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CONTENTS AN ASSESSING DOCTOR AS AN EMPLOYEE OF AN OCCUPATIONAL MEDICINE SERVICES PROVIDER? 

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OTHER HEALTHCARE LAW AMENDMENTS PLANNED 

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AMENDMENT TO THE ACT ON THE SCOPE AND CONDITIONS OF COVERAGE OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND DIETARY FOOD THROUGH PUBLIC HEALTH INSURANCE |6| AMENDMENT TO THE ACT ON MEDICINAL PRODUCTS AND MEDICAL DEVICES |7| CONTACTS

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AN ASSESSING DOCTOR AS AN EMPLOYEE OF AN OCCUPATIONAL MEDICINE SERVICES PROVIDER? As the transitional period in which employ-

the employer’s obligation to ensure OMS

ployment relationship. A breach of this

ers are not required to comply with the

via a sole provider (on the contrary, it as-

statutory obligation involves a risk of high

new Specific Medical Services Act draws

sumes such services to be provided by

penalties imposed by the Labour Inspec-

nearer, the concerns of some employers

several providers), it can be implied that

tion on the employer (in this case, the OMS

and occupational medicine services pro-

the employer may arrange for the OMS

provider performing OMS under an agree-

viders are growing over how to set correct

be provided by several OMS providers.

ment with the employer) and the employee

rules for their collaboration in assessing

This is particularly practical for employers

(the OMS subcontractor – the assessing

the state of health of current and potential

that have a large number of employees or

doctor). The reason why the performance

employees. Some of the related issues are

workplaces located in different parts of the

of an assessing doctor’s activities could

addressed in this article.

country.

be, in theory, considered employment is the fact that an assessing doctor performs

Although the transitional provisions of Act

In addition, there are no express provisions

his job solely in person and according to

No. 373/2011 Sb., on Specific Medical

in the Medical Services Act regarding the

the instructions of the OMS provider, as

Services (the “Medical Services Act”),

possibility of an OMS provider to transfer

employees are examined within the scope

state that occupational medicine services

its obligations arising from the agreement

stipulated by the provider. The activities of

may be provided in compliance with ex-

with the employer to another OMS provid-

an assessing physician accomplish some

isting laws, this possibility will be lost by

er by means of an agreement. Again, the

of the fundamental elements of employ-

employers with effect from 1 April 2013.

general principle of law will apply, stipulat-

ment (personal performance of the work

The deadline draws nearer while a great

ing that whatever is not prohibited is per-

by the employee according to the employ-

number of employees are faced with cer-

mitted, and will be applied in practice. The

er’s instructions). OMS providers who wish

tain ambiguities arising from the new rules

Medical Services Act does not prescribe

to delegate, under an agreement, some of

in the Medical Services Act.

under which contract the OMS provider

their activities to assessing doctors that

that has no employment contract with the

are not their employees are concerned

One of the issues currently addressed by

employer is to examine the employees’

that such an arrangement would be con-

employers is the provision of occupational

health condition. It is very easy to say that

sidered a ‘švarcsystém’. However, we are

medicine services (“OMS”) by means of

the contract between the two providers

of the opinion that such concerns can be

an agreement made between an employer

can be a commercial contract but the an-

quite easily dispelled.

and an occupational medicine services

swer to this question is not that simple, be-

provider (i.e., such occupational medicine

cause the provisions of the Labour Code

In general, we can state that if other ele-

services where the report of an employ-

(Act No. 262/2006 Sb., as amended) must

ments are not accomplished and the as-

ee’s registering doctor is not sufficient). Is

be taken into account as well.

