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
The use of AI and machine learning solutions in drug manufacturing technologies with the use of machine learning and quantitative, high-throughput in vivo experiments; the EU regulations for advanced therapy medicinal products (ATMP) and the procedures for placing the most modern drugs on the world market by the European Medicines Agency.
The intensive development of medicine affects the
medical regulatory law in the European Union, which should cover more and more
new legal problems related to the increasingly common application of advanced
solutions of artificial intelligence, machine learning, telemedicine solutions
and cyber solutions to the technology of manufacturing medicinal products.
In the current legal status, however, the legality of
the use of such state-of-the-art AI and machine learning technologies in pharmaceutical
production should be assessed on the basis of the regulations on the assessment
of their final effect, i.e. the level of admissibility of placing ready-made
alternative therapy products on the market, as well as the legal aspects of
commercialization of such technologies.
Laboratory research in science and medical setting.
The 26th of May 2021 will mark the first day that the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (later ‘Regulation 2017/745’) will fully apply after the 4 years transitional period. This regulation concerns medical devices – that are also regulated in Poland in the Medical Devices Act of 20 May 2010 (later MDA).
Medicinal Products, on the other hand, are regulated in Poland in the Pharmaceutical Law Act of 6 September 2001 (later PLA). Medicinal products are also regulated by the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (later ‘Directive 2001/83/EC’) and the Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (later ‘Regulation 726/2004’).
Article 117 of the Regulation (EU) 2017/745 introduces significant changes for some combination products.
