Regulatory competences

Question 1

Pharmaceuticals are

Answer 1

Usually intended as medical products, chemicals, as any substance or combinations of substances presented as having properties for treating or preventing diseases in human beings

Question 2

Medical devices are

Answer 2

any instrument, apparatus, appliances, software, implant, material or other object intended by the manufacturer to be used for human beings for one or more medical purposes.

Question 3

Pharmaceuticals and medical devices are goods and that means

Answer 3

Within the meaning of the EU single market
legislation such as the free movement of goods among states of the union and the regulatory framework of competition law.

Thus they are clearly goods, but with specific features that distinguish them from other goods, and consequently impose a sector-specific regulatory framework following the whole cycle, especially on pharmaceuticals (very high protection over intellectual property rights)

Question 4

why are IP rights so relevant to medicinal products?

Answer 4

Actually they are not necessary per se in order to sell medicinal products, however they are a means through which pharmaceutical companies are able to protect the result of their costly and timeconsuming activities of research and development of new and improved products, as well as to recoup the costs and the risks incurred in during that process.
Patents are the primary IP rights associated with medicinal products.

Question 5

A European patent is

Answer 5

a bundle of national patents that once granted needs to be validated and
maintained in each of the states in which the patent has been sought and validated in the first place. A European patent can be
applied for before the EPO, that will analyze the request and evaluate its merits and eventually grant the patent to the company,
which will last 20 years from the date of filing.

Question 6

The requirements for a patent under the EPC are:

Answer 6

• the invention must be new
• The invention must involve an inventive step
• It must be susceptible to industrial application, something useful in the industry.
• It must be relevant for medicinal products
• In case of an already known chemical substance, the patent is still available is the substance will be meant for the treatment of
  human body or surgery/ therapy
• If the substance is already known for medical use, the patent is still available if it will be meant for a different purpose not
  included in the state of the art of the previous use.

Question 7

In order to obtain a market authorization there are some common features, and the product would need to

Answer 7

meet the standards of quality, safety and
efficacy, and it shall show a favorable benefit-to-risk ratio.

Question 8

There are several procedures through which a medicinal product in the EU context can get a market authorization and thus reach
market access such as:

Answer 8

• a centralized procedure conducted by EMA
• a mutual recognition procedure ( used when a product s already authorized in at least one member state),
• a decentralized procedure and
• a national procedure.

Question 9

The issue of the pricing and reimbursement of the medicinal products is

Answer 9

not harmonized at EU level and thus stays in the competences of the Member States, as stated inarticle 168 TFEU.

Question 10

The main current issues on free movement of health professionals are:

Answer 10

• education and professional training, which remains among the competences of Member states. Why are we so resistant to change a test to enter medical school even if it is widely shared that the test is not good? Power ! if I change the rules, I won’t have the power anymore, I am on the power side and therefore I resist changing the rule.
• Specialization. More than 8000 regulated professions in 400 hundreds more or less categories. There is a high specialization
  and high request of healthcare professionals, which are of course regulated also given the relevance of their tasks. The more
  you are specialized the more that specialization is specific of Member States and this creates and additional problem when it
  comes to the free movement of health professionals, as they will be highly affiliated with the state in which they specialized
  and not ready to move elsewhere.

-The aging of population is another relevant issue, since getting old brings you to be more ill and the demand of health professionals connected to aging of population increased.

-digital literacy, since it is hard to teach technology to doctors who are 60, easier with young health professionals. There is a
natural resistance even though the European health system is implementing more and more technology in its system.

• patient-centered approach; this entails a different approach to the system that connects as well with the aging population
  mentioned before

Question 11

In order to overcome the different in the educational and professional training sectors and ensure the free movement of
professionals of under Articles 45, 49 and 56 TFEU the union has developed four main mechanisms:

Answer 11

• General Systems; under this system the profession will be regulated in the home and in the host country, with the applicant
  having full access to the same profession in both. Otherwise if it is not regulated in the home country, it evens out if the
  applicant has worked full-time in that profession for one year in the past 10, gaining this way the recognition of a diploma for
  that profession. In both of these cases compensatory measures can be imposed on the applicant when there are substantial
  differences of education, therefore some sort of adaptation period or shadowing period is required in order to fill theeducational gap.
• Automatic Recognition; under this system professionals with a diploma complying with minimum training requirements, such
  as minimum hours spent studying and minimum practice time, under Directive 2005/36 on the recognition of professionals
  qualifications can benefit from automatic recognition. This system applies to seven sectoral professions, such as doctors,
  nurses, midwives, dentists, pharmacists, architects, veterinary surgeons
• Recognition based on professional experience; under this system, if the applicant falls within the professions listed in the Directive 2005/36 and the host country requires specific knowledge and abilities, then automatic recognition is foreseen if the required minimum duration and nature of the professional experience laid down in the Directive are concretely met.
• • Recognition based on professional experience; under this system, if the applicant falls within the professions listed in the
    Directive 2005/36 and the host country requires specific knowledge and abilities, then automatic recognition is foreseen if the
    required minimum duration and nature of the professional experience laid down in the Directive are concretely met.

Question 12

the European Professional card is

Answer 12

not a real card, but rather an electronic certificate issued via the first EU-wide fully online procedure for the recognition of qualifications ( part of the Internal Market Information System). It does not replace the traditional recognition procedures under the
Professional Qualifications Directive, but anyway it facilitates applications for temporary or permanent professional activity in another EU country.

Question 13

given the shortage of health workers because of the sanitary crisis, the Commission

Answer 13

simplified procedures to facilitate mutual recognition of qualifications in accordance with Directive 2005/36, it made derogations from the general regimes in place and eased the process of recognition of health professionals with diplomas from outside the EU

Question 14

For the purpose of temporary and occasional service provision, where these health professionals move temporarily to another
Member State to strengthen the workforce for a limited period

Answer 14

only a simple prior declaration may be required of them, without any need to wait for a decision from the host Member State authorities. Such declaration obligations can be waived unilaterally by the host Member State, either in general or for particular periods, activities or sectors.

Question 15

EU citizens can rely on EU rules concerning the coordination of social security to

Answer 15

receive the planned
treatment abroad subject to prior authorization, and additionally to the provisions of Directive 2011/24/EU, which regulates the application of patients’ rights in cross-border healthcare.

Question 16

In order to receive planned treatment abroad there is in fact the need for a

Answer 16

prior authorization, intended as the request to be treated/ receive a procedure in another MS ( or in UK and Switzerland), and if the authorization is granted than the cost of the
procedure will be the same as it is for locals, there will be no added fees. The agreement must include the host institution of
course, and in case of health insurance perhaps as well the health insurance of the individual receiving the procedure.

Question 17

There are several legal and organizational barriers hindering the deployment of eHealth technologies in Europe,

Answer 17

such as the fragmentation of rules on the protection of personal Data across the EU and the lack of a cohesive interoperability across MS.

the Commission has proposed a measure
to facilitate secure online access to medical health data and to achieve a widespread deployment of telemedicine services by
2022. (not yet happened)

Question 18

There are also various systems of healthcare and health insurance that coexist within the Community, including roughy three categories:

Answer 18

• Wholly public systems; in public systems the financing is indeed public, and the care is provided free of charge. It is the case
  of the UK national health system.
• Hybrid systems; there may be financing coming from both public or private sources or a combination of these, whilst the care
  is provided instead in a reimbursement basis. This is the case of the Netherlands for example.
• Private insurance systems; this last model is paid for directly by the patient who subsequently is reimbursed by his health insurer, and depending on the type of organization these systems will be either tightly managed and relatively closed, or more flexible intheir management and relatively open.

Question 19

We have said previously that an
individual in order to be treated in another member state must seek authorization from the competent institution in order to be
allowed to do so. This is so stated in Regulation 883/04 that covers the

Answer 19

coordination of social security systems, which
additionally provides that the authorization must regard a treatment/ procedure included in the law of the home state, but that
cannot be completed in the required time given the state of health of the individual, or maybe for a lack of facilities of the home
state.

