FAQ : Directive on cross-border healthcare

• All European Union and European Economic Area citizens and their families.
• Nationals of other countries residing legally in the 27 EU member States, but not those residing in European Economic Area countries (Iceland, Liechtenstein, and Norway).

• all healthcare provided or prescribed in a European member State
• the prescription and dispensation of medications
• the prescription of medical devices provided as part of a healthcare service.

However, the following are not covered:

• long-term care (home care services)
• organ donations
• public vaccination campaigns.

• The 27 European Union Member States and the European Economic Area countries (Iceland, Liechtenstein, and Norway).

It provides patients with information on:

• healthcare quality and safety-related standards and guidelines, including provisions for the oversight of healthcare providers.
• the healthcare providers who are subject to these provisions
• healthcare providers' authorization to provide care and any restrictions on their professional practice
• healthcare facility accessibility for people with disabilities
• patients' rights with regard to cross-border healthcare, procedures and conditions for exercising these rights, and how healthcare costs are reimbursed.
• the legal and administrative processes for appeal and redress following the provision of cross-border healthcare
• the information that must appear on prescriptions for medication or medical devices that are written in another member State
• the contact information for the member States' national contact points

All public or private healthcare providers, whether or not they are "conventionné" (adhere to a national agreement between practitioners and the social security system), practicing legally in a European Union or European Economic Area (Iceland, Liechtenstein, and Norway) country.

1) If you are covered by the French healthcare system:

• your regular doctor can also tell you about available care
• you can get this information from the national contact point of the country in which you plan to seek care (see online list)
• you will need to check whether the healthcare provider you have chosen, especially if you have chosen a specialist physician, can be accessed directly or upon referral from a GP.

2) If you are covered by another country's healthcare system:

• you can get this information from your home country's national contact point or from your local health insurance fund (see online list)
• your regular doctor can also tell you about available care.
• The website Annuaire santé is a service provided by the French Health Insurance system. You can use this site to do a multi-criteria search (name, specialty, location, type of care) for a healthcare professional (doctor, nurse, pharmacist, etc.) or a healthcare facility (hospital, clinic) authorized to provide care in France. It also lists fees and reimbursement rates for care and services.
• You are not required to follow France’s coordinated care pathway (selecting a primary care physician and seeing them before consulting a specialist). You will need to show the GP or specialist your S2 form as proof that the coordinated care pathway does not apply to you and to ensure that you are not charged an extra fee.

The healthcare provider you see is required to provide you with clear information on his/her rates.

The national contact point of the country you plan to visit may also be able to provide you with information on applicable healthcare rates.

Before you decide to receive healthcare abroad:

• you will need to find out about your entitlement to coverage of cross-border health care
• you will need to be aware of the financial implications and the requirements for coverage of your expenses.
• you will need to check how much of your health care expenses will be out-of-pocket (all of your expenses or the flat-rate charge known as the « ticket modérateur », travel expenses, and the costs of translating your medical files).
• you will need to know whether a prior authorization for care is required
• you will need to learn from your doctor about the treatment you wish to receive and identify the health care professional or facility you will be contacting.
• you will need to assess your need for private travel insurance or supplementary health insurance (coverage for expenses in private facilities, medical transport or repatriation, etc.)

Before you travel abroad for treatment:

• you will need to learn about your rights to informed consent
• you will need to have your medical file transferred to your chosen health care provider in France and have it translated if necessary
• you will need to consider the possible need for an interpreter when you meet with your health care provider
• you will need to set up follow-up treatment in your home country to ensure continuity of care.

During your treatment abroad:

• you will need to have your health care provider add your diagnosis, test results, treatment results, list of pharmaceuticals administered, post-op results, etc. to your medical file, either in writing or electronically.
• you will need to gather and secure all of the documents you will need to submit to the health fund to which you belong to apply for reimbursement.

Following treatment abroad:

• you are entitled to pay the same fees for health care as those insured in the country in which you receive care.
• you will need to make sure to get prescriptions that are in line with the applicable regulations so that they can be used in your State of residence when you go home.
• you will need to have your medical records transferred once they have been added to by your healthcare provider in France.

Before you leave France, it is important that you contact the other country's national contact points and before you come to France, France’s national contact point (soinstransfrontaliers@cleiss.fr) to get all the information you need to ensure that your cross-border care goes forward smoothly.

Directive 2011/24/EU guarantees each patient the right to obtain a copy of his/her medical file, containing iinformation such as diagnosis, test results, assessments of treatment by the patient’s various health care providers, and information on any treatment or surgery provided.

