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Blog home > PHARMACEUTICAL, HEALTHCARE & LIFE SCIENCES LAW > DUE DILIGENCE CLAUSES IN LABORATORY EMPLOYMENT AGREEMENTS AND THE LEGAL CONSEQUENCES OF VIOLATING THEM VS. GOOD LABORATORY PRACTICE

DUE DILIGENCE CLAUSES IN LABORATORY EMPLOYMENT AGREEMENTS AND THE LEGAL CONSEQUENCES OF VIOLATING THEM VS. GOOD LABORATORY PRACTICE

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

On the grounds of domestic legislation, the issue of GLP is regulated in the Regulation of the Minister of Health of 22 May 2013 on Good Laboratory Practice and the performance of research in accordance with its scope. Annex I to the Regulation defines the standards of work required of the manager of a research center, the study director or members of the research staff. Attention should be paid to the last two categories, since the work standards specified for them determine the scope of diligence to which the employee may be obligated in a contractual clause. According to section 2(6) of the Annex to the said Regulation, the members of staff should be knowledgeable about the GLP of the specific research being conducted. They are required to act on the basis of the study plan and instructions contained in the documents, and to accurately record data obtained from the studies. Each employee should take care of his/her own safety and that of the environment, and report any deterioration of his/her health to his/her supervisor for the purpose of the possible removal from the study. Additional responsibilities are placed on the study supervisor as the person responsible for coordinating the team. These include, but are not limited to: overseeing the study and ensuring that it is conducted with care and accuracy, accepting the plan, and ensuring that adequate copies of the plan are available for the team to rely on when conducting the study. 

Employee actions are subject to constant scrutiny – any deviation from work standards and failure to follow GLP principles is documented and reported to the study director, according to the Regulation. This may result in various consequences for the employee, such as reprimand, disciplinary responsibility, or even termination of employment contract. The detailed rules of an employee’s liability for a breach of due diligence are always defined in an individual contract constructed for them. It is worth mentioning, however, that omissions of individual employees may negatively influence the outcome of an inspection of the entire testing unit by the Inspector of Chemical Substances – the body appointed to inspect testing units at the national level.

European solutions

The basis of the Regulation of the Polish Minister of Health is to be found in the EU legal acts, which have been implemented into Polish law. Therefore, it should not be surprising that the regulations contained in the acts (created before 2013) do not differ significantly from those adopted in the Regulation. The first of them, Directive 2004/10/EC of the European Parliament and the UE Council from 11 February 2004 in Article 1 imposes on Member States the obligation to ensure that laboratories conducting tests on chemical products act in accordance with the principles of the GLP act and the Directive of 1967 on the classification, labelling and packaging of dangerous substances (67/548/EEC). Annex I of the 2004 Directive defines GLP as a quality system that relates to the organizational process and conditions under which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, archived and reported. It has been determined that the purpose of the establishment of the GLP is to take care of the quality and conditions under which non-clinical safety studies for health and the environment are carried out for the registration or authorisation of products such as pharmaceuticals, pesticides, veterinary products, industrial chemicals or food additives.

Key issue is the regulation set out in Section II, para. 1.4. of the abovementioned act, which constitutes the duties of research personnel. It imposes on personnel the obligation to know the GLP principles applicable to a particular study being conducted. It orders the personnel to act on the basis of instructions included in study documents, as well as to maintain health protection measures in order to care for the environment and their own safety. The duties of the study director set forth in this act are similar to those of the Regulation of the Polish Ministry of Health, namely such a director is responsible for supervising the diligent performance of personnel, approves study programs and instructions, and certifies that qualified personnel, familiar with GLP principles and the study plan undertake their duties.

The issue of control of research units, and consequently – their employees and their compliance with GLP principles, was regulated in Directive 2004/9/EC of the European Parliament and the EU Council of 11 February 2004. It stipulates that Member States shall appoint national inspection authorities to supervise the operation of entities in accordance with the principles of professional diligence. If irregularities are detected in the implementation of GLP principles in a given unit, and employees show ignorance in the application of its principles, there will entail negative consequences (ranging from questioning the validity of the tests carried out by the unit to its removal or undertaking legal action). These consequences do not preclude additional action by the national authority, based on the specific rules of a given Member State.

It should not come as a surprise that employers in the laboratory sector are striving to enforce the highest possible degree of professionalism, accuracy and attention to professional duties from their employees – the specificity of the described branch requires the highest possible diligence in performing tasks and marginalization of mistakes, which may have serious consequences in the environmental and health dimension. EU and Polish regulations enable employers to effectively implement these obligations in the contract, with individual sanctions for failure to do so.

SOURCES:

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