Question 20

Provisions of directive 2011/24

Answer 20

• Article 3; health systems in the Union as hubs of social protection and social cohesion.
• Article 4; Member states retain the responsibility for providing safe, high quality, efficient and quantitatively adequate
  healthcare to citizens on their territory.
• Article 7; Member states of affiliation shall ensure the costs incurred by an insured person who receives cross-border
  healthcare are reimbursed. Gives MS states the discretionarily to understand the level of healthcare an insured person isentitled to receive, and to assess the level of assumption of the costs.
• a further paragraph of
  article 7, the cost of cross-border healthcare shall be reimbursed or paid directly by the MS of affiliation accordingly with
  the costs it will have incurred had the healthcare been provided in its territory( therefore it will be paid by the home state).
• Article 8; establishes that the grant of a prior authorization shall be restricted to what is necessary and proportionate to the objectives to be achieved, but it shall not be used as a tool to carry out arbitrary discrimination or as an unjustified obstacle
  to the free movement of patients. The prior authorization will be in principle limited to healthcare subject to planning requirements, involving overnight hospital accommodation and requiring the use of highly specialized and cost-intensive medical infrastructure/equipment or when it involves treatment presenting a particular risk for the patient or the population.

Additionally the home state may not refuse to grant prior authorization when the patient is entitled to the healthcare in question, and the latter is not available to him or her in the home state.

Question 21

Patients have individual rights that cannot be parted with and derogated from, such as

Answer 21

right to seek treatment abroad, obtain
accurate information, be reimbursed and effective non-discriminatory access to preventive care to name a few.

Question 22

in the context of cross border healthcare we end up having both …

Answer 22

Regulation 883/04 over social security and Directive 2011/24 covering application of cross border healthcare.

Question 23

What are the differences between Regulation 883/04 and Directive 2011/24

Answer 23

The regulation serves free movement law and only concerns medical treatment delivered in the context of the national healthcare
system. The entire process is subject to th e law of the country of stay, hence prior authorization procedures are the rule.

The Directive instead is aimed at securing the reception of cross-border healthcare services and it is applied independently of
the service provider, as it harmonizes the rules relating to prior authorization and reimbursement, the level of which is limited to
that applicable in the Member state of affiliation.

For the directive the prior authorization is the exception and can only before seen to secure sufficient and permanent access to a balanced range of high quality treatment and when the cost of the treatment is quite high or when it poses a threat to the patient’s health.

All in all, the scheme of prior authorization is strongly pushed by the Regulation, while the Directive aims at being a softer
instrument to harmonize the rules governing cross-border healthcare across Member States. The Directive would perhaps be more
desirable, also for the fact that it attempts to live aside the prior authorization scheme for the very grave necessary situations,
which will involve a considerable amount of money and thus a possible clash between the two member states involved perhaps

Question 24

Reimbursement cannot be denied in three occasions according to the directive:

Answer 24

1) if the individual is entitle to the benefit in kind in the Member state
2) If there is a risk for the patien
3) If the treatment can’t be provided at home with a time limit which is medically justifiable.

Question 25

What is the difference in authorizations schemes between private and hospitals

Answer 25

in order to get hospital treatment there are authorization schemes in place, but they are not in place when we talk about private medicine. All this is derived from an interpretation of free movement of services established in article 56.

Question 26

How to bridge the gap between what has been established by the regulation and the directive?

Answer 26

The ECJ claimed that the
Regulation only contain an administrative mechanism aiming at facilitating the reimbursement of cross border healthcare costs, while the Directive aims at harmonizing patient rights in cross-border matters and could be relied upon as a sort of fallback
option when the tariffs are higher in the your residing member state, or when the prior authorization is not given. In the end there
is a freedom of choice to what the individual can decide to use in case of cross-border healthcare, that will depend mainly on the
tariffs applied. With the regulation the paid tariffs would be from the home state, while with the directive the ones from the state
of treatment would apply.

Question 27

What is the importance of the Veselibas case ?

Answer 27

The judgement brings forward the issue of giving a social and cultural dimension to healthcare in the EU, while at the same time
not forcing the hand of the MS in this situation, as it leaves a leeway to the national judge in the evaluation of the compliance of
the denial of the authorization within the boundaries of EU law.

The case is very important because it opens up a new dimension in the healthcare and health management sector, as even though
not directly inscribed in the Directive, states shall keep in mind their organizational responsibilities and the rights to observe
one’s religious belief when applying the Directive on patients’ rights and deciding on the healthcare allocation, both medically
and economically wise.