Your country’s designated national contact point can provide all the information you need on how to get a copy of your medical file.

If you receive care in France, make sure that the health care provider you see adds to your medical file (diagnosis, test results, treatment results, list of pharmaceuticals administered, post-op results, etc.)

You can request access to your medical file, either personally or through your physician, by sending a registered letter to a health care professional or facility.

You are entitled to access your file within a maximum of 8 days following your request, and at the earliest following a 48 hour waiting period. The maximum turnaround time is 2 months for medical information that is more than 5 years old.

You can access your file free of charge if you go in person. If you want photocopies of your information, you cannot be charged more than the cost of photocopying or any postal fees.

a) Denial by a private-practice professional:

• Appeal to the medical or dental association (Conseil départemental de l’ordre professionnel) that covers the doctor’s or dentist’s place of residence
  Or
• Apply for interim relief before the social security affairs section (pôle social) of the district court (Tribunal Judiciaire) with jurisdiction over the practitioner’s office location.

b) Denial by a public or private health care facility:

• within a 2-month deadline following a denial or failure to reply, you can apply to the Committee for access to administrative documents (Cada, Commission d’accès aux documents administratifs), attaching a copy of your request to access your file, the facility’s denial, and the information needed to identify your file, to your submission. By phone: +33 (0)1 42 75 79 99 – By mail: TSA 50730 75334 Paris Cedex 07 – By email: cada@cada.fr

Cada then has a one-month deadline to notify you of its opinion. If the facility fails to comply with this opinion (continued denial of access), the patient can bring action before the administrative court (tribunal administratif) for ultra vires.

• test results,
• appointment, operation, exploration, or hospitalization reports,
• treatment protocols and prescriptions used,
• follow-up sheets and correspondence between health care professionals.

If you receive care in another country, make sure that the health care provider you see adds to your medical file (diagnosis, test results, treatment results, list of pharmaceuticals administered, post-op results, etc.)

An indicator is a tool for measuring a healthcare performance (e.g. the rate of nosocomial infections in a healthcare facility, the rate of traceability of pain assessment found in the patient record) or the management of structures (e.g. waiting times in emergency rooms) which makes it possible to make a valid and reliable estimate of the quality of care and its variations over time and space.

The quality and safety indicators are designed to assess the quality and safety of care in all public or private French hospitals and clinics. They are implemented with the help of healthcare professionals, patients and users of the healthcare system.

The results of quality of care indicators are used to :

• inform users and improve the quality of service provided to patients,
• encourage health professionals to improve practices and implement corrective actions,
• steer the policies of public authorities.

1) if you are considering coming to France to seek care:

• you can check the website of the French National Health Authority (HAS), which provides quality indicators for each healthcare facility.

2) if you are planning to seek care in another European Union member State:

• you can get this information from your home country's national contact point or from your local health insurance fund.

Since cross-border healthcare is provided pursuant to local law in the country of treatment, patients’ rights under that country’s domestic law apply. You have the same rights and privileges in terms of access to health care and treatment as domestic patients: rights to choose your health care provider, to informed consent, to equal treatment, to privacy, to access your medical records, to appeal and receive compensation, and to information on the cost of care.

For France, please refer to the page: Patients’ rights in France.

For other countries: the national contact point of the foreign country in which you receive treatment (list) or the health care provider you have chosen can supply more information on these rights.

Pursuant to Directive 2011/24/EU, each member State must determine the rules for writing a cross-border prescription in order to ensure that medications and medical devices are dispensed securely and that the prescription is clearly understood by the health professional in the other country. Furthermore, the enforcement directive 2012/52/EU establishes a minimum set of information that must appear on all cross-border prescriptions.

Your prescription must contain at least the following information:

• Identification of the patient: Last name(s), First name(s), Date of birth
• Authentication of the prescription: Date issued
• Identification of the healthcare professional issuing the prescription: Last name(s), First name(s), Professional qualifications, Direct contact information (email address and telephone or fax number preceded by international country code)
• Professional address (including the name of the Member state), Signature (either handwritten or digital, depending on the chosen prescription format)
• Identification of the prescribed pharmaceutical, where applicable: common name, brand name indication, pharmaceutical form (tablet, solution, etc.), quantity, dosage, and directions for use.

if the prescription is written outside of France, you can check with the other country's national contact point for information on the provisions applicable in that member.

the health professional writing the prescription must be licensed to prescribe in his/her home member State.

