Legal support of public-private partnership projects in healthcare and pharmaceuticals
Legal services (legal assistance) in support of public-private partnership projects in healthcare and pharmaceuticals.
Legal support of public-private partnership projects in healthcare and pharmaceuticals is an important area of practice for BRACE Law Firm.
Healthcare and pharmaceuticals are key areas of industry specialization for lawyers at BRACE Law Firm, in which we provide legal services to manufacturers and distributors of medicines, medical devices, dietary supplements, and other healthcare organizations on issues of Russian and international law.
Support of public-private partnership projects in healthcare and pharmaceuticals
The main legal act regulating the legal framework of public-private partnerships is Federal Law of July 13, 2015, N 224-ФЗ “On public-private partnerships, municipal-private partnerships in the Russian Federation and amendments to certain legislative acts of the Russian Federation”, according to which public-private partnerships, municipal-private partnerships - this is legally executed for a certain period of time and based on pooling resources, sharing risks, public-private partnerships partner, on the one hand, and a private partner, on the other hand, which is carried out on the basis of an agreement on public-private partnership, an agreement on the municipal-private partnership, concluded in order to attract private investment into the economy, to ensure accessibility by public authorities and local authorities goods, work, services and improve their quality. Moreover, only a Russian legal entity can act as a private partner.
Within the framework of state programs operating in Russia, it is planned, on the basis of public-private partnerships, to ensure the creation of the necessary infrastructure, as well as the formation of the scientific, technological, industrial and human potential, as well as the information infrastructure of the pharmaceutical and medical industries.
Public-private partnerships and concession agreements
In fact, the concession agreement, as well as the state-private partnership agreement, is also an additional type of agreement aimed at attracting private investors to the state-regulated economy.
According to the concession agreement, the concessionaire is obligated to create and (or) reconstruct the property defined by this agreement, the property right to which belongs or will belong to the concessor, as well as carry out activities using (operation) of this property, which is provided to him for this purpose in the possession and use for a period specified by the agreement. Moreover, despite the fact that the subject of the concession agreement is narrower in comparison with the possible subject of public-private partnership, in contrast to the agreement on public-private partnership, a foreign legal entity may act as a concessionaire. In addition, another main difference between a public-private partnership and a concession agreement is that the ownership of the object of the public-private partnership may arise from a private partner, and under the concession agreement, the object remains with the concessor.
Both in the case of concluding an agreement on public-private partnerships and in the case of concluding a concession agreement, a detailed analysis of their conditions is required, as well as the participation of a lawyer in negotiations when resolving disputes between partners.
The specifics of public-private partnerships in healthcare and pharmaceuticals
Work in the framework of public-private partnerships in the areas of healthcare and pharmaceuticals has its own specifics. This is due to the fact that the introduction of the functioning of these areas of work of private companies should not only lead to the effective implementation of the project but also ensure its return on investment. Moreover, the circulation of medicines, as well as health issues in the Russian Federation, are subject to special regulation. For example, to conclude an agreement on public-private partnerships in the pharmaceutical field, it is necessary to take into account the specifics of manufacturing, clinical trials, registration, price regulation in the Russian pharmaceutical market.
For these purposes, it is important to elaborate on the general concept of public-private partnership, as well as to conduct a comprehensive market analysis to assess the prospects of the constructed financial and legal models.
In addition to the competent development of a business project, it is necessary to conduct timely and competent monitoring of its implementation. This is due to the fact that public-private partnership includes not only the legal relationship between partners but also requires the implementation of the terms of the public-private partnership agreement.
- Legal advice on concluding public-private partnership agreements and concession agreements in the field of healthcare and pharmaceuticals
- Legal assistance in developing the concept of public-private partnership
- Legal support in the implementation of public-private partnership agreements and concession agreements in the field of healthcare and pharmaceuticals
- Legal support in negotiating between partners of a public-private partnership or concession agreement
- Development and legal examination of public-private partnership agreements and concession agreements and other documents related to the implementation of public-private partnership projects in healthcare and pharmaceuticals
- Preparation of draft documents required to support public-private partnerships in healthcare and pharmaceuticals at all stages of their implementation
- Other legal assistance