The Annual General Meeting will be held online, during which decisions will be made, among others, on the expanding cross-border cooperation and new opportunities to increase law firm legal services as part of participation in life science organizations of the association.
BioLawEurope F.m.b.A comprises a network of independent law firms, i.e. a collective number of licensed attorneys operating nationally under a common trademark or name, but not necessarily in the form of a corporation, and individual attorneys registered and licensed in one or more European jurisdictions and specialized in the rendering of legal services to commercial as well as non-profit based natural and legal persons, including universities and organizations operating, investing in and/or servicing biotech, pharma, food supplement, medical device and/or dentistry industry related.
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 concept of Standard Operating Procedures
(SOP) was initially used in the U.S. Army to describe a system of military
instructions that allowed the execution of orders in a systematic and
predictable manner. In subsequent years, the concept was implemented into
medical terminology, and now it is used in other fields that require for their
efficiency repetitive but effective instructions that allow rapid achievement
of the desired objective.
But what really is SOP? Practically
speaking, SOP is a system of planned instructions, procedures enabling an
entrepreneur to achieve a certain goal without additional complications. The
SOP should describe in simple steps the next steps of conduct in particular
situations that may occur to employees of various industries. It is important
that the steps are written in a clear and transparent way that does not cause
doubts to those who will have to apply it. Through repetition and detailed
description of important issues, SOP leads to standardization and improvement
of the application of the most complex processes occurring in companies. SOP
system does not only constitute support and facilitation for employees – it
also improves the work of business owners who, thanks to it, have a better
understanding of the processes taking place in entities and are able to more effectively
supervise and respond to operations carried out in companies.
DUE DILIGENCE CLAUSES IN LABORATORY EMPLOYMENT AGREEMENTS AND THE LEGAL CONSEQUENCES OF VIOLATING THEM VS. GOOD LABORATORY PRACTICE
What essentially is GLP?
The problem of regulating diligence clauses in employment contracts in the laboratory industry is essential on the basis of Polish and EU law. These issues shall also consider the general consequences of breaching employee obligations in the form of the so-called Good Laboratory Practice (GLP) principles.
For some time in the business turnover we can observe the practice of including in employment contracts clauses concerning professionalism and professional diligence in the actions of future employees. As a rule, the clause at issue imposes an obligation on the employee to perform their tasks in a professional manner, adequate to their position and in accordance with standard operating procedures. In addition, all actions of the prospective employee must conform to the recommendations and directives of the supervisor and comply with the applicable law.
The laboratory industry is no exception in this area. It imposes an obligation on employees and contractors to act not only diligently but also based on the principles of Good Laboratory Practice. These principles have been in place since 1978 and regulate issues such as quality assurance in drug testing and development, the prevention of pharmaceutical scandals, and ensuring performance standards for laboratory areas. In addition, the principles regulate such key issues as staffing, space requirements and the quality of equipment and inspection processes for laboratory areas.
Polish GLP regulation and the consequences of violating it
