Acting effectively in proceedings before regulatory bodies

 

 

Provisions of the CAP impose specific obligations on public authorities and give the parties to the proceedings a number of rights which well used can facilitate the proceedings and increase chances of positive and prompt resolution of the case.

 

One of the important rights which is sometimes forgotten by pharmaceutical companies being parties to administrative proceedings is the possibility of presenting evidence in order to justify their demands. Under Article 75 § 1 of the CAP, anything that may contribute to the clarification of a case and is not contrary to the provisions of law, may be presented as evidence. To give an example, the evidence presented might be a witness testimony, documents and even visual examinations of places or objects. Although in administrative proceedings, the burden of gathering evidence rests on public authorities the party concerned presenting appropriate evidence may bring forward the issuing of a decision and increase the chances of a resolution of the case in line with its demands.

 

If a party does not agree with the decision issued by the Minister of Health or the Main Pharmaceutical Inspector, it is entitled to have its case decided upon once again by filing a motion for a repeated resolution of the case. If in the party’s opinion the decision issued in the second instance also infringes the law, an appeal against the decision can be filed to the administrative court. Even though court judgments are binding only in the case in which they were issued, they may in practice influence the stand of administrative bodies in future cases.

 

One of the serious problems of proceedings before regulatory bodies in Poland is their tardiness in issuing decisions. Notwithstanding the fact that the provisions establish specific time periods for granting e.g. marketing authorization (MA) or making post-authorisation amendments to the MA, in practice the decisions in question are often not issued within the statutory time limits. In such cases the applicant is entitled to summon the Minister of Health to remove the violation of law by finally issuing a decision. If there is no response within 60 days, there arises a possibility of lodging a complaint against the inactivity of the Minister to the administrative court. Additionally, if any damage is incurred, it is also possible to claim damages before a civil court.

What if provisions of the Pharmaceutical Law do not specify the period of time in which a particular case should be decided? In such cases, again the rules set out in the CAP shall apply which require that public authorities resolve the case immediately or within one month if explanatory proceedings are required. Should the case be complex, it should be decided in the maximum time of two months. The maximum two month period may apply, for example, to the Minister of Health's issuing of a decision granting an exemption from the application of a sunset clause provision. This is because Article 33a sec. 2 of the Pharmaceutical Law does not indicate any particular time limit for the settlement of such a case and the issue of such an exemption will usually be complex.