medical and pharmaceutical industry has a long tradition. In recent years, its
structure and dynamics have changed significantly. The domestic pharmaceutical
industry is one of the strategic industries of the Polish economy. It plays a
key role in the whole healthcare system, providing Polish patients with examined,
effective, high-quality and affordable medicines. Most Polish pharmaceutical
companies have been privatized and numerous companies have been taken over by
large foreign pharmaceutical corporations. In addition, new successful
companies are emerging, which thanks to their innovation and implementation of
new technologies, are entering foreign markets and becoming competitors of
foreign companies. They also
contribute to a significant increase in the competitiveness of the Polish
The team of
KIELTYKA GLADKOWSKI dedicated to clients operating in life science sector
actively advises on all aspects of in vitro diagnostics, including regulatory,
corporate and investments matters. For the purposes of such clients this text
analyses the bullet points of REGULATION
(EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017on
in vitro diagnostic medical devices and repealing Directive 98/79/EC and
Commission Decision 2010/227/EU. Regulation 2017/746/EU (IVDR) replaces the existing
Directive 98/79 / EC on in vitro diagnostic medical devices (IVDD), which was
adopted in 1998.
publication of the IVDR, the five-year transition period from the In Vitro
Diagnostic Medical Devices Directive (98/79/EC) (IVDD) to the new regulation
has started. The IVDR regulation will apply from the date of application, i.e.
from May 26, 2022, with some provisions, including Notified Bodies and the
Medical Device Coordination Group will enter into force sooner. Until the date
of application of the IVDR, the laws and regulations adopted by the Member
States under the IVDD will continue to apply. Under Art. 22 of the 1998 IVDD
directive, the member states were obliged to prepare and introduce the national
laws, regulations and administrative provisions necessary to comply with this
directive by December 7, 1999 (IVDD) at the latest. The provisions of the
directive were to apply with effect from 7 June 2000. As the provisions of the
directive could be interpreted differently in different countries, it was
possible for national provisions to differ. In the case of EU regulations, the
provisions contained therein do not have to be transposed and adapted to
national law. In May 2017, the European Parliament and the Council of the
European Union published two new regulations on medical devices (2017/745/EU)
(MDR) and in vitro diagnostic medical devices (2017/746/EU) (IVDR). Regulation
2017/746/EU (IVDR) replaces the existing Directive 98/79/EC on in vitro
diagnostic medical devices (IVDD), which was adopted in 1998.
GLADKOWSKI is proud of the fact that we advise on regulatory matters concerning
the most modern pharmaceuticals and therapies in the world, including those
related to cell and gene therapies. We work for our corporate clients at all
stages of their development, from inception to IPOs.
We try to broaden
the knowledge necessary to understand the needs of our clients. An example is
the analysis of a report concerning the market and novelties of gene and cell
therapies in the United States. The purpose of this article is not to describe
specific diseases, but for the purposes of legal services, we focus in such
analyses on technologies and types of state-of-the-art therapies.
We invite you to
read the text containing specific examples, names of therapies, companies, etc.
This text is based on the report prepared by the STAT organization, which is a premium
subscription service for in-depth biotech, pharma, policy, and life science
coverage and analysis. They focus on policy developments in the US, early
science breakthroughs and clinical trial results, and health care disruption in
Silicon Valley and beyond. The entire report can be reached here:
The future of
cutting-edge gene and cell therapies is changing novel approaches and changing
the trajectory of treating cancer, lethal genetic diseases and other
devastating diseases. But these innovations also come with their own set of
challenges, including access issues. The high prices of such therapies, which
have entered the market in recent years, and the expected high development
costs of others, raise questions about how healthcare systems, payers and
patients will pay for treatment.
FDA approves the first personalized cell therapy for
patients with: Multiple myeloma.
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.
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.
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.
one of those texts. We invite you to read it.