sessing doctor performs his activity on

the employer required to contract a sole

his own behalf and responsibility (as the

provider of occupational medicine to pro-

If the subcontractor of an OMS provider

holder of a licence to provide medical ser-

vide all OMS to the employer? And is the

contracted by the employer is an individual

vices), at his own expense (using his own

OMS provider required to ensure that the

(a doctor assessing a patient’s state of

equipment and employing a nurse), out-

employees’ health conditions will be as-

health), it is inevitable to avoid the relation-

side the workplace of the OMS provider

sessed solely by doctors that are in an em-

ship between the two providers being con-

for whom the activity is performed (i.e., in

ployment relationship with the employer,

sidered what is known as a ‘švarcsystém’,

his own office), during hours determined

or can the OMS provider’s obligations be

where work is performed under a commer-

by him (not following the working hours

transferred to another OMS provider under

cial law contract instead of an employment

determined by the OMS provider), and in

a commercial contract?

agreement.

particular is not directly organisationally

Given the fact that the Medical Services

The Labour Code stipulates that employ-

cooperation is rather unlikely to be consid-

Act contains no express regulations as to

ment may solely be performed in an em-

ered as a ‘švarcsystém’.

subordinated to the OMS provider, such

Legal News Pharmaceutical Law

2

It should be pointed out that the determi-

be provided based on a contractual rela-

vided that the employer is required to en-

nation whether an assessing doctor’s activ-

tionship between the employer and the ser-

sure the professional independence of the

ity can be considered employment always

vice provider.

employees in points (a) and (b).

eration. Nevertheless, we can state that, in

In conclusion, we should briefly mention

From the perspective of de lege ferenda,

practice, OMS providers will definitely not

that a motion to amend the amendment

employers may provide occupational medi-

be forced to provide OMS to employers

to the Specific Medical Services Act (cham-

cine services via their employees. Never-

only via their employees. Especially con-

ber print no. 807) has been brought forward

theless, it is hard to imagine a scheme in

sidering the amount of penalties applicable

recently that is to permit employers licensed

which employers ensure the professional

to a ‘švarcsystém’, it is advisable that the

to provide medical services under the Medi-

independence of their employees in provid-

OMS providers pay special attention to and

cal Services Act in the a field under Sec-

ing occupational medicine services working

establish the contractual framework for col-

tion 54 (1) (a) or (b) to provide occupational

in practice.

laboration with assessing physicians that

medicine services for work performance in

will act as subcontractors for such activi-

their workplaces via:

depends on the specific terms of the coop-

ties, so that the above-described elements of employment are not accomplished and

a)

everything is done in compliance with the

qualification in occupational medicine or

law. This means particularly Article 10

specialised qualification in general medi-

of the International Labour Organisation’s

cine;

a

doctor

having

specialised

Occupational Health Services Convention No. 161 (Czech Decree No. 145/1988

b)

Sb.) that requires that occupational health

pating in the provision of occupational med-

services be fully professionally independ-

icine services;

Lenka Teska Arnoštová, Senior Associate

of the Medical Services Act, under which

with whom the employer has entered into

occupational medicine services may only

an employment or similar relationship, pro-

Eva Ostruszka Klusová, Associate

other healthcare workers partici-

ent from employers, and Section 54 (2)

Legal News Pharmaceutical Law

3

OTHER HEALTHCARE LAW AMENDMENTS PLANNED What is new about the draft amendments

application without the necessity to submit

to introduce a ban on advertising human

to the Life Sciences laws we introduced

any other documents. The re-registration

pharmaceuticals in the form of contest,

you to in our previous issues of Pharma

is to be requested of non-state healthcare

lottery or similar competition consisting in

News? And are there any other amend-

facilities by 1 January 2013.

the number of prescribed, consumed or

ments being prepared by law-makers? The most interesting information is sum-

dispensed pharmaceuticals, and a ban on Amendment to the Pharmaceuticals Act

marised in the following article.

providing, offering or promising bonuses in connection with dispensing prescription

In April of this year, Legal News present-

pharmaceuticals covered by public health

The previous issues of our Pharma News

ed the intention of the Health Ministry to

insurance; in addition, this amendment is

presented

amendments

bring forward an amendment to Act No.

