Transfer of the Marketing Authorization to a Medicinal Product
Legal transfer of the marketing authorization to a medicinal product
With the development of the pharmaceutical market, as well as due to the instability of economic processes, many pharmaceutical companies have a need to redirect investment funds, start or stop activities in a particular state, as well as to acquire and sell pharmaceutical businesses.
However, the process of production and/or distribution of medicines is very complex and, in this regard, the sale of a pharmaceutical business requires mandatory contractual settlement and represents a set of transactions and legally significant actions, including the interaction of both the parties to the sale of the business, and interaction with authorities.
Using the example of the sale of rights to a medicinal product, it is necessary first of all to determine the type of medicinal product and the requirements for it (whether it is classified as an essential drug, whether it contains narcotic drugs, in which state it is registered, etc.). It is important to note the following aspects of the sale of such a transaction:
- transfer of rights to the pharmaceutical business under corporate law (purchase and sale of shares in a pharmaceutical manufacturer/distributor);
- transfer of a registration certificate for a medicinal product;
- transfer of patent rights to a drug;
- transfer of trademark rights;
- transfer of rights to production technologies;
- transfer of assets necessary for the functioning of the pharmaceutical business;
- analysis of obligations transferred as part of the sale of rights to a medicinal product
- analysis of tax risks;
- other legal aspects.
In particular, when selling an enterprise as a property complex, the parties conclude an agreement on the sale of the enterprise. In accordance with Art. 559 of the Civil Code of the Russian Federation, the seller transfers to the ownership of the buyer all the property of the enterprise, with the exception of rights and obligations that he cannot transfer to other persons. According to the general rule of this article, the exclusive rights to the means of individualization of the enterprise, products, works or services of the seller (commercial designation, trademark, service mark), as well as the rights belonging to him on the basis of license agreements to use such means of individualization are transferred to the buyer, unless otherwise provided contract. Thus, in the contract of transfer or a separate contract for the transfer of exclusive rights, it is necessary to specify all the conditions for such a transfer.
It is also important to pay attention to the fact that, according to the general rule of the above article of the Civil Code of the Russian Federation, the rights of the seller, received by him on the basis of a permit (license) to engage in the relevant activity, are not subject to transfer to the buyer of the enterprise. Thus, the buyer of the pharmaceutical business will have to obtain a license to carry out pharmaceutical activities in advance, if the specified one has not been obtained earlier.
Trademark rights can also be transferred through various transactions. For example, on the basis of a license agreement (on terms of full or partial use), an agreement for the complete transfer of IP rights, a franchising agreement, etc. The transfer of IP can be carried out on the basis of the above agreements. At the same time, it is important to note such aspects as the need to obtain the consent of all patent holders (including monitoring the entire chain of transfer of rights to a patent).
In all cases, after the transfer of rights to a patent and / or trademark, it is necessary to apply to the Federal Service for Intellectual Property.
Also, special attention should be paid to the transfer of the registration certificate for the medicinal product. Order of the Ministry of Health of Russia dated December 13, 2016 N 959n approved the classification of changes made to the documents contained in the registration dossier, according to which the main changes in the registration dossier may include:
- change of the name, legal form and (or) address, contact information of the holder or owner of the registration certificate; change in the name, legal form, contact information of the manufacturer of the medicinal product;
- exclusion of one or more participants in the manufacturing process, or replacement or addition of one or more participants in the manufacturing process of the medicinal product.
Methodological recommendations of Federal Service for Surveillance in Healthcare for work with labeled medicinal products establish the procedure for the subject of medicines circulation to change the holder of the registration certificate for a medicinal product for medical use in the System of Monitoring the Movement of Medicinal Products. This procedure includes registration of a new holder in System of Monitoring the Movement of Medicinal Products and conclusion of an agreement for payment for marking codes, direct marking.
Thus, the transfer of the marketing authorization to a medicinal product includes the changes in the registration dossier, as well as the registration of a new owner in the System of Monitoring the Movement of Medicinal Products system.
It is also impossible not to pay attention to the fact that within the EAEU a technology transfer procedure has been introduced, which includes the transfer to the receiving party of documented information and experience gained during the pharmaceutical development and (or) release of medicines, including the transfer of documentation, information about production processes, skills and knowledge from the transferring side. With the introduction of the legal acts of the EAEU into the Russian jurisdiction, we believe that issues and legal norms related to technology transfer will also be affected when conducting transactions with the sale of rights to a medicinal product.
Based on the foregoing, we can conclude that transactions for the transfer of rights to medicines are complex and require a detailed study of all aspects related both to the relationship of the parties to the transaction and compliance with the requirements of public law (in terms of registration and labeling of medicines, as well as transfer of exclusive rights).
- Advising on the transfer of the marketing authorization to a medicinal product
- Participation in negotiation processes related to the transfer of the marketing authorization to a medicinal product
- Development of a strategy for concluding transactions
- Legal support when reissuing a registration dossier for a medicinal product
- Development of agreements aimed at the transfer of IP rights to a medicinal product
- Preparation of sales contracts for a pharmaceutical company
- Analysis of tax risks in the transfer of pharmaceutical business
- Legal assistance in settling corporate law issues related to the transfer of the marketing authorization to a medicinal product