New rules on clinical trials and other key changes in the Slovak pharmacy sector

By Katarína Pfeffer, Bibiana Mozoľová

12-2017

The rules for clinical trials on medicinal products for human use are to change early next year. There is currently a draft bill before the Slovak Government aimed at reflecting and implementing the EU Regulation on clinical trials on medicinal products for human use . In Slovakia, this implementation will be incorporated into the Act No. 362/2011 Coll. Medicinal Products and Medical Devices (the Act).

The Ministry of Health of the Slovak Republic is acting to implement the Regulation, which is to be implemented by each Member State, and is already working in close cooperation with the State Institute for Drug Control to enable this to happen.

As part of the new rules, there will be several changes to the work undertaken by the Ethical Committee for Clinical Trial of Drugs, which was appointed by the Ministry of Health to focus on the ethical review of clinical trials. The Committee's main aim will be considering following:

  • Clinical aspects of applications for the authorisation to conduct clinical trials of medicinal products;
  • Authorisation of a substantial modification in clinical trials, and
  • Addition of the Slovak Republic to a clinical trial authorised in other Member States submitted via an EU-wide clinical trial portal.

Fee increases for assessing the different types of applications for the authorisation of clinical trials are also proposed. New fees for authorisation of clinical trials will be in the range of EUR 3,050 up to EUR 9,100 and will depend on several factors, e.g., drugs for innovative therapy, the rapporteur Member State etc.

The draft bill also eliminates the European Commission's comment to project EU Pilot (2016) 8727 in which the Slovak republic was alerted to several issues relating to the implementation of Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE). The draft bill eliminates this alert. The EU Pilot also contains a comment on the correct definition of what constitutes a medical device in Directive 93/42 / EEC of the European Parliament of 14 June 1993 on medical devices. The bill contains the EU Pilot's recommended requirement that the medical device is intended for use by humans.

The draft bill also promotes other changes: it proposes the establishment of public pharmacies and pharmacy branches. Increasing the responsibilities of professional representatives who provide medical care in public and hospital pharmacies is also proposed. The responsibilities of these professional representatives will be further clarified (e.g., their responsibilities for managing orders, storing drugs, keeping relevant evidence etc.).

There is also a new definition of 'emergency pharmacy service' and how this service will be provided. In essence, it will be provided on working days (4 pm to 11 pm) and on non-working days (7 am to 11 pm).

The draft bill further specifies the SIDC's responsibilities, which include, inter alia, the following:

  • The SIDC may request from the registrant samples of human drugs, medical products or reference substance in the amount required for three complete analyses;
  • The SIDC will be entitled to request a written opinion in the event of any doubt as to the safety or scientific justification of a clinical trial conducted by the adjudicating entity or even by a direct examiner;
  • Increased obligations related to rapporteur Member States;
  • The SIDC will no longer be limited by the 90-day period when postponing registration of a human drug. Under the new rules, this period will be removed.

The proposed bill will burden the business sector in the field of clinical trials with increased administrative fees, and companies providing pharmaceutical care will be affected – i.e., holders of licences to provide pharmaceutical care in a public pharmacy or a branch, who will have to ensure that they are majority shareholders of the pharmacy.

The bill is currently still subject to the legislative process and therefore not yet in its final form. It is expected that it will enter into force over the next few years, with the first changes to become effective on 1 March 2018, and the remaining changes on 1 July 2019 and 1 July 2022.

 

Authors

Bibiana Mozolova

Bibiana Mozoľová

Associate
Czech Republic & Slovakia

Call me on: +421 232 332 800
Image of Katarina Bujnakova

Katarína Pfeffer

Associate
Czech Republic & Slovakia

Call me on: +421 232 332 800