A prescription written in France must include the following information:

• The patient's identity: Last name, first name, sex and birthdate, weight and height if necessary.
• The prescribing doctor's identity: Last name, first name, capacity, title or specialty where necessary, professional address specifying "France," phone number preceded by country code "33" and email address, prescriber's (hand-written or digital) signature, and date of the prescription.
• Medications: Common denomination of the product, i.e. molecule name. The medication must also be identified by its pharmaceutical form, quantity, dosage and usage instructions. If the prescription is for a biological medicinal product, it must also include the brand name of the prescribed drug in addition to the common denomination. If the doctor does not want the medication to be substituted with a generic, the brand may be written on the prescription along with the annotation "no substitutions" and the reason for this request.

The health professional writing the prescription must be licensed to prescribe in France.

Make sure to request a prescription in line with these requirements.

• the medications or medical devices prescribed do not have market authorization in the State where treatment is being received
• the prescribed medications or medical devices do not have market authorization in the other member State
• the professionals licensed to dispense medical devices or medications consider that filling the prescription is not in your best interests as a patient, or if they have legitimate, justified doubts as to the authenticity or the content of the prescription, or as regards the capacity of the healthcare professional who wrote the prescription.

To appeal an administrative decision, you will need to start by filing a submission with your local health insurance fund (CPAM)’s arbitration board (Commission de recours amiable, CRA). (list of France’s local health insurance funds).

If your appeal is denied, you can then bring proceedings before the social security affairs section (pôle social) of the district court (Tribunal Judiciaire).

As a last resort, you can appeal to the court of appeals (Cour d’appel) and/or to the court of cassation (Cour de Cassation).

To appeal a medical decision, you will need to start by asking your local health insurance fund (Caisse d’Assurance Maladie) to conduct an expert medical assessment.

Moreover, on France’s Ministry of Justice website, you can search for contact information for each of the courts to which you can appeal by entering the name of the town in which the health insurance fund that denied the S2 form is located.

Important: A member State of insurance may require prior authorization for the coverage of certain types of care requiring a hospital stay of at least one night or the use of major medical equipment.

In addition, they may require those insured under other States' healthcare systems to go through the same administrative and regulatory formalities for reimbursement (healthcare pathway, consulting a primary care physician first, getting a medical prescription, etc.)

1) If you are insured in a State other than France:

You will need to get this information from one of the national contact points of the country in which you are insured or from your local health insurance.

2) If you are covered by the French healthcare system:

You will need to apply for prior authorization (S2 form) from your local health insurance fund (CPAM, MSA, etc..) for any of the following types of care:

• Care requiring a hospital stay of at least one night;
• Care requiring the use of major medical equipment: scintillation camera with or without a positron coincidence detection system, positron emission tomography, positron camera, clinical nuclear magnetic resonance imaging or spectroscopy, CT scanner, hyperbaric chamber, medical cyclotron;
• Cardiological procedures using medical imaging, via the endovascular route;
• Neuroradiology procedures via the endovascular route;
• Procedures on the crystalline lens, with or without a vitrectomy; or any other surgical ophthalmological procedure;
• Ambulatory carpal tunnel and other superficial nerve release procedures, as well as other surgical hand procedures;
• Treatment of chronic renal insufficiency through extrarenal purification;
• Cancer treatment;
• The examination of a person's genetic characteristics or identification of a person through genetic fingerprints for medical purposes;
• Clinical and biological assisted reproductive technology procedures and biological prenatal diagnostics activities.

However, for all other types of care that do not require prior authorization (S2 form) you will need to follow France's prior authorization procedure for the following care/services:

• Dentofacial orthopedic treatments,
• Massage-physical therapy procedures requiring prior authorization beyond a predetermined number of sessions,
• Certain laboratory tests and analyses,
• Certain cholesterol-lowering drugs, certain medical prostheses,
• Certain medical prostheses,
• Long-distance transportation (over 150 km), frequent transportation, commercial airline or boat transportation, transportation connected to the care or treatment of children and adolescents enrolled in early-intervention medical-social centers (centres d'action médico-sociale précoce/CAMSP) and medical-psycho-pedagogical centers (centres médico-psycho-pédagogiques/ CMPP).

• if the care you intend to receive is not reimbursed by the health care system of the country in which you are insured and is not part of that country's prioritized list of health services
• if the care is not appropriate to my state of health
• if the care can be provided in my country of residence within a reasonable timeframe.

