Slovenian Presidency of the Council of the EU 2021

106TH THE Heads of Medicines Agencies (HMA) MEETING

On 23 and 24 November 2021, the 106th regular meeting of the directors of the Heads of Medicines Agencies (HMA) took place in Brdo pri Kranju. Due to the epidemiological situation, the meeting was organised in a virtual format.

At the beginning of the first day, the Chair, Momir Radulović, conveyed a message from the Minister of Health of the Republic of Slovenia, Janez Poklukar, who wished the participants an efficient and successful meeting.

In addition to the regular updates from HMA Management Group (HMA MG), European Medicines Agency (EMA), European Commission (EC) and others, the participants discussed the revision of the EMA Fees Regulation, implementation of the new veterinary regulation and one of the requirements of the veterinary regulation which is delivery of the new database on veterinary medicinal products (UPD). UPD will serve as a single source of information on all authorised veterinary medicines and their availability in European Member States.

Under the JAZMP focus, special attention was given to medical devices. Discussion prioritised the structural challenges and perspectives on the future long-term governance and coordination of the medical devices regulatory system in Europe, short- and medium-term priorities and continued challenge in effective coordination on EU-level safety issues relating to medical devices. Reflections on ways to improve cooperation and a coordinated response capacity at European level were also highlighted.

The first part of the second day was dedicated on the state of play in the preparation of the Clinical Trials Regulation and the EU Clinical Trials Promotion Initiative (ACT EU). The Clinical Trials session ended with the endorsement of the new mandate of the Clinical Trials Coordination Group (CTFG). This transformation will allow a high-level outline of the EU environment, making it more friendly for innovative research and set it as an attractive place to conduct clinical trials.

SI The Presidency presented the final text on the new EMA mandate agreed in October following the negotiations on the legislative proposal. The participants also took note on the progress report of the “Repurposing pilot” project, which could enable the use of new indications of already established medicinal products, and the “Agile transformation progress report”, which establishes a new way of managing and controlling information technologies within the European regulatory network.

Meeting attended by approximately 90 participants ended with an information from the upcoming French Presidency.

Clinical Trials Facilitation and Coordination Group Plenary meeting

As part of Slovenian Presidency of the Council of the EU, the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) on 4 and 5 of November hosted the plenary meeting of the Clinical Trials Facilitation and Coordination Group (CTFG).

The group members were greeted by the director of JAZMP, Momir Radulović, on the first day of the meeting. In his address, he emphasised the need for international cooperation to improve the supply of safe and effective medicines in the EU.

On the first day of the meeting, CTFG members were informed about the developments from other meetings and possible cooperation on new trends in clinical trials:

  • ETF (EMA Task Force) – ETF member Ann Marie Janson Lang presented the progress of marketing authorization applications for covid-19 therapeutics and vaccines.
  • ACRO (Association of Clinical Research Organizations): ACRO experts strive to develop tools and methods and share them with regulators, sponsors, and stakeholders to support and accelerate the adoption of decentralized clinical trials.
  • EFPIA (European Federation of Pharmaceutical Industries and Associations) – EFPIA has expressed the intention to shift the design of complex clinical trial protocols from drug-centric to patient-centric.
  • EU-PEARL (EU Patient-Clinical Clinical Platforms) – The consortium aims to develop new methods, tools and frameworks for creating new infrastructure to enable patient-centric testing through an integrated system involving pharmaceutical companies, non-profit products developers and health care providers.

On the second day, the CTFG focused on the regulatory aspects of safety monitoring during multi-national clinical trials. The Best Practice Guidelines on safety assessment and assessment report preparation under the new Clinical Trials Regulation were presented and discussed. The group learned about the current status of the CTIS portal (Clinical Trials Information System).

The CTFG also devoted some time to discuss the joint actions within the EU4Health project, in particular, the joint action for expedited assessment of COVID-19 therapeutics clinical trials and the joint action on safety assessment cooperation.