also to impose stricter rules that apply to

and new regulations that would probably

several

draft

378/2007 Sb., on Pharmaceuticals. The

sponsored meetings and congresses of

deserve amendment or the adoption of

amendment is to prevent customers who

medical professionals. Even this proposal

a statutory instrument due to their prob-

acquire medicines as pharmacy opera-

(published as chamber print no. 761) has

lematic application in practice. What pro-

tors from distributing the medicines further

not been put on the agenda of the Septem-

gress has been made in this respect in the

without holding a licence to distribute phar-

ber meeting of the Chamber of Deputies

meantime? And what are the Life Sciences

maceuticals. The government-proposed

and will not be discussed until the end of

issues currently being discussed by the

amendment was tabled in the Chamber

October at the earliest

Parliament or the Ministry of Health?

of Deputies and ordered to be discussed

Re-registration of medical facilities

by the Healthcare Committee as cham-

Mandatory medical examinations for

ber print no. 783. Although it was to be

new employees

discussed by the Chamber of Deputies The January Legal News highlighted the

in September, the proposal has been re-

The amendment to Act No. 373/2011 Sb.,

ambiguities of the transitional provisions

moved from the agenda of the meeting as

on Specific Healthcare Services (chamber

of Act No. 372/2011 Sb., on Healthcare

not discussable.

print no. 752), which is to result in remov-

Services, which deal with the essential

ing altogether the obligation of employers

elements of applications for a licence to

The aim of the proposed amendment is

to require all new employees to undergo

provide healthcare services submitted by

also to ensure better control of counterfeit

a medical examination, including those

healthcare providers that are registered

medicines and their adverse effects.

that are to work under an agreement to

under existing laws. However, it is now be-

perform work (in Czech dohoda o pra-

coming obvious from guidance notes No.

Amendment to the Advertising Regula-

covní činnosti) or agreement to complete

ZD15/2012 published by the Health Min-

tion Act

a job (dohoda o provedení práce), passed

formality for non-state healthcare facilities

The same destiny has so far awaited the

ties. As we reported in the June issue of

and administrative authorities will only re-

amendment to Act No. 40/1995 Sb., on

our Pharma News, the obligation to send

quire simply the filling in of details in the

Advertising Regulation. The amendment is

all employees before the commencement

istry that the re-registration will be a mere

its first reading in the Chamber of Depu-

Legal News Pharmaceutical Law

4

of their employment (or a similar relation-

job applicants are to perform work classi-

replace the existing Act No. 96/2004 Sb.,

ship established by agreements for work

fied as hazardous.

on Paramedic Professions. The bill has

outside employment) to entrance medical checks irrespective of the scope and na-

been published beyond the scope of the University hospitals

ture of their work and subject to the penalty

prescribed legislative procedure and made available for comments by the general

that such employee be considered unfit for

The amendment to the University Hospi-

public. Therefore, it can be assumed that

work, has placed an excessive burden on

tals Act, which is to introduce a new le-

the new law could reflect the requirements

employers in practice (or more precisely,

gal form of university hospital into Czech

of the paramedic staff itself and better suit

will place an excessive burden when the

law and whose principles were presented

the application practice requirements.

transitional period will expire on 1 April

in the June issue, has passed the inter-

2013 during which employers are per-

ministry commenting procedure and is to

mitted to proceed in compliance with the

be discussed in the Chamber of Deputies

existing laws). The proposal is now to be

once the comments are incorporated.

discussed by the Healthcare Committee. Amendment to the Paramedic ProfesAt the same time, the Chamber of Depu-

sions Act

ties has been presented with a parallel draft amendment (chamber print no.