1) If you are insured in a country other than France:

You can get this information from your local health insurance fund in your home country.

2) If you are insured in France:

If you are covered under the general scheme, you will need to apply for this document (S2 form) by post to:

CPAM DU MORBIHAN
CNSE – MÉDECIN CONSEIL
CS 80330
56018 VANNES CEDEX

For other French social security schemes, you will need to apply for this document (S2 form) from your local health insurance fund in France.

You must indicate:

• the type of care you intend to receive as documented by a detailed medical certificate
• the medical reasons for which you intend to seek care elsewhere in Europe
• the facility in which you will receive care
• the expected beginning and end dates of your course of treatment.

You must apply for your authorization far enough in advance so that the health insurance fund can process it before you leave.

You will receive notice of prior authorization or refusal of coverage within 14 days of receipt of your application. If you receive no response within this timeframe, your application has been approved.

To appeal a denial, you may contest the decision before your health insurance fund's arbitration board (commission de recours amiable).

Before you leave, you need to inquire whether the care or treatments you plan to receive will require prior authorization from the Health Insurance Fund in order to be covered. If so, prior authorization will be also required for coverage of scheduled care in another State.

Your designated primary care provider must fill out the request for prior authorisation of coverage and give it to you. You must then complete it and send it to the medical Service of your local Health Insurance Fund in France. You must also send the prescription (original or copy) for care or procedures performed by allied health professionals (physical therapists, speech therapists, orthoptists), for travel expenses for medical purposes, for lab exams or for medical equipment along with your application.

You will receive notice of prior authorization or refusal of coverage from your Health Insurance Fund within a period of 15 to 21 days of receipt of your application, depending on the nature of the care. If you receive no response within this timeframe, your application has been approved.

If your request for prior authorization has been denied, the decision must be reasoned and include instructions on the appeals procedure.

Under the Directive No. 2011/24/EU, the patient is generally required to pay for healthcare upfront and then apply directly to his/her local health insurance fund in the home member State for reimbursement.

1) If you are covered by a foreign social security system:

Your home State's national contact points or your local health insurance fund in your home state can inform you about the applicable reimbursement process.

2) If you are covered by the French social security system:

There are various possible situations:

a) If you have received prior authorization (S2 form) for care subject to prior agreement:

• You must show this authorization to the facility where you plan to receive care.
• If a direct settlement system (tiers payant) is available, the local social security fund will cover your expenses and you will only have to pay any applicable copayment (ticket modérateur) or out-of-pocket flat fee (franchise).
• If you have paid upfront, you will need to submit your paid bill along with your prior authorization to the local health insurance fund in the country where you received care. That fund will reimburse your expenses pursuant to local legislation.
  Important: if you go to a private health care provider or facility that has not signed an agreement with the local social security system, your S2 form will not be recognized. You will need to pay upfront and then submit your paid bills directly to your local health insurance fund in France.
• if you do not apply for reimbursement in the country where you receive care, or if you receive care from a professional or facility in the private sector, you will need to pay all of your expenses upfront and apply to your local health insurance fund in France when you return home.
  Important: if you apply for reimbursement when you return home, you will have to choose between the reimbursement rates applicable in the country in which you received care or those applicable in France. Depending on how much you spent, it is very important to check the rates applicable in each country and to contact the local health insurance funds or national contact points before you make this decision.

b) If you receive ambulatory care not subject to prior authorization:

You will need to pay your expenses upfront and then apply to your local health insurance fund for reimbursement when you return home. Your local sickness fund will reimburse you only according to French rates.

You can bring proceedings before either:

• the Defender of Rights (Défenseur des droits), by submitting your complaint directly via the online form;
• the director of the local health insurance fund (Caisse Primaire d’Assurance Maladie/ CPAM - list of CPAMs) and/or the health insurance mediator (conciliateur de l’assurance maladie), by letter;
• the head of the local chapter of the appropriate professional association : medical association, nurses’ association, dental surgeons’ association (see online list).

You will need to fill out and submit form S3125C to your local health insurance fund along with your paid medical bills and proof of payment to apply for reimbursement of your health care expenses in another country.

You have a two-year deadline in which to apply to your local health insurance fund for reimbursement of your care.

If the amount of your reimbursement is not what you expected, you will need to start by filing a submission with your local health insurance fund (CPAM)’s arbitration board (Commission de recours amiable/ CRA) (list of France's local insurance funds)

If your appeal is denied, you can then bring proceedings before the the social security affairs section (pôle social) of the district court (Tribunal Judiciaire).

