Directive 2011/62, repositories and Blueprint solution systems become important in the current vocabulary of the pharmaceutical sector. Additionally, Regulation 2016/161 includes provisions involving several changes in strategies and business structures, and the creation of entities to ensure compliance with the legislation and its proper implementation.
At an institutional level, the creation of a body to ensure the correct development of all the processes regarding medication is required. We refer to NMVO (National Medicines Verification Organization). To explain what NMVO is and how it will be in Spain, it’s necessary to know beforehand what EMVO is and does.
- Non-profit organization created at European level and made up by several stakeholders.
- Is responsible for establishing and managing the repositories systems at European level.
- Ensures interoperability of the connected systems.
- Concludes agreements with NMVOs (the homonyms bodies at national level).
- Define technical standards.
- Manages the Blueprint national systems.
So the NMVO will be the organization in each country to have these responsibilities and to handle the management of the repositories at a national level, and simultaneously, liaise with the European management body.
It is intended by the EMVO that the Blueprint system be adopted by the national systems of each country, but it’s important to state that it isn’t mandatory. Obviously, there are some interesting advantages by being a tested system and whose structure better adapts to the existing one at European level. On the contrary, the EMVO must facilitate Hub interfaces to ensure the interoperability with other repository systems, whatever they may be.
As for Spain, the implementation of the Spanish system contemplates three key aspects:
- How the model will work.
In this sense, the data that will be dealt with in the system must be defined, as well as the technical aspects of the system that will support them.
- The organization structure and management of the Spanish agency that deals with the system is.
The proposed organizational structure accommodates all actors involved in this market.
- How the funding model of the systems will be.
In principle, the pharmaceutical laboratories that commercialize serialized medicines in Spain will assume the cost of system implementation, as well as the yearly operations derived from this activity. Thus, it’s expected to provide specific credits for the implementation and charge a fee for the operational costs, that will also have an upper limit, proportional to the billing in each case of these drugs.
In addition, and in order to comply with the goal of performing at maximum level in 2019, four implementation phases have been established:
2015 Launch: the actors affected by the regulation met last year for defining the system requirements.
2016 Development: The company that will manage and define the definite requirements and implementation plan, must be established in this year.
2017 Pilot: A pilot project will be developed to try the defined system and to determine the necessary steps for its correct implementation.
2018 Implementation: during the year prior the official entry of the regulation,
2018 Implementation: during the year prior the official regulation comes into force, the pharmaceutical companies must progressively begin to trade their products with the unique identifier. Although it is not yet obligatory, this phase is necessary to verify that all the systems function properly.
Regarding drugs produced prior to February 9, 2019 and not incorporating the unique identifier, they can continue to be commercialized until their expiry date. This means that during a certain period of time, there’ll be a coexistence of different systems.
As for drugs that have occurred prior to February 9, 2019 and incorporated not bearing the unique identifier, may continue to be marketed until their expiry date. This means that for a while will be a period of coexistence of different systems.
In short, it seems that the phases and the actions that must be initiated are clearly defined, but there must be agreements in certain aspects in order to follow the roadmap, and avoid having to request any moratorium for the application of the norm.