Preparation legal examination of internal policies (anti-corruption, antitrust, and others) for pharmaceutical companies and companies in the field of medical products

Amendments to the registration documents of medical devices

One of the important areas of legal services in the framework of the “Healthcare and Pharmaceutics” practice is the development and legal examination of internal policies for pharmaceutical companies and companies in the field of the circulation of medical devices:

In order to achieve new performance indicators of pharmaceutical companies and companies in the field of circulation of medical devices, the development of new markets and avoiding the risks of sanctions for violation of applicable laws, the need to improve internal control over the activities of business entities is of particular importance. Well-developed domestic policies form the main foundation for developing a harmonious and strategically correct course for pharmaceutical companies.

Company internal policy

Under the internal policy of a company is understood the fundamental principles adopted by organizations and the requirements for the implementation of their activities, which are mandatory for all employees and contractors to follow (when bringing to their attention data on the need for such compliance). Also, internal policies can determine the main criteria by which the quality of a company’s work is evaluated, and rules for the conduct and performance of work by employees can be established. An extremely important aspect is that this document can establish rules regarding the observance of ethical standards and the rules that play the role of preventive measures aimed at preventing the commission of offenses, conflicts of interest, etc.

In particular, the main types of internal policies of companies include anti-corruption policies, as well as antitrust. Consider the features of each of them in more detail.

According to the Methodological Recommendations on the development and adoption by organizations of measures to prevent and combat corruption, an organization’s anti-corruption policy is a set of interrelated principles, procedures and specific measures aimed at the prevention and suppression of corruption offenses in the activities of this organization. It is recommended that this document consolidate information on the anti-corruption policy implemented in the organization in a single document. It is important to note that the regulation of the application of anti-corruption measures by business entities is often not limited to the requirements of Russian legislation. In connection with active participation in the pharmaceutical market and in the market for the circulation of medical products of foreign companies, with the development of international relations, the need to assess compliance with the laws of other countries is of particular relevance. A special place in a number of legal acts of a transnational character is occupied by the US Federal Law on the fight against corruption (Foreign Corrupt Practices Act or FCPA), as well as the UK Bribery Act.

The issues of legal regulation of antitrust policy in the framework of Russian law are closely related to the introduction of antitrust compliance, which is understood as the system of internal ensuring compliance with the requirements of antitrust law, that is, the totality of legal and organizational measures provided for by an internal act and aimed at observing the requirements of antitrust law and preventing its violations. The introduction of antitrust compliance in the company is proposed to qualify as a circumstance mitigating administrative responsibility. The internal antitrust policy defines the main measures aimed at preventing and preventing violations of the requirements of competition law. In view of the foregoing, the need to develop antitrust policies by business entities is of particular relevance.

Legal services

    1. Legal advice on the development of internal policies (anti-corruption, antitrust, etc.) of pharmaceutical companies and companies in the field of medical devices
    2. Legal analysis of the internal policies provided by the client
    3. Development of internal policies for pharmaceutical companies and companies operating in the field of circulation of medical devices
    4. Legal assistance in resolving disagreements in the process of approving internal policies
    5. Legal support in the development and implementation of antitrust compliance in pharmaceutical companies
    6. Legal assistance in building a compliance control system

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