It is my pleasure to share with you a good news that during the plenary session in May the Directive on Standards of Quality and Safety of Human Organs Intended for Transplantation was adopted in teh European Parliament with an overwhelming majority. I believe our effort will bring its results and improve quality of life of thousands of patients all over the European Union.

As we could have witnessed over past five decades, organ transplantation has been transformed from an extraordinary exercise in immunobiology to the most practical way of rehabilitating patients with the illnesses resulting in fatal kidney, liver, heart, lung and pancreas diseases. It has become an established and efficient worldwide practice which tremendously improves quality and extends the life expectancy of our patients. Nowadays, we need to pay significant attention to the reality, that in the countries of the European Union, there are more than 60 000 people on waiting lists to receive a functioning organ. But what is even more alarming in this context, is the fact that the number of patients on the waiting lists increases much faster than the number of organs available for transplantation. Shortage of organs is therefore a major factor affecting transplantation programmes. However, we can not also forget and ignore that scarcity of organs and imbalance between need and availability might lead to cases of commercialization and illegal organ trafficking.

Meanwhile shortage of organs remains the most important challenge, there are many more with regard to the different transplantation systems applied in Member States. Therefore, the new Directive seeks to enhance cooperation and cross border exchange between Member States, which has an impressive potential to increase number of transplantations. In order to ensure high level of health protection throughout the European Union, the Directive effectively establishes common binding standards of quality and safety of human organs intended for transplantation. It entirely completes the framework of legislation on human blood, tissues, cells and organs. As a medical doctor, I appreciate very much the text which has achieved a broad support. In particular, I highly welcome the principal and key aims of the Directive.

First of all, the objective to ensure the quality and safety for patients at the EU level, secondly, ensuring the protection of donors and, last but not least, facilitating the cooperation between Member States. In general, in the European Union there is broad societal consensus on organ donation for the purpose of transplantation. However, due to different cultural, traditional or organizational system background, there are still differences between Member States in approach to this issue.

As a matter of principle, organ transplantation programmes are based on the principle of voluntary and unpaid donation. I am fully supporting the principal that organ donation must always be a free gift and protected from any linkage to possible commercialization. I am glad we successfully defended this very principle. Moreover, I consider the organ donation as a gift and supports expression of altruism and solidarity in the society. Traceability of organs from the donor to the recipient and vice versa represents one of the major safety concerns, therefore sound data protection measures of donor and recipient must be introduced.

Although, large differences in organ donation and transplantation shows that some organisational models perform better than the others. Sharing of the best practices, models and expertise across the European Union has already proved as being useful in increasing organ donor rates. Therefore, in my opinion, the cooperation should be fostered in order to identify successful elements of different transplantation systems and promote them on the European level, thus leading to the improvements in provision of high quality and safety of organ donation and transplantation.

Miroslav Mikolasik, MEP

This represents the opinions of Mr Mikolasik and not necessarily those of Health First Europe.