30th Working Group of Enforcement Officers (WGEO) meeting

Location: due to pandemic situation virtual format has been used.

Participants: 69 in total, from 26 EU countries and 4 observers (Israel – Israel Ministry of Health, Russia – Roszdravnadzor, Switzerland – Swissmedic and USA – FDA).

In the first part of the meeting, Drug Agency representatives from host country, Slovenia, presented local system on combating counterfeit medicines. Three topics covered: surveillance collaboration of Slovene drug agency, JAZMP with Police and Customs, experience with Safety Features and case presentation of counterfeit medicines which was given by inspector of Criminal Police Directorat.

Further topics covered Irish experience with ivermectin, Covid -19 related bordeline products and specific problems of counterfeiting in context of pandemy, ghostshipping of pharmaceuticals and case of dangerous cannabinoid product containing rat poison.

In afternoon veterinary group met separate to discuss Art. 106 of Regulation (EU) 2019/6.

Members of the WGEO Management Committee (MC) were very positive about the meeting hosted by SI. They emphasised the very professional and competent preparation and implementation and thanked the Slovenian delegates, especially JAZMP as the organising authority.

Committee for Medicinal Products for Veterinary Use (CVMP) and Coordination group for Mutual recognition and Decentralised procedures – veterinary (CMDv) meeting

During the Slovenian presidency of the council of the EU, the Committee for Medicinal Products for Veterinary Use (CVMP) and Coordination group for Mutual recognition and Decentralised procedures – veterinary (CMDv) virtual meetings were held on the 13th and 14th October 2021.

The director of the Agency for medicinal products and medical devices of the Republic of Slovenia (JAZMP) Momir Radulović welcomed the participants and opened the meeting mentioning the goals of the Slovenian presidency of the council of the EU.

The morning session of the CVMP meeting addressed the environmental risk assessment of the ectoparasiticide pet veterinary medicinal products in Europe. An update of the document discussing the environmental risk assessment of the ectoparasiticides used in companion animals (reflection paper EMA/CVMP/ERA/31905/2021), the data collection and analysis challenges (with regards to the production and uptake of these veterinary medicinal products), potential routes of environmental exposure, identified knowledge gaps and next steps were discussed. Ectoparasiticide pet veterinary medicinal products include multi-use active substances under different chemical frameworks (plant protection products, biocides, veterinary medicinal products), and a need for a better collaboration between authorities and harmonisation between risk assessment methodologies under different frameworks were highlighted. A clinical view on ectoparasiticides used in companion animals was discussed.

The afternoon session of the CVMP meeting addressed alternatives to antimicrobial veterinary medicinal products and potential claims and demonstrating efficacy for alternatives to antimicrobials. The European Medicines Agency presented the definition of alternatives to antimicrobials, current and future regulatory framework applicable to alternatives to antimicrobials and presented the Reflection paper on promoting the authorisation of alternatives to antimicrobial veterinary medicinal products in the EU published by CVMP in July 2021. A discussion was initiated on the possible regulatory framework for the authorisation of alternatives to antimicrobials, focusing on potential medical claims for alternatives to antimicrobials and efficacy data requirements necessary to support such claims.

Coordination group for Mutual recognition and Decentralised procedures – veterinary (CMDv) held a meeting on 14.10.2021.

Updates according to Regulation 2019/6 of two documents were discussed:

  • CMDv/GUI/014 Guidance for the processing of generic and hybrid applications through MRP/DCP/SRP
  • CMDv/BPG/009 Best practice guide for the processing of SPC, labelling and product leaflet in support of MRP/DCP/SRP

Two new documents, prepared according to new CMDv tasks in line with the Regulation 2019/6, were discussed:

  • CMDv/BPG/XXX Best practice guide for the CMDv tasks related to pharmacovigilance
  • CMDv/BPG/XXX Best practice guide for handling of marketing authorisations for veterinary medicinal products under exceptional circumstances (NP, MRP, DCP)

Austria, Belgium, Ireland and Slovenia presented their plan on management of variations not requiring assessment in the union product database for veterinary medicinal products.

