The Polish Ministry of Health continues legislative work on a new draft law on medical devices. The original draft was presented during the previous term of the Polish Sejm. The law is intended to carry over the solutions of the EU Regulation 2017/745 (MDR Regulation) on medical devices which came into force at the end of May 2021.[1]
Advertising
medical devices
One of the most significant changes
is expected to be the introduction of certain restrictions on the advertising
of medical devices. First of all, advertising of products at fairs,
exhibitions, public presentations or scientific symposiums will be prohibited.
Sales representatives will not have the opportunity to visit physicians to
advertise their product to them. On the other hand, if a person cooperates with
the company and receives benefits from it, he or she will not be able to
recommend and pass on his or her opinion about the medical device to others. On
the other hand, trade catalogs or price lists containing only the trade name
and the price of a medical device are not to be regarded as product advertising.
The condition is, however, that they do not contain information referring to
the characteristics of the medical device or other information with promotional
purposes or leading to an increase in sales. In addition to the general
prohibition on misrepresentation under the MDR, under the Draft, advertising of
a device to the public will not permit the use of images of persons who are or
claim to be members of the medical profession or depict persons presenting a
device in a manner suggesting that they are members of such profession.
KIEŁTYKA GŁADKOWSKI KG LEGAL constantly supervises and prepares its lawyers for the specialization in which they provide services for foreign clients. In order to systematize the conceptual grid of very specialized fields of pharma, biology, medicine and life sciences as well as new tech in healthcare KIEŁTYKA GŁADKOWSKI conducts internal consultations to improve the experience of our lawyers specializing in legal assistance for foreign clients from life science and tech sector. As a result of such internal research, KIEŁTYKA GŁADKOWSKI creates and publishes texts on topics related to modern legal problems, but also to explain the basic concepts of specialized life sciences and pharmaceutical fields. In this way, KIEŁTYKA GŁADKOWSKI aims to demonstrate to potential clients within specialized industries that our lawyers are also familiar with specialist terms necessary for a proper understanding of our foreign client’s business and legal needs.
This is
one of those texts. We invite you to read it.
WARSAW
HEALTH INNOVATION HUB – THE BEGINNING OF THE POLISH MEDIAL VALLEY
On
June 10, 2021 there was launched the Warsaw Health Innovation Hub (WHIH). This,
first in the Eastern (and Central) Europe, initiative between public and
business sectors will bring together leading global medical, pharmaceutical and
biotechnology companies. According to the funders’ intention, it should be a
beginning of the Polish Medical Valley which was created concurrently with the
WHIH. The WHIH is intended to be just a first step of this huge, innovative
enterprise.
WHAT
IS THE WARSAW HEALTH INNOVATION HUB?
The
Polish WHIH is the first business initiative in the Central Europe that brings
together co-working between public sector with business entities in order to
create innovative medical, technological and legal solutions for patients’
health improvement and for enhancement the capability of Polish health- care
system. This unique conception (co-working conception) will allow to provide
the conditions for rapid transformation of ideas into products, processes and
services, taking into account the development interests of the Polish
biomedical sector and Poland’s need to be independent in terms of drug and
medical products safety. It is also an opportunity to invest in Polish
technologies and the best research teams in the country, according to the
Medical Research Agency.[1]
This
is a joint initiative between the Medical Research Agency (Agencja Badań
Medycznych)[2]
EIT Health[3]
and global medical industries players: AstraZeneca, Microsoft, Polpharma,
Roche. The launching ceremony was held at the Chancellery of the Prime Minister
of Poland with his patronage.
The main task of the Polish Platform for Handling Investment Projects (POPI)
is fast and accurate implementation of broadly understood investment projects,
which is (as the Polish Ministry of Health maintains) one of the most important
activities of the Ministry of Health. In order to bypass many entities that
would be involved in the implementation of a given investment, the Ministry of
Health brought to life the POPI platform, which automated the above-mentioned
process and thus facilitated navigation in the area of investment projects and
increased the number of investment projects implemented in the area of health.
The platform for servicing investment projects of the Polish Ministry of Health
is a place bringing together entities that are directly involved in the process
of launching investment projects. As part of this platform, entities can apply
for funds for any investment co-financed by the Ministry of Health.
Additionally, the POPI platform can function as a place where applications are
assessed, and the given investments are monitored and settled. It should also
be remembered that mutual contact regarding the implementation of specific
investments is also part of POPI.
The Investment Project Support Platform (POPI) is available at the
following address:
It is also important that in order to fully use the POPI platform, it is
required to set up an account through a certified profile, and to submit the
application with the use of a qualified electronic signature.
When we are currently witnessing a constantly changing environment, the phrase ‘food law’ or ‘agriculture law’ is not sufficient to describe the situation by legal terms. What can be observed in the market is that the food sector and new technologies sector have stepped up cooperation and co-work. Such new products as vegan meat, soya, coconut, almond milk, mechanic bees are a result of food-tech cooperation. The food tech cooperation comprises a considerable part of the market in Poland, effecting in the creation of a number of start-ups, such as for example:
Qurczak
which produces a unique plant- based alternative to poultry meat, made of fibers
that resemble chicken breast;
Frens
which produces a hypoallergenic and easily digestible food for dogs containing
insect protein;
KuMin.Sys
which is an IT tool for catering industry to help better plan production
volumes, optimization of costs and reduction of food waste.
The
above start-ups function in the Foodtech accelerator https://foodtech.ac.
This is one of the many examples of enhanced cooperation between food and
technology (especially IT) sectors. Behind these innovative ideas there is
always specific legal regulation which controls and moderates the business
reality.
POLISH
AND EUROPEAN FOODTECH LEGAL FRAMEWORK
In
Poland there are the following main legal acts which contain the relevant provisions
in the discussed sector:
