector

Recently, the CNC has issued its report on the Draft Royal Decree on Distribution of Medicinal Products for Human Use. The publication of this report coincides in time with the completion of the Draft Royal Decree on financing and pricing of medicinal products and with the appearance of news about the reopening of the debate regarding competition in the sector of pharmacy offices. It is obvious that competition rules have a more than relevant impact on the sector.

The reasons of this coincidence are not to be sought in hidden interests. For several years now, any draft legislation of the Government must be accompanied by a report on the impact that the regulation might have on competition in the market. It is true that these reports are rather scant, and that on many occasions their authors confine themselves to ticking a box on a form, marking that the draft has no impact at all, but in recent years, and fortunately so, the CNC is complying with its advisory tasks in the field in a particularly intensive and transparent manner. Not in vain Law 15/2007 attributes the CNC the authority to act as an advisory body in these matters.

This explains the fact that the CNC reminded the Government that setting limits on the prices for non-reimbursed medicinal products would demand an “extremely rigorous justification… of its necessity and proportionality”. What is missing in the Report that the CNC has prepared on the draft Royal Decree on distribution is a more refined reflection on the provisions regarding the duty to supply and the obligations that might be imposed on pharmaceutical companies in this field. This silence is only apparent. In its previous Report on the amendment of Law 29/2006, the CNC pronounced itself very clearly on these matters. In such report, when referring to how some of the infringements of the Law are planned to be defined, the CNC defends a draft that would avoid interpretations which would ultimately have an impact on decisions regarding the commercial policy of distributors, in restriction of their freedom to trade, and which would additionally create legal uncertainty. These observations deserve to be taken into account.

Finally, we must not forget that the rules of Directive 2006/123 and of Law 17/2009, which point out that one of the objectives of all public administrations must be to simplify the administrative proceedings required in order to obtain an authorization, are applicable to all regulations governing the granting of administrative authorizations, without any reservations.

The same rules establish also that that the procedure to be set in order to obtain or maintain an authorization must be suitable for securing the attainment of the objective pursued, that is the public health protection, and must not go beyond what is necessary to attain that objective. Furthermore, it must be replaced by other less restrictive measures which will allow obtaining the same result if such measures exist.