Question 28

What was the final decision in the Vaselibas case:

Answer 28

The final decision of the Court, based exclusively on the principle of non-discrimination in art. 21 of the Charter, establishes that the Regulation does not preclude Member States from refusing the prior authorization on matters of religious beliefs, but the Directive does preclude them from this refusal, unless it is objectively justified by a legitimate aim, is appropriate and necessary.

Question 29

What was the final decision in the Vaselibas case:

Answer 29

The final decision of the Court, based exclusively on the principle of non-discrimination in art. 21 of the Charter, establishes that the Regulation does not preclude Member States from refusing the prior authorization on matters of religious beliefs, but the Directive does preclude them from this refusal, unless it is objectively justified by a legitimate aim, is appropriate and necessary.

Question 30

The main legal risk arising from telemedicine is

Answer 30

Malpractice, because many many
times medical professional are required to be in the same room in order to have a better understanding of the patient they are
treating.

Question 31

When talking about E-Health at the moment there are only two available electronic cross-border health services:

Answer 31

the prescription of eDispensation, such as the online transfer of electronic prescription from country to country and the availability of patient summaries, which include information such as allergies, current medication, previous illness, surgeries, medical images, lab
results…. The giving of information is very very important, for matters of transparency because the more information are
provided the better the system will work.

Question 32

Electronic health record systems may be placed on the market or put into service only if they comply with several requirements such as:

Answer 32

• market surveillance authorities
• quality and transparency obligations
• common specifications
• technical documentation
• information sheets
  -and, most importantly perhaps, they comply with a declaration of conformity and present a CE marking.

Question 33

The EHDS is a big plan because :

Answer 33

• It involves directly the internal market and competition law
• it will require not only harmonization at EU level, but regulating the internal market inside member states, and this is the reason why it has been much more complicated to apply, requiring a strong will and consent by Member States to dive into the digitalization of healthcare.

Question 34

The interoperability of M- Health with an Electronic health record system would mean the compliance with :

Answer 34

• the essential requirements laid down in Annex II; in fact the label shall indicate the categories of electronic health data, a reference to common specifications and a validity period of the label
  ( max 5 years).

Through the label thus consumers can attest the quality of the app, and the producers of m-health apps can realize its full potential and constantly increase the quality and perhaps the scope of these apps.
The Commission shall establish and maintain a publicly available database with information on wellness application for which a label has been issued, and additionally there will be a market surveillance authority checking the compliance with essential requirements set for the award of the label, ensuring that the app is not watered down and worsened in time.

Question 35

Telemedicine would require an

Answer 35

innovation-friendly environment and thus costefficiency, interoperability between tools, funding, fixing the inadequate IT infrastructure.
Telemedicine requires coordination
with Medical Device Regulation, and all the other regulations involving health and the sharing of data of course. You have to pick the services that would work with telemedicine, as physiotherapy would not be possible to do online, but maybe psychology could be
practiced via a computer.

Question 36

how could telemedicine be included in EU law?

Answer 36

the choices would be to amend either Directive 2011, including telemedicine, or
Directive 2005 including e-health in Annex V on minimum knowledge, skills and training subjects. It could even be added to the Proposal of the European Health Data Space to article 8, saying “if a Member State
accepts the provision of telemedicine services, it shall, under the same conditions, accept the provision of similar services by healthcare providers located in other Member States”. However the last solution has already been abandoned and put aside by the European Commission because envisioned as too problematic.

Question 37

The European data strategy aims to…

Answer 37

make the EU a leader in a data driven
society, by creating a single market for data allowing it to flow freely from within the EU and across sectors fro the benefit of business,
researchers and public administration.

Question 38

In health for example, the European Health data space will

Answer 38

facilitate non-discriminatory access to health data and the training of artificial intelligence algorithms on those datasets.

Question 39

Digital sovereignty describes

Answer 39

a party’s right and ability to control its own digital data. It includes control over a company’s digital environment, concluding customers and employee data, software, hardware and other digital assets. The notion of digital sovereignty has recently emerged as one of the entryways for Europe to become a leader in the digital field. Digital sovereignty
for the EU thus refers to Europe’s ability to act independently in the digital world, understood both in terms of protective and offensive mechanisms to foster and improve digital innovation, and at the same limit its dependance from other actors in the field,
such as China and the USA.