The Health Ministry has published a bill on

807) that is to limit the mandatory medical

the conditions of obtaining, acknowledging

checks for those working under outside

and recognising qualifications for para-

employment agreements. The obligation

medic professions and activities related

would thus only apply to employers where

to the provision of healthcare that is to

Eva Ostruszka Klusová, Senior Associate

Legal News Pharmaceutical Law

5

AMENDMENT TO THE ACT ON THE SCOPE AND CONDITIONS OF COVERAGE OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND DIETARY FOOD THROUGH PUBLIC HEALTH INSURANCE On 28 September 2012, the National

that the prices for medicinal products,

whereby the status applicable before Act

Council of the Slovak Republic was de-

medical devices and dietary food are

No. 363/2011 Coll. came into force is re-

livered a governmental draft amendment

not higher than an average of the three

stored.

to the Act on the Scope and Conditions

lowest prices within the EU. The current

of Coverage of Medicinal Products, Medi-

legislation stipulates that a medicinal prod-

The Amendment intends to specify the

cal Devices and Dietary Food via Public

uct price set by a manufacturer or an im-

individual processes in more detail, sim-

Health Insurance and on the Amendment

porter may not exceed the second lowest

plify them, and eliminate administrative

and Supplement to Certain Acts, and

medicinal product price among officially

demands in such a way that it clarifies

amending and supplementing the Act of

set product prices in other EU Member

primarily the provisions regulating the pay-

the National Council of the Slovak Repub-

States.

ment of administrative fees for applications

lic No. 145/1995 Coll. on Administrative

filed under the Act.

Fees, as amended (the “Amendment”).

However, the legislator’s intention is that

The Amendment is proposed to come into

the prices for medicinal products, medical

force from 1 January 2013.

devices and dietary food continue to remain at one of the lowest levels within the

The aim of the Amendment is to introduce

European Union also after the Amendment

in the Slovak Republic a new, and accord-

is adopted.

ing to the Slovak Ministry of Health, also a more fair method of setting medicinal

As the explanatory report to the Amend-

product prices, which would reflect price

ment implies, the medicinal products des-

changes in other EU Member States and

ignated for mandatory vaccination are

exchange rate changes in such a way so

excluded from a special payment method,

Kamila Turčanová, Senior Associate

Legal News Pharmaceutical Law

6

AMENDMENT TO THE ACT ON MEDICINAL PRODUCTS AND MEDICAL DEVICES On 28 September 2012, the National

products for human use introduced into

Moreover, the Amendment imposes a bur-

Council of the Slovak Republic was deliv-

the European Union market, as the safety

den only on wholesale distributors of

ered a governmental draft amendment to

of medicinal products for human use can

medicinal products for human use, as

the Act on Medicinal Products and Medical

currently be identified only after they are

medicinal product manufacturing authori-

Devices and on Amendment and Supple-

registered and introduced into the market.

sation holders are not imposed with such a

ment to Certain Acts, prepared by the Min-

duty, which, in our opinion, results in non-

istry of Health of the Slovak Republic (the

Such changes also include, for example,

compliance with the requirement under

“Amendment”). The Amendment is pro-

laying down the terms and conditions of

the Directive to ensure control of the entire

posed to come into force from 2 January

the export of medicinal products for hu-

medicinal product distribution chain.

2013, except for certain special provisions

man use for medicinal product whole-

that will come into force later.

sale distribution authorisation holders,

Professional Events for Medical Doc-

namely the notification duty of medicinal

tors and Healthcare Professionals

The purpose of the Amendment is to trans-

product wholesale distribution authorisa-

pose Directive 2011/62/EU of the Europe-

tion holders, i.e., the duty to notify the

Another change proposed by the Amend-

an Parliament and of the Council of 8 June

State Institute for Drug Control (the “Insti-

ment is the clarification of the definition of

2011, amending Directive 2001/83/EC on

tute”) in writing, within 30 days before

a ‘professional event’. The current wording

the Community code relating to medicinal

starting to export medicinal products for

of the Act on Medicinal Products and Medi-

products for human use (the “Directive”),

human use, of their intention to export.

