S.L. 524.2 ст. 32

Fees to be paid to the Embryo Protection Authority (EPA) by all Service Providers of Tissue establishments/clinics both Public and Private

User Guide to the Protocol

What is the purpose of the Protocol?

The Embryo Protection Act (the Act) covers the use and storage of sperm, eggs and embryos for human application. One of the ways we help licensed tissue establishments (Tissue Establishments) comply with the Acts by publishing the Protocol. We have a duty under the Act to maintain a protocol that gives guidance about licensed activities and the people who carry them out.

This Protocol also serves as a useful reference for patients, researchers and those working in the fertility sector.

How is the Protocol structured?

The Protocol consists of:

Regulatory principles for licensed tissue establishments whether private or public, and

Guidance notes

This Protocol has been prepared in line with EU Directives, National Legislations, HFEA Code of Practice as well as the BICA Practical Manual.

Regulatory Principles for Licensed Tissue Establishments

The Act requires the Embryo Protection Authority (EPA) to maintain a statement of the general principles that we consider should be followed in carrying out activities covered by the Act.

The principles:

A summary of the key behaviours and outcomes the EPA expects each licensed tissue establishment to demonstrate, and

A means of communicating to the responsible person and staff at each licensed tissue establishment, patients, and the public the areas of compliance that the EPA regards as key.

Compliance and enforcement

The EPA has a duty to promote compliance with:

The Act, and

The Protocol.

Regulatory principles will inform the inspection process. If the EPA becomes aware that a tissue establishment has not complied with the legislation or the Protocol, we may take action in line with provisions in the Act.

Regularity Principles

The EPA expects the responsible person to ensure that their licensed tissue establishment demonstrates adherence to the following principles when carrying out activities licensed under the Embryo Protection Act.

Licensed tissue establishments must: