Framework rules for artificial insemination units
Published on: 06/01/2016

Order and rules in the operational status of insemination units puts the state with more than ten years delay in order to protect public health and the thousands of citizens fleeing a year (over 15,000 couples) in vitro fertilization to have children.

The Council of State was lit "green light" to promote Presidential Decree project for Units establishing and operating conditions Medically Assisted Reproduction (MIYA), and a special licensing regime and regular checks of MIYA by the National Authority of Medically Assisted Reproduction (EAIYA).

Despite the provision of Law. 3305/05, over 10 years pending the DS that would define terms and consistent with operating conditions have not been thoroughly tested or licensed about 70 such units operating years in our country, and was forced to EAIYA dissolve before 3 years (due to the depreciation of the State) and was reactivated recently.

PD plan provides a set of technical standards, qualifications and operating conditions of MIYA needed to provide reliable services in order to avoid risks to the health of medically assisted women and to achieve the best possible outcome in IVF.

Legal PD

The State Council decided in principle legitimate plan PD because the organization and staffing of MIYA established appropriate and adequate legislative system control MIYA (public and private) in the framework of the constitutional requirement for the state to take measures to protect health of citizens.

However, the State Council has imposed corrections, judging marginally lawful (1 vote difference) transitional provision that allows laboratories that do not meet the new specifications (but with spaces and equipment to their proper functioning) be authorized by the EAIYA depending on their dossier. The majority of the CoE held (154/15) legal setting, if adding a provision that would oblige them to ensure a "detailed and reasoned judgment EAIYA" the sufficiency of these laboratories to ensure proper operation under the rules of medical science. In contrast, the minority held that no exemption is justified by the new standards.

PD plan provides for the establishment and MIYA operation in the form of public entities, private entities and individuals who have medical license to practice, with the possibility of origin from non-EU countries. At the same time determines the minimum staffing MIYA, qualifications and skills of employees (doctors , laboratory - nurses), prohibiting work in criminal or disciplinary convicted on offenses and imposing additional staff (150 IVF cycles) to avoid any errors due to fatigue. On private MIYA must interface with hospital or clinic (with obstetrics department) at a distance to 15 km. To address any complications.

Two years of experience

Among others require at least 2 years experience in the field of in vitro by obstetricians gynecologists, scientists, biomedical sciences, anesthetists, midwives. Also identified in detail the qualifications of the scientific responsible of MIYA of embryology laboratories, the requirements of premises and equipment, quality standards and control procedures.

Anticipated even through special software to link the files MIYA registers of EAIYA for traceability of biological material and prevent potential adverse events.

Set the status of regular - extraordinary checks on MIYA, with a "freeze" or revoke an operating license if violated terms and specifications.

Alexandros Avlonitis

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