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Cryos International Aps

Cryos

Vision: To help childless make their dream come true. Mission: To provide high quality human sperm and eggs from selected and screened donors of all ethnicities and phenotypes. Values: Our values express our beliefs and culture. They outline the foundation for how we work in order to achieve our vision and mission. Furthermore, they define how we operate in relation to our customers, donors, and other interest groups, such as legislators and journalists. Help & Care is to... make our services easily accessible help our donors and customers through the decision process       care about our donors’ and customers’ needs and wishes Safety & Professionalism is to... ensure high standards of quality and safety have an honest and thorough business approach focus on documented and traceable procedures Innovation & Development is to... allocate resources for innovation and research seek new challenges with an open mind cooperate and network internationally (...)

Lobbying Activity

Response to Revision of the Union legislation on blood, tissues and cells

8 Sept 2022

Cryos International Sperm & Egg Bank agrees on the identified shortcomings and inadequacies in the current European Tissues and Cells Directive and implementing Directives and welcomes update of the current legislation to allow for more flexible alignment to scientific and technological developments. Cryos appreciates that policy option 2 is chosen to solve the current challenges. This policy ensures the possibility of rapid updating of safety and quality requirements defined by European Expert Bodies. Cryos finds the submitted proposal for a Regulation positive and appreciates being heard and involved in the process. We take this opportunity to express our views on some identified shortcomings in the current proposal and to put forward recommendations for consideration in the further revision process. Please see the attached position-paper for specific comments and recommendations. GENERAL REMARKS: Optimize access to SoHOs intended for human application The overall objective of the update of the legislation is to ensure a high level of health protection for EU citizens. This goal is not only achieved by enforcement of safety and quality requirements, but also by securing an optimized access to secure and safe SoHOs for everybody, especially within medically assisted reproduction. Cryos believes that much greater focus should be placed on the security of supply of SoHOs for medically assisted reproduction for clinical- or self-treatment, both in cases where the substance is imported from countries outside the EU, and in cases where the substance is exchanged between EU Member States. The Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law. Cryos believes that this results in preventing all patients from actual access to safe treatment with SoHOs. This problem is already well known today, where Member States restrict some people from access to SoHOs and medically assisted reproduction only because of their sexual orientation, cohabitation etc. Cryos therefore believes that the proposal should define a right for everyone, regardless of gender, cohabitation, sexuality etc. having access to and treatment with SoHOs. Donor Registry The demand for medically assisted reproduction is increasing, and it is expected that the increase will continue in the future. Therefore, it is necessary to ensure that all patients who need medically assisted reproduction treatment have access to safe donor eggs and safe donor sperm/ SoHOs. Cryos suggests ensuring further protection of donor conceived children and women in fertility treatment by establishing a common Donor Register in EU. A common EU register for sperm and egg donors, wherein all donors are given a unique ID donor number, will establish a much better insurance that donors do not donate their gametes in several different places or countries. A common register will make it easier to ensure traceability if knowledge of a hereditary disease from a donor or a donor child is obtained. In addition, this will mean that a donor child always has access to personally identifiable information about a donor who has consented hereto, in cases where a SoHO entity/SoHO establishment is no longer active. Accordingly, a common register could help increase patient safety in the EU as well as data security and accuracy in SoHO entity/SoHO establishments. With a high level of patient safety and several highly specialized and experienced SoHO organizations, an EU Donor register can advantageously be placed in and administrated from Denmark.
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