INTRODUCTION TO THE MARKET OF BIOCIDAL PRODUCTS IN POLAND IN THE LIGHT OF EUROPEAN UNION REGULATIONS IN THE ASPECT OF GENETICALLY MODIFIED ORGANISMS
DEFINITION OF BIOCIDES
GENETICALLY MODIFIED INSECT TO CONTROL NATURAL POPULATION AS A BIOCIDAL PRODUCT
Legal
definition of the term “biocidal product” placed on the market is
obvious. This definition is provided in Article 3.1 of the Regulation (EU) No
528/2012 of the European Parliament and of the Council of 22 May 2012. Under EU
law, a biocidal product is, in principle, “any substance or mixture, in
the form in which it is supplied to the user, consisting of, containing or
generating one or more active substances, intended to destroy, deter, render
harmless, prevent the action of, or otherwise exert a controlling effect on any
harmful organism by any means other than mere physical or mechanical action
(…)”.
Thus, in
relation to the basic core of the legal definition, a biocidal product is therefore
understood as a product with a basic biocidal function.
This issue
is also addressed by the Polish Act of 9 October 2015 on biocidal products. It
mainly stipulates the conditions for using and making biocidal products
available on the Polish market and the authority responsible for the
application of Regulation 528/2012, i.e. the President of the Office for
Registration of Medicinal Products, Medical Devices and Biocidal Products.
FIRST GENETICALLY MODIFIED MOSQUITOES IN THE USA
A very interesting example of the introduction of genetically modified organisms is the mosquito released in the United States, on which the biotechnology company Oxitec conducted research. It was about a ten-year battle for permission to carry out the experiment. The main reason for such a long process were the protests of Florida residents who feared the bites of the new insects and the disruption of the ecosystem. The whole experiment involves releasing a bioengineered male mosquito to copulate with wild females, which transmit many diseases through their bites, including yellow fever, dengue and the Zika virus.
The Polish draft law on clinical trials of
medicinal products for human use was sent for public consultations on 30 April 2021
and is still waiting for the final wording.
This project aims to bring the current
legislation into line with the Regulation of the European Parliament and of the
Council on clinical trials on medicinal products for human use, which aims to
ensure the safety of people who take part in clinical trials, to simplify and
speed up the authorisation procedures for such trials, which are a key part of
the process of developing new medicines and improving treatment with existing
medicines.
The bankruptcy cases are regulated in Poland majorly by the Insolvency Act of 2003 (in Polish: Ustawa z dnia 28 lutego 2003 r. Prawo upadłościowe (t.j. Dz. U. z 2020 r. poz. 1228 z późn. zm.)) (later: ‘Insolvency Act of 2003’). Yet it is not the only applicable regulation. In cases of cross-border bankruptcy proceedings or cases where a Polish citizen is adjudged bankrupt in the territory of the Member State of the European Union or Ireland, the bankruptcy proceedings are regulated by the Regulation (EU) 2015/848 of the European Parliament and of the Council of 20 May 2015 on insolvency proceedings (OJ L 141, 5.6.2015, p. 19-72) (later: ‘Regulation 2015/848’).
On May 12-13, 2021, Małgorzata Kiełtyka and Jakub Gładkowski from KG LEGAL Kiełtyka Gładkowski participated in IMPACT’21.
Energy transformation, green economy, the National Reconstruction Plan, the development of local e-commerce, the prospects of the banking sector and the expansion of digital banking were just some of the topics discussed during the event. Speakers talked about the health care system, the development of the cryptocurrency market and cybersecurity. As part of the paths: Sport and Art, it was possible to talk about the management and economic realities of the Polish sports sector as well as investment trends in art in Poland. In a separate path entitled Women Empowerment there was discussed the role of women in business and the fight against discrimination. In terms of the digital future, the speakers talked about technological innovations in 2021, the impact of 5G on the global economy and the issue of whether Asia will remain a key player in the race of technological innovations.
On June 3, 2021 KG LEGAL KIELTYKA GLADKOWSKI will participate in a webinar, organized by Jones Day, devoted to EU plans to Regulate AI: “Sweeping EU Proposal to Regulate AI: A New Global Standard?”
The lawyers of Jones Day organize a roundtable discussion with European Commission and corporate and public policy representatives that will explore the global implications of the recent EU proposal to regulate artificial intelligence (AI).