As a last resort, you can appeal to the court of appeals (cour d’appel) and/or to the court of cassation (Cour de Cassation).

Moreover, on France’s Ministry of Justice website, you can search for contact information for each of the courts to which you can appeal by entering the name of the town in which the health insurance fund to which you belong is located.

Important: the applicable law is that of the country in which the care was provided:

1) If the care was provided in France:

Three procedures can be conducted at the same time  :

• Arbitration proceedings: you may request arbitration with the facility, either by applying directly to the hospital's director, or by going through the medical or non-medical ombudsman, or the user relations and quality of care board (Commission des relations avec les usagers et de la qualité de la prise en charge (CRUQPC), by letter specifying your complaints regarding your care. You may be offered a direct transaction with the healthcare facility's insurance company. Under certain conditions, you may also apply to the medical accident arbitration and compensation board (commission de conciliation et d'indemnisation des accidents médicaux (CCI - http://www.oniam.fr/trouver-ma-commission et http://www.oniam.fr/indemnisation-accidents-medicaux/partenaires). If the seriousness criteria are met, this board conducts an examination at no cost to the applicant, considering evidence from both parties, to determine the cause-and-effect relationship between the care provided and the harm reported by the patient.
• Litigation proceedings: proceedings for damages may be brought against the practitioner, either before a civil court if the case involves a physician or other healthcare professional with his/her own practice or a private healthcare facility, or before an administrative court if the case involves a public health facility where the doctor practices, with the patient being considered a public service user. On France’s Ministry of Justice website, you can search for contact information for each of the administrative (public health care providers) or civil courts (private health care providers) to which you can apply by entering the name of the town in which the health care provider in question is located.
• Disciplinary proceedings: You may submit your complaint to the professional association to which the health professional (practicing either in a public facility or in a private practice) belongs in order to bring ethics-related disciplinary proceedings. (see online list of associations)

2) If the care was provided in another member State:

• You will need to get this information from the national contact point of the country in which you received care.

• Always make sure you have a European health insurance card (EHIC) before you go abroad.
• This card covers unscheduled (medically necessary) care you may receive during a trip abroad. If you don't have this card and contact the local health insurance fund in the country you are visiting, the foreign health insurance fund may request this document from your local health insurance fund in your home country.
• If you do not apply for reimbursement of your healthcare expenses in the country you are visiting, you will need to pay upfront and then apply to your local health insurance fund in your home country for reimbursement.

Important: if you apply for reimbursement when you return home, you will have to choose between the reimbursement rates applicable in the country in which you received care or those applicable in your home State. Depending on how much you spent, it is very important to check the rates applicable in each country and to contact the local health insurance funds or national contact points before you make this decision.

• the EHIC also covers care for chronic or preexisting conditions as well as pregnancy and delivery if the purpose of your trip abroad was not to receive care.

The ERNs are being set up under the 2011 Directive on patients' rights in cross-border healthcare and their work stated on 1st march 2017. This Directive also makes it easier for patients to access information on healthcare and thus to increase their treatment options.

Cooperation at EU level makes a real difference to rare diseases patients and their families, as well as the health professionals helping them. No country alone has the knowledge and capacity to treat all types of rare, complex and low-prevalence conditions and diseases, but by cooperating and exchanging life-saving knowledge at European level through ERNs, patients across the EU will have access to the best expertise available.

European Reference Networks (ERNs) are networks involving healthcare providers across Europe. They aim to tackle complex or rare diseases and conditions that require highly specialised treatment and a concentration of knowledge and resources. Currently, 24 thematic ERNs are active, involving over 900 medical teams in more than 300 hospitals from 25 EU countries, plus Norway.

The Commission has created the framework for the ERNs and provides grants and technical networking facilities to support network coordinators. However, the driving forces behind the ERNs are healthcare providers and national health authorities.

The 24 ERNs will work on a wide range of rare diseases. The full list of rare and complex pathologies can be found here: https://ec.europa.eu/health/ern/networks_en

Between 6 000 and 8 000 rare diseases affect an estimated 30 million people in the EU. An unfortunate feature of rare diseases and complex conditions is the scarcity and fragmentation of specialist knowledge, which is often not available in the patient's region or country. Many patients therefore do not find a satisfactory explanation for their symptoms or the necessary knowledge on treatment options. By consolidating knowledge and expertise scattered across countries, the ERNs will give healthcare providers access to a much larger pool of expertise. This will result in better chances for patients to receive an accurate diagnosis and advice on the best treatment for their specific condition.

