Life Sciences 2Q/2024
Lukáš Michálik
Klaudia Popélyová
Dear Reader,
we are pleased to present to you a quarterly overview of news in the field of Life Sciences in Slovakia and the European Union. In this issue, we will briefly introduce you to the changes or legislative amendments that have entered into force or are still in the process of approval and relate to drug policy, health care or regulation of related areas that affect the Life Sciences field. We conclude (as is already customary) with an interesting news from M&A in Life Sciences.
Strikingly inconspicuous amendment to the NIHO Act
On 12.06.2024, the National Council of the Slovak Republic approved an amendment to Act No. 581/2004 Coll. on Health Insurance Companies, Supervision of Health Care and on Amendments and Additions to Certain Acts, as amended, within the framework of which an amendment was submitted in the second reading, which also proposed an amendment to Act No. 358/2021 Coll. on the National Institute for Value and Technology in Health Care and on Amendments and Additions to Certain Acts, as amended, by a so-called addendum.
This wide-ranging amendment was approved in full. The amendment to the NIHO Act contains numerous changes in relation to the filling of the post of director of NIHO, e.g. changing the educational qualifications of the candidate for the post of the director of NIHO.
The most significant change, however, is the modification of the “roles of the Institute” by deleting the condition of the significance of the impact on public health insurance funds.
In principle, this means that NIHO’s role has been extended to the evaluation of any health technology except generic medicines and biosimilars.
For more information:
Amendment of the Regulation concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
In June 2024, a Commission delegated regulation amending the regulation on the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products was adopted. The amendment of the Regulation is justified by the Commission based on practical experience with the application of the Regulation and aims to create a simpler, clearer and more flexible legal framework, while guaranteeing the same level of protection of public health.
The procedures in the Regulation shall be regulated without departing from the general principles on which those procedures are based.
The amendment should enter into force on 01 January 2025.
For more information:
Preparation of pharmacoeconomic analyses is changing
After 13 years since the adoption of Decree No. 422/2011 Coll. on the details of pharmacoeconomic analysis of medicinal products, the Ministry of Health of the Slovak Republic has introduced a new methodological guide to the Decree.
It aims to:
- to assist in the preparation of pharmacoeconomic analysis through clear procedures;
- increase transparency; and
- standardise the quality of the documentation submitted.
In addition, the guide enhances clarity on various aspects, such as defining comparators for the drugs being evaluated and describing procedures for specific scenarios, such as statistically insignificant benefits or the inclusion of newer data.
Perhaps the most important aspect of the guide, however, lies in its detailed section on the cost-effectiveness of medicines. It explains the various inputs that are key to determining the cost-effectiveness of the health technologies evaluated, which is a key criterion for the inclusion of medicines in the list of categorised medicines
For more information:
EMA continues to strengthen supply chains for critical medicines in the EU
The European Medicines Agency (EMA) has published a list of recommendations aimed at strengthening supply chains for critical medicines in the European Union.
The EMA’s Executive Steering Group on Shortage Medicines and Medicines Safety (MSSG) is responsible for proposing measures to address weaknesses in the supply chain and strengthen the security of supply of these critical medicines.
The MSSG has made recommendations that will aim to strengthen supply chains for critical medicines. The specific recommendations of the MSSG will be imposed on a situation-by-situation basis and may include (but are not limited to):
- increase production capacity;
- diversification of suppliers in the supply chain;
- monitoring supply and demand;
- maintaining safety stocks;
- introducing joint procurement mechanisms;
- imposing other regulatory obligations;
- providing regulatory support;
- offering investment incentives.
If a recommendation is imposed, it should be communicated to the relevant registration holders via i-SPOC within approximately one week of publication.
For more information:
Amendment to the Act on Advertisement
From July 2024, a new comprehensive consumer protection regulation will apply in Slovakia. This legislation applies to B2C relations, but the law also introduces amendments to other legislation after the Consumer Protection Act.
One of these regulations is the Act on Advertisement, with changes to the penalties for breaches of individual obligations under the Act on Advertisement.
The supervision of compliance with the Act on Advertisement in relation to medicinal products is still carried out by SIDC. At the same time, self-regulation as regards the dissemination of advertising by publication or through an agency service is encouraged.
Regarding sanctions, there has been a significant increase and repeated imposition of sanctions. A higher fine is foreseen for repeated (identical) infringements of the Act on Advertisement.
The amendment to the Act on Advertisement is effective from 1 July, 2024.
For more information:
The amended Act on Advertisement
Early-stage drug development and AI tool
AI has a high potential to significantly change the landscape of new drug development.
Australian researchers led by Monash University have invented a new artificial intelligence tool (AI) that stands poised to transform virtual screening in the early stages of drug development and improve scientists’ ability to identify potential new drugs.
For more information:
AI in the early stages of drug development
Will we pay extra for priority examination?
Amendment to Act No. 577/2004 Coll. on the scope of health care reimbursed under public health insurance and on reimbursement for services related to the provision of health care was approved in the first reading and advanced to the second reading.
The subject of the amendment is the priority provision of outpatient care during designated office hours.
The amendment does not address the amount of the fees themselves, it only states that the amount of the reimbursement will be approved by the self-governing region according to the place of operation of the health care facility.
Therefore, that means that there may be a variations in the introduction of charges for priority provision of outpatient care, depending on which self-governing region the patient is the priority provision of the outpatient care provided in.
For more information:
EU Pharmaceutical Package :: What’s next?
The European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) adopts a new directive and regulation.
Several key proposals have been put forward to make the EU research environment and market more attractive:
- extension of the basic regulatory data protection to 7.5 years.
- introduction of a market protection period of 2 years, with an additional year to secure approval of significant new indications.
- offering orphan drug market exclusivity for 9 years, with the possibility of a 2-year extension to address high unmet medical needs, etc.
- introduction of a requirement for companies to submit a pricing and reimbursement (P&R) request to Member States on request.
Members of the European Parliament have recently endorsed and supported the revisions to the Commission’s proposals:
- amendments to data protection regulations, market exclusivity for orphan medicines and antimicrobial resistance (AMR).
- potential extension of the EU system for notification of access to medicines to include broader pricing considerations within 5 years. Support for comparative clinical trials.
- possible authorisation of cross-border exchange of innovative therapy medicinal products (ATMPs) prepared under hospital exemption in cases of medical necessity.
For more information:
Press release: EU Pharmaceutical policy
Merck acquires EyeBio
According to a May 2024 press release, Merck will acquire EyeBio, a privately held ophthalmology company.
Based on the information available, Merck will acquire EyeBio through its subsidiary.
EyeBio is working to develop clinical and preclinical products to prevent and treat vision loss associated with fluid leakage from retinal vessels, a known risk factor for retinal diseases. Given the positive results, the developed product is anticipated to advance into a pivotal phase study to investigate the treatment of patients with DME in the second half of 2024.
For more information: