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Address of the Minister of Health of the Republic of Slovenia, Zofija Mazej Kukovič, at the Networking Meeting of the Competent Authorities for Pricing and Reimbursement of Medicinal Products

Respected Heads and Experts of the Competent Authorities of Member States,

Respected Director General and Representatives of the European Commission

Respected Members of the Pharmaceutical Forum Steering Committee

Respected Invited Lecturers and Moderators;

Respected Participants of the Meeting

It is my great pleasure to have the opportunity to address your meeting. It is also my delight to greet you in Slovenia in the spring while we are about to enter the last third of our Presidency term. As the first among the new Member States which joined the European Union on 1st May, 2004, to hold the Presidency, we take it as a great honor for Slovenia and we have been trying to fulfill it with all the necessary responsibility. Today, I would like to express my support for your efforts to increase your mutual cooperation. 

In the area of pricing and reimbursement we are convinced that an increasing need exists at the EU level for a more intensive cooperation among the Competent Authorities of the Member States with the participation of the Commission. Our aim is to complement results of the Pharmaceutical Forum in the field of pricing and reimbursement and to contribute to the long-term cooperation among these authorities for the benefit of EU citizens. Gradually, the network could develop relations with other stakeholders; some of them have clearly indicated their interest. But before I say more on today's topic, let me share with you some more general aspects of Slovenian EU Presidency.

The priorities of the Slovenian Presidency were to a large extent determined in the context of the 18-month programme of the German, Portuguese and Slovenian Presidencies. As the final part of the three consecutive presidencies it is our responsibility to complement and complete the excellent work started by our German and Portuguese colleagues. I am happy to see that also the events in the area of pharmaceuticals are linked. I refer here mainly to the two successful conferences on pharma innovation organized by the two preceding presidencies.  New technologies stemming out of the innovation process are already knocking on our doors and are likely to become a key issue in the network we talk about today.

The motto of Slovenian Presidency is synergy for Europe. Given the important tasks ahead of us – the Union will only be successful if working together. We will therefore strive for more synergy between Member States, EU institutions, people, synergy in relation to international community, between generations and cultures. Synergy means a basis of our coexistence, our common work and our value added. In a particular way. By networking in your field, you can contribute substantially to this paradigm, as pharmaceuticals an important part of health care as well as research and industrial development and innovation.

In this context, Slovenian Presidency would also like to promote the exchange of best practices. One of the advantages of the European Union is that each Member State and European Institutions has developed policies and practices which could serve as a role model also to others. This is one of our strong potentials, which we all have to be aware of and exploit better within the Union. In your concrete area of work, this is also as one of the principal goals of the Pharmaceutical forum.  It has in the meantime entered its final phase of activities which for us means that some form of continuation of its activities and consideration of its deliveravles is needed.

Five main priority areas of Slovenian Presidency are the future of the Union and the timely ratification and implementation of the Lisbon Treaty, successful launching of the new Lisbon Strategy cycle, a step forward in addressing climate-energy issues, strengthening of the European perspective of the Western Balkans, and promotion of intercultural dialogue in the context of the European Year of Intercultural Dialogue.

Among the Slovenian Presidency initiatives in the health field, the central topic that has raised a lot of support across each and every EU Member State is how to reduce the burden of cancer. In order to successfully tackle the cancer burden, we will need a comprehensive and integrated approach at all levels, from disease prevention, organised screening and early detection to optimal treatment, rehabilitation and palliative care, combined with investment in research in all these areas. As oncology represents one of the major areas of advent of new biologic medicines, it represents a challenge for pricing and reimbursement decision making. A dialogue with and the active involvement of civil society, nongovernmental organisations and groups representing patient interests in activities for control of the problem are an important element of success. The Presidency plans to prepare Council conclusions and submit them to the Council for adoption at its meeting in June 2008.

Other health programmes include antimicrobial resistance, reducing alcohol related harm, nutrition, overweight and obesity issues, mental health and e-health, but today I intend to focus more on pharmaceuticals. On a national platform, Slovenia has developed a Resolution on National Health Programme which puts strong emphasis, on the area of pharmaceuticals. In this document, we have set the goal that the population should have access to innovative and cost-effective medicines. Slovenia is, in its position of a small national market and a medium per-capita GDP Member State on EU level, vitally interested in international cooperation in the area of value assessment of medicines. We have been one of the countries that strongly welcomed recent initiatives leading to today's event.

We are organizing, together with the European Commission, this meeting of competent authorities of EU Member States on pricing and reimbursement of pharmaceuticals. Our aim is to invite you all to address the modalities of establishing a voluntary functional network for the exchange of experience in the application of tools and practices. These have been under discussion in the Pharmaceutical Forum as well as in some other initiatives with EU relevance. We understand that national competences of Member States and their pricing and reimbursement policies need to be taken into account. At the same time we believe that the need for common understanding of principles, development and consideration of best practices, and consolidation of activities exists among the Member States. We expect this meeting will acknowledge the deliverables of the Pharmaceutical Forum and other initiatives in terms of the current developments in Member States and that it will provide for the kick-off of the network. We definitely see the network as a long-term multi-presidency project and welcome the positive reflections of the upcoming presidencies, who are showing willingness to continue the networking activities.

Medicines should be viewed in a broader perspective of the EU agenda and I would like to say few words on information to patients as well. Better informed patient is likely to require more information on the value aspects of medicines as well, therefore networking efforts in the area of pricing and reimbursement are justified also from this angle. The Communication from the Commission concerning the Report on current practice with regard to provisions of information to patients on medicinal products has been presented in December.  Patients are today more proactive users of healthcare, increasingly seeking information, particularly through internet and being more involved in making decisions regarding their treatment. Patients should be informed, but the difference between advertising and information should be clear. Advertising for medicines on prescription is banned in the existing EU legislation, but the level and type of information that can be made or is available to public, particularly through Internet differs in Member States, so EU citizens have unequal access to information; 

The Slovenian Presidency is giving the deserved attention to this Communication in the Council and intends to present conclusions on the subject, with an aim to contribute to the quality of the amendments to the current legislative provisions on the provision of information to patients that the Commission intends to present by the end of 2008.

We expect that the work on the proposal for amending the legal basis of “Variations Regulations” will be initiated during our Presidency. With these amendments all authorised medicinal products would be subject to the same rules for the approval and administrative handling of changes, regardless of the procedure under which those medicines have been authorised. We intend to have a presentation of the proposal in the Council and first exchange of views.

In returning to today's topics, we believe that advances are needed in the development of tools for the scientifically based and transparent assessment of the value of new and existing medicines.  Slovenia has, like numerous other Member States, introduced a system of reference prices of medicinal products, five years ago. The system represents a principal tool for moderating the growth of public and private expenditures for medicinal products. At the same time it is a mechanism that establishes immediate and long-term systemic conditions for price competition and lowering, and rational use of medicines. Currently, the system is entering its 10th phase, and is in stable operation and is yielding expected results in annual savings of approx. 5-10% of the total market value. National market is worth approx. 500 MIO € (spending of approx. 250 € per capita), of which the value ratio between the innovative medicines and generics is approximately 35/65.

We understand that the assessment of relative efficacy and relative effectiveness is an important prerequisite for rational and transparent decision making. Although we understand, that these activities are performed in other complementary networks, it is vital to assure good cooperation and we are interested to share experience. We, for instance, can share experience how we have contemplated the concept of mutually comparable medicines. This additional system would enable systemic comparison of selected therapeutic groups of medicines with the aim to enable consequent comparison of their added therapeutic value and relative efficacy. Based on the assessment, pharmacoeconomic model including the concept of cost effectiveness would be added, and in each therapeutic group of medicines, reference products would be selected with the best added therapeutic value and cost effectiveness. The concept was recently subject to intensive debate and was eventually deleted from the draft of the Law.  However, it is likely that it will be further examined as a potential access to innovation and cost containment balancing mechanism and perhaps included in the legislation in the future. Here, the current activities at the EU level, mainly those of the Pharmaceutical Forum were expected by us to yield some new mechanisms of attribution of value for medicines. We hope that perhaps the upcoming presidencies may tackle the issue and develop it further.

In addition to all this, we believe that development of policies on high-tech-high-cost biological medicines is urgently needed throughout Europe. Political, professional and public awareness has been raised for the implications of the advent of new high-tech-high-cost medicines which bring new possibilities of effective and safe treatment of some serious diseases. At the same time, these treatments bring new substantial burden to the public funds. Mechanisms of the inclusion of these medicines in the national health plans have been developed at the level of the Ministry of Health, Health Council, National Health Insurance Institution and terciary clinical institutions. Abovementioned cost-saving mechanisms of generic substitution and mutual comparability of medicines will, along with other necessary cost-containment mechanisms, serve as means to provide headroom for the coverage of the costs of uptake of new biologic medicines. A scientifically justified and socio-ethically sound redistribution of funds will be necessary among the several types of treatment and classes of medicines to accommodate the fast growing cost. Once again, Pharmaceutical Forum has been expected to  provide some  EU-level orientation for this problem by enhanced data and scientific expertise exchange thus better serving the member states in reaching their pricing, reimbursement and relative efficacy decisions within  their national competence.

Slovenian prescription market consists of approx. 4000 medicines with 1000 chemical entities, of which one half benefit from at least partial reimbursement from public funds. This high level of public health protection should not be jeopardized by the well recognized cost drivers such as aging population and the advent of high cost new medicines.

Last but not least, I would like to raise your attention to my personal concern. Better Regulation policy agenda in the field of pharmaceuticals should also address the existing problem of availability of medicines that has a negative impact on public health. The problem of unavailability of medicines exists particularly in Member States with small markets even if all possibilities given by the existing legal framework are optimally used. The problem has a strong ethical economical and regulatory dimension. It is a problem for economically unattractive markets, while patients' rights to get the medicine remain the same. This sensitive issue should be carefully considered in the near future. I would also like to ask to take this concern into account in the build up and functioning of the network.

With this, respected participants, I wish you a successful meeting and efficient networking in the years to come, and a pleasant stay in Slovenia.


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Date: 28.04.2008