105th HMA MEETING

On September 5 the first part o the regular meeting of the Heads of Medicines Agencies (HMA) took place. The participants were addressed by the Minister of Health of the Republic of Slovenia, Mr. Janez Poklukar. He pointed out that one of the goals of the Slovenian presidency is to build the European Health Union. A well-functioning European regulatory system for medicines is an important part of it, and the network of heads of medicines agencies together with the EMA is its heart. To tackle the cross-border health crisis more effectively today and in the future, we need to improve the EU’s resilience and prepare for common solutions within the European Health Union.

In addition to regular content, participants discussed the role of AI in medicines development, digital medicines and safety of medicines, as well as progress in Real World Evidence.

On the second day of the meeting on 16 September 2021, the HMA endorsed a plan to relaunch the BEMA assessment, a program for assessing the regulatory system of the EU National Competent Authorities network. This will continue to ensure good practice in the field of medicines regulation. There was also a discussion on the future sustainability of the EU network, with the HMA being briefed on new opportunities for joint activities and participation in joint actions within the EU Health Program. The regulation on fees approved by the EC, which is currently under revision, will also play an important role. Progress was also presented in the field of preparations for the implementation of the Regulation on Clinical Trials at the EU level and the introduction of a new methodology “IM governance model”.

Joint meeting EU Directors for Pharmaceutical Policy & Pharmaceutical Committee

As part of Slovenian presidency of the EU Council, a joint meeting of Directors for Pharmaceutical Policy of EU Member States and the Pharmaceutical Committee of the European Commission took place on 8 and 9 July 2021. In this form, the meeting was organised for the first time and thus brought together policy makers in the field of medicinal products from the Ministries of Health and experts from national medicines agencies or public health institutions of the EU and EEA member states. The meeting was also attended by representatives of EMA and invited renowned international experts.  

The discussion focused on finding common EU solutions that can improve the accessibility and availability of medicines, while also addressing the issue of medicine shortages, especially where a lack of commercial interest may occur, such as in the case of antimicrobials, or in the case of repurposed generic and older medicines in oncology. This would contribute to the strengthening of the European Health Union and the implementation of the Pharmaceutical Strategy for Europe.

On the first day, topics related to innovation, accessibility and availability of antimicrobials in the EU were discussed. The importance of further comprehensive action in the field of antimicrobials was emphasised. It is important to build on and take advantage of the knowledge and cooperation developed so far. Antimicrobial resistance is a silent pandemic and the EU needs to invest all its efforts into addressing this situation to prevent a future crisis. Member states also discussed the possibility of a voluntary model based on joint tender, deriving from the experience with the supply of covid-19 vaccines, while not encouraging the overuse of antibiotics. The model should be piloted first.

The revision of the EU pharmaceutical legislation is an opportunity to examine various incentives, while addressing all other issues related to the availability, accessibility and use of antimicrobials. The European Commission has announced that discussions on future action at the EU level and on the revision of pharmaceutical legislation will continue during its forthcoming meetings.

On the second day, there was a discussion on possible solutions to support the repurposing of already approved, off-patent medicinal products, particularly in the field of oncology, where a significant unexploited potential exists. Repurposing is an opportunity for more effective and affordable medicines to treat cancer in areas of unmet needs. It has proven effective during the current pandemic. Due to the lack of financial interest from the pharmaceutical industry, the involvement of non-commercial stakeholders, such as academic institutions and not-for-profit organisations, was recognised as necessary to achieve this goal, which poses a number of challenges in approving the changed use of an already authorised medicine. It is therefore essential to create an appropriate environment that will support non-commercial stakeholders in their data acquisition activities for new therapeutic uses. 

The Pharmaceutical Strategy for Europe, the Europe’s Beating Cancer Plan, the announced European Health Emergency Response Authority (HERA) and the European Health Data Space offer an opportunity for joint action at the EU level in response to public health needs.

Scroll to Top