Ethical, Legal and Social Issues (ELSI) on Health Data Processing

• Are there any best practices or specific limitations? 
• Are there efforts for more coherent ELSI principles?
• Which enablers or which barriers do you experience?
• Current changes in legislation (e.g. in light of upcoming EHDS regulation)?

New Covid-19 variants

• How are MoH preparing for the next winter? Are there any specific plans or are you aware of any ongoing planning with regard to the new Covid-19 strains BA 2.86 (Pirola) and EG 5 (Eris)?
• To what extent are MoHs using lessons learned from the Covid-19 pandemic? Please give examples.

Biosimilar medicines

• Interchangeability: Does your country have a legal arrangement in place such that once a biosimilar is approved in the EU (or through some other mechanism) it is interchangeable, which means the biosimilar can be used instead of its reference product (or vice versa) or one biosimilar can be replaced with another biosimilar of the same reference product? If so, please briefly describe the arrangement?
• Substitution at point of issuing medicine: Can a pharmacist / dispenser substitute biological medicines with biosimilars at the point of dispensing (e.g., at a pharmacy/hospital)?
  • If so, is it a requirement of State-funded schemes / social health insurance reimbursement to substitute with the available medicine of lowest costs or medicines within a lower cost bracket? (i.e., only reimburse the preferred biosimilar)
  • If so, does the pharmacist/dispenser receive training or specific payment from the Government or insurer?                                                                                                                                                                                                                                       
• Has the above approach encountered criticism in your country?
• Influencing clinical prescribing of biosimilar medicines: How is this done (e.g., incentives as in Best Value Biologics Programme (BvB), described below)?
• Broad process of choosing preferred biosimilars: What is the overall process to determine preferred biosimilars for prescribing over their reference biological medicine? For instance, what broad criteria are used, and what organisation has responsibility for this?
• Response to the EMA September statement: Following the September statement from the European Medicines Agency (EMA) (presented below) on the interchangeability of biosimilars, is your country planning any changes to increase biosimilar penetration/uptake?

National Reviews/Inquiries of the COVID-19 Response

• Has a Review of the Response to Covid-19 been undertaken or is currently underway in your country? If so, please provide the title of the Review.
• What areas / topics are covered by the Review?
• How is the Review structured / undertaken?
• What type of Review was undertaken and what type of organisation undertook the Review?
• Are the Terms of Reference for the Review publicly available? If so, please provide a link to the Terms of Reference.
• Was the Review made publicly available? If so, please provide a link to the publication

National action plan on postviral / postinfectious syndromes

Does your country have a national action plan or similar strategic policy papers regarding postviral / postinfectious syndromes (in general or associated with specific pathogens, e.g. Long COVID)? We are interested in documents that cover aspects such as care pathways, healthcare planning and financing, data collection and registries, research, awareness raising and others. Please provide links to the relevant documents or websites?

Covid-19 impact on population´s mental health

• How does your country measure the pandemic´s effect on the population’s mental health?
• Which tools or monitoring (systems) does your country use to obtain information on the mental health of the population?
• Which subgroups are most affected in your country?
• What implementation measures have been/are being taken to respond to the impact of the pandemic?
• How does your country deal with suicidality in the wake of the pandemic? Is there any special support since the pandemic?

Covid-19 management tool

Did your country used, during the COVID-19 pandemic, a specific tool to determine the level of severity of the pandemic, at national level (e.g., level 1, level 2, level3)?  

If yes,

• was this tool linked to public health measures (e.g. different testing, isolation, quarantine, mask wearing, …, measures depending on the level) ?
• what were the different indicators included in that tool?
• is this tool still applicable today? Why?

Health crisis procedures and exercises

• We are interested to learn more about your organisation´s different roles in case of a health crisis emergency (for example an infectious disease outbreak).  If your organisation is involved in management of a public health crisis, what are your duties?
• Did your organisation ever simulate these emergencies for an (internal or joint) exercise? If yes, what are your experiences with this health crisis simulation and are you willing to share some documents?  A wide range of crisis exercise scenarios is welcome: accidents with chemical or biological agents, infectious disease outbreaks,..

Treatment of long Covid patients

In order to keep up with this topic, we would kindly ask for a follow-up to REF 14 (07/06/21):

• How does your country organise the physical and psychological treatment of long COVID patients, especially with regard to Mental Health?
• Are there specialized clinics/departments/centres in place or are specialized clinics/departments/centres currently being developed?

       If so, please provide details, such as:

       - Which professional groups (specialists, nurses, psychologists, …) and disciplines are involved?

       - How can individuals access the clinics (walk-in, referral …)?

       - Are the clinics stand-alone entities or part of larger institutions such as hospitals or primary care centres?

• Are there specific pathways in the treatment of children and youths established?

       If so, please provide details, such as:

      - Is there a publicly funded facility for parents to obtain publicly funded long Covid consultations with specialised physicians?

      - Have any day care centres been set up for children affected by long Covid?

• Is there any available data on waiting times or information on bridging measures during the waiting period for a specialized programme?
• Is there any legal protection or special support for employees (not to get terminated or pressured, e.g. helpline) in the process of diagnosis-finding?

Vision on resilience indicators

• As COVID-19 measures has been lifted or relaxed around Europe, which COVID-19 indicators, if any, are foreseen to be measured long-term in your country, and are there any thresholds defined that would trigger reintroduction of measures or emergency action?
• Have analyses been performed in your country regarding population adherence to NPIs (e.g. via mobility data, surveys), and/or has there been a weighted analysis of effectiveness and economic viability of measures on another basis?
• Have strategies/tools/mechanisms for measuring or evaluating the improvement of health system resilience been set up or are there plans to do so?