The head of the Association of Producers and Suppliers of Medical Devices and Equipment Stanislav Lesnic accuses the Agency for Medicines and Medical Devices (AMMD) of abuse of power and non-transparence in the process of registering medical devices. On the other side, the Agency’s director Alexandru Coman says the suppliers of medical devices are in fact dissatisfied with the legal norms that took effect three years ago as these norms brought the chaos in the system to an end, but also cut suppliers’ profits.
Difficult registration procedure
Stanislav Lesnic admits that the problems appeared after the Law on Medical Devices was adopted in 2012 as this law is controversial, according to him. “The Agency for Medicines was given ground for influencing the market of medical devices. It was also offered instruments for controlling, supervising, authorizing, assessing and holding tender contests. Normally, it should be responsible only for supervision and monitoring, not yet for the organization of contests and selection of winners. In such conditions, those who question the Agency’s work are persecuted and exposed to blows at any moment,” stated Stanislav Lesnic. He said that a number of problems are encountered in the process of registering medical devices. Under an order issued by the AMMD, the medical devices are registered by the producers, which can empower the suppliers to do this based on a contract, but the procedure is difficult.
“We are not against the registration of these devices, but a simplified procedure is needed. Under the current norms, the medical devices must be registered within 90 days. This is a short term given that there are hundreds of such devices. Also, the producer’s package of documents must contain the specifications and other technical documents for the device. For example, the Japanese producers that presented already the compliance certificates are bewildered why the technical documents are also needed, especially because these are the producer’s commercial secret. Some of the suppliers that are members of the association met with the producer’s refusal and weren’t issued with the technical documentation. There are many non-registered medical devices. There are tens of cases when the devices are not registered owing to the absence of technical documents,” stated Stanislav Lesnic.
Illegal tax collection schemes
Stanislav Lesnic said administrative obstacles are created artificially with the aim of obtaining money from the suppliers. The quality verification services are expensive. A sum of 2,390 lei is paid for having a medical device examined. “There are hundreds of thousands of medical devices applying for registration and all this money goes to the AMMD. When we register the medical devices, we pay tax without being issued with a sales receipt. When we take the set of documents for verification, the documents are returned to us as there is no clear set of documents that must be presented and they do what they want. The whole registration procedure is regulated by an illegal order made by the AMMD, which wasn’t subject to legal appraisal and wasn’t published in the Official Gazette. The order is modified as the Agency’s director likes,” stated Lesnic.
AMMED’s position
Contacted by IPN, the Agency’s director Alexandru Coman said the accusations were made following an older misunderstanding. The suppliers of medical devices are dissatisfied because before the Law on Medical Devices was adopted in 2012, they acted as they wished. The law brought clear regulations that ran counter to the practices used then. “When the rules of the game are changed, somebody is disadvantaged. Any law is made to establish rules of the game so as to protect society from illegalities and ensure a balance between the interests of the private sector and of society. We are in the middle of this balance as we must see where the limit between these interests is. The regulations and the registration of medical devices are absolutely necessary in our country because the used medical devices must be safe, efficient and of a high quality. That’s why we instituted clear norms, as in all the civilized states,” said Alexandru Coman.
He also explained the procedure for registering medical devices. “This procedure is regulated by three Government decisions, while the money we charge for the examination of files (2,390 lei) is not a state tax. Given that experts are involved in the verification, this is not a large sum. A payment order is issued and the money is paid at the bank. Earlier, many of the suppliers had agreements with the hospital directors and sold the medical devices without determining their quality. Now all the purchases for public institutions are centralized and evidently not all of the 480 suppliers gain, while those who do not earn money feel disadvantaged,” stated Alexandru Coman.
Alina Marin, IPN