ERNs are not directly accessible to individual patients. However, with the patients' consent, and in accordance with the rules of their national health system, a patient's case can be referred to the relevant ERN member in their country by their healthcare provider.

To review a patient's diagnosis and treatment, healthcare providers/members of an ERN will consult, exchange information and share knowledge with other members of the network. Coordinators of a specific ERN can convene inter-ERN 'virtual' advisory boards composed of medical specialists across different disciplines. A dedicated IT platform and telemedicine tools can be used for this purpose.

You can access european reference networks (ERNs) through your primary care physician if you are outside the rare disease network of expertise, or through the physician who is currently providing care in this expert circuit. This doctor will refer you to a specialised facility that can seek advice and expertise from the relevant ERN. The ERN will try to provide the best possible information and recommendations to the health care facility so that your doctor can assist you under the best conditions.

The 24 ERNs currently cover the main clusters of rare, complex and low-prevalence pathologies. In the future, the ERN could possibly be extended to other diseases.

Aside from the diagnosis and treatment of patients, the ERNs will also facilitate research cooperation, joint trainings, knowledge generation, the development of medical guidelines, the facilitation of large clinical studies to improve understanding of diseases, the development of new drugs and medical devices by gathering a large pool of patient data and the development of new care models, eHealth solutions and tools.

ePrescriptions and digital Patient Summaries can be exchanged between EU countries thanks to the new eHealth Digital Service Infrastructure put in place by the European Commission: the MyHealth@EU network, secure environment through which the health data can be exchanged with respect for the General Data Protection Regulation (GDPR).

France has integrated the MyHealth@EU network to ensure the treatment of European citizens within the European Union via Sesali, the new service offered by the Agence du Numérique en Santé (ANS, French eHealth Agency) to health professionals. This service is accessible at www.sesali.fr and enables French health professionals holding a CPS or eCPS card to access in a secure, standardised manner, and in French, the medical summary of a patient from another EU country.

The ePrescription and eDispensation allow EU citizens to obtain their medication in a pharmacy located in another EU country, thanks to the online transfer of their electronic prescription from their country of residence where they are affiliated, to their country of travel. In return, the country of residence is informed of the medicines obtained in the country of travel.

It provides information on important health related matters, such as allergies, current medication, previous illness, surgeries, etc. The digital Patient Summary is meant to provide doctors with essential information in their own language concerning the patient, when the patient comes from another EU country and there may be a linguistic barrier. In the long term, the medical record will be enhanced with lab results, medical images and hospital discharge reports.

Health technology assessment (HTA) summarises information on the medical, economic, social and ethical issues related to the use of a health technology such as drugs, medical equipment or in vitro diagnostics. HTA answers clinical questions such as the effectiveness of the new technology compared to existing alternative health technologies. It can also answer economic questions such as the assessment of costs involved for the health care system. HTA is therefore an essential tool for Member States to ensure the quality, accessibility and sustainability of healthcare.

A new EU Regulation 2021/2282 entered into force in January 2022. It establishes a sustainable legal framework for enhanced HTA cooperation within the EU. Member States' HTA bodies will cooperate to produce joint work in the field of HTA. This includes joint clinical assessments of new centrally authorised medicines and certain high risk medical devices. In addition, joint scientific consultations will provide scientific advice to health technology developers on clinical study design and clarify evidence for HTA. Finally, long-term foresight exercises will identify the most promising health technologies at an early stage, to help health systems get ready for them.

The new regulation helps Member States to pool their resources and expertise on HTA. Joint clinical assessments will provide Member States with timely and high quality scientific reports, which will help them to make timely and more evidence-based decisions on patient access to new medicines and medical devices.

It also provides more clarity and predictability on clinical data requirements for technology developers and simplifies the submission of essential clinical data to a single point of contact at EU level.

Patients, clinicians and relevant experts will be able to participate in the HTA and provide input into the preparation of joint clinical assessments.

Member States will give due consideration to the EU Joint Clinical Assessment report when carrying out a national HTA on a relevant health technology. They may supplement the joint clinical assessment with additional clinical analyses that may be required in the national HTA process (analyses related to the national epidemiology of diseases or the specific national healthcare context). They may also complement the joint clinical evaluation with non-clinical analyses (e.g. on budgetary impact or cost-effectiveness). Finally, Member States remain responsible for drawing conclusions on the overall value of a new health technology for their health care system, as well as for pricing and reimbursement decisions.