cal Devices, (as well as the Code of Ethics

as regards the prevention of the entry into

However, such a duty has already caused

of the Slovak Association of Research-

the legal supply chain of falsified medici-

displeasure among medicinal product

Based Pharmaceutical Companies) clearly

nal products, and to also make stricter the

wholesale distributors. Under the Amend-

prohibits pharmaceutical companies from

requirements for all the entities handling

ment, a medicinal product for human use

paying for spare time and relaxation ac-

medicinal products for human use, in par-

may be exported only provided that the

tivities for medical doctors and healthcare

ticular, for medicinal product manufactur-

Institute does not inform the medicinal

professionals but, however, does not pre-

ing authorisation holders and medicinal

product wholesale distributor, within 30

cisely define what events are permitted

product wholesale distribution authorisa-

days after the distributor filed the complete

and for what purpose.

tion holders.

notice in writing, that the medicinal product for human use cannot be exported. At the

The Slovak Association of Research-

Supervision Over and Limitation on the

same time, a medicinal product for human

Based Pharmaceutical Companies itself

Export of Medicinal Products for Hu-

use may be exported within three months

supports the proposal to clarify the defini-

man Use

of delivery to the Institute of the written no-

tion of a ‘professional event’, whereas it

tice of the intention to export the medicinal

also supports a standard that at least 80%

product for human use.

of a professional event must be of a non-

A significant change brought by the Amendment relates primarily to the su-

promotional professional, educational and

pervision over medicinal products for

However, in our opinion, the introduction

scientific nature. The remaining 20% may

human use, which is to be stricter after

of this “additional approval process” by the

include accompanying events at which

the Amendment is adopted.

Institute within 30 days after the distributor

promotion is permitted to the specified ex-

has filed the complete written notice of its

tent.

As set out in the explanatory report to the

intention to export can likely be viewed as

Amendment, laying down specific rules for

a restrictive measure that is in conflict with

Based on the foregoing, the Amendment

the supervision over medicinal products

EU law, considering in particular the fact

also defines a ‘professional event’ based

for human use is to achieve the protection

that such a measure is not adequate and

on the regulation of marketing activities of

of the public health system so as to limit,

appropriate for achieving the set goal and

the entities involved in the medicinal prod-

or prevent, adverse effects of medicinal

is not contemplated by the Directive either.

uct chain. The supplemented definition

Legal News Pharmaceutical Law

7

aims at clarifying the activities that may be

patients discounts, benefits or a complex

such marketing activities are currently

performed by individual entities set out in

of discounts and benefits.

permitted by the Act are the bonus fidel-

this Act. The definition of a ‘professional

ity systems applied in public pharmacies

event’ only relates to professional, scientif-

The Amendment is restoring the ban on the

aimed at just the most vulnerable group

ic or educational events that are designed

bonus fidelity system in public pharmacies,

of citizens, i.e., the patients. The objective

exclusively for healthcare professionals,

the aim of which is to remove the practices

of this Amendment is thus to also exclude

which may also include accompanying ac-

leading to an increased consumption of

this last exemption from the ban on promo-

tivities permitted by the Act on Promotion

medicinal products, including medicinal

tion in the sale of medicinal products.

and their time frame may not exceed 20%

products that may be dispensed without a

of the total time frame of the professional

prescription, so-called ‘over-the-counter’

event.

medicinal products. In this respect, the explanatory report to the Amendment only

Omitting a So-Called ‘Bonus Fidelity

gives a brief explanation implying that un-

System’

der medical rules, any method of promoting the use of medicinal products, mainly

There are also proposed changes in pro-

by making use of marketing practices, is

viding pharmaceutical care, of which the

inadmissible. The explanatory report fur-

most important is a proposal to omit the

ther states that the bonus fidelity systems

bonus fidelity system, i.e., the right of the

have no place in the current system be-

holder of the authorisation to provide phar-

cause the Act prohibits such marketing ac-

maceutical care to grant or promise the

tivities overall; the only exemption where

Kamila Turčanová, Senior Associate

Legal News Pharmaceutical Law

8

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november 2 0 1 2

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