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 2017 on 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.

With the 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.

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KIELTYKA 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.

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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.

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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.

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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.

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