Mr. Guðlaugur Þór Þórðarson
Minister of Health – Iceland

INTERNATIONAL CONFERENCE

“COMPETITION AND PHARMACEUTICAL POLICY IN EUROPEAN LAW

THE CHALLENGES FOR SMALL EUROPEAN MARKETS“

Organized by

UNIVERSITYOF ICELAND- FACULTY OF LAW - MINISTRY OF HEALTH

12 SEPTEMBER 2008

Conference Room of the National Museum of Iceland

„A new public pharmaceutical policy for Iceland: future challenges in the framework of the European Economic Area and the Nordic Area“

Dear conference guests, ladies and gentlemen,

I welcome you all here today.

In particular I want to welcome foreign guests and speakers for visiting our country in order to participate in the conference. I hope during your stay you will also have opportunity to do something else and see something else here in Iceland than this conference hall.

It is a great pleasure for me to address this international conference on competition and pharmaceutical policy in European law with special focus on challenges for small European markets.

I want to thank the University of Iceland, the Faculty of law, for taking the initiative and for organizing this conference in cooperation with the ministry. I also want to use this opportunity to congratulate the Faculty on its 100 years anniversary which I understand is the main reason for this initiative.

I am quite pleased that challenges facing the small pharmaceutical markets of Europe have been chosen as a topic for the conference. During my first year as Health Minister I have particularly been interested in this topic and in pharmaceutical policy in general and I am therefore pleased that this conference has been realized.

But why should we be interested in organizing a conference on this topic?

Like other small countries in Europe, Iceland is facing some difficulties in the pharmaceutical field. These difficulties are related to high price of medicines, lack of availability of generics and low volume medicines and lack of competition on the market.

The use and cost of medicines in Iceland is high compared to other European countries but in spite of high price level we have also experienced lack of some essential medicines on the market.

Some medicinal products are not always made available in small countries like Iceland. It doesn’t seem to be profitable for the industry to apply for market authorization in small markets, especially when it comes to products of low volume, low price and specialized products intended to treat severe or rare diseases.

Access to medicines is one of the corner stone of the Icelandic Medicine Policy and in my opinion the choice of whether products are placed on the market of individual Member States should not be solely a matter of business viability, public health needs should also be considered.

We are also facing certain language problem as the translation cost is relatively higher for smaller markets like Iceland. The pharmaceutical industry has complained about this during discussion on how to approach common principles on pricing.

We have been pushing for a pragmatic solution of this problem, which is to permit pharmacies to print out leaflets in Icelandic text which are available at our Medicine Agencies website.

We are aware of our obligations to the EEA treaty and we have in Iceland been trying to apply all directives of the European Union in a very strict manner. These directives may fit nicely to bigger markets of Europe but the problem is however that they do not fit as well to smaller markets.

I can say this more clearly with other words: The EEC legislators have failed to consider the interest of smaller markets. The market is not working for pharmaceuticals like for other products in the European Economic Area. There is no free flow of medicines in Europe.

Obviously we need more pragmatic solutions and rules for market mechanism on small markets to work in order to make essential medicines available and affordable for our patients and health institutions.

One of my first tasks when I became Health Minister was to meet two commissars of the European Union in Brussels, Mr. Verhaugen and Mr. Kyprino and discuss with them these specific and common issues for small markets.

I got very positive response from the two commissars and they told me that they would establish a working group under the Pharmaceutical Forum with the task to address the unavailability of many medicines to small markets. Iceland was invited to participate in this working group together with Cyprus, Estonia, Malta and Slovenia. I assume that the results and recommendations of the working group that were put forward to the Pharmaceutical Forum this summer will be taken up and discussed here today at the conference.

As an input for the discussion I want to mention our cooperation with the Nordic countries concerning these issues. At the Nordic Council meeting in Oslo on the 1^st of November last year I put forward for discussion among my colleagues my ideas concerning common Nordic market for medicinal products and other health services.

One of my ideas was to encourage the Nordic Council to establish an expert committee with representatives from all the Nordic countries with the task to investigate the possibility of closer Nordic cooperation concerning marketing authorizations of medicinal products with the purpose to overcome technical barriers to trade with medicines between the countries and open up the pharmaceutical market.

The Nordic Council accepted this proposal and put up an expert committee with the task to investigate the possibility of a common Nordic market for medicinal products.

Through this Nordic cooperation we have already started a pilot project on co-operation between Iceland and Sweden concerning marketing authorization of medicinal products, in particular those marketed by Mutual Recognition and Decentralized Procedures.

With full respect to national competences, through this cooperation an approved request for authorization in Sweden, will automatically lead to authorization in Iceland if the manufacturer agrees to let the application also apply to Iceland. It is clear to me that such cooperation reduces administrative processes and related costs for the companies, while ensuring access to safe and qualitative medicines.

It is our belief that this is the way to go and we would very much like to see more countries join this cooperation in the future. We hope this cooperation will lead to common marketing authorizations, to a more flexible and open pharmaceutical market for all the Nordic countries at first and later on for other European countries.

I will also use this opportunity to mention another cooperation we have started with Sweden concerning pricing and reimbursement of medicines and our cooperation with the Faeroe Islands in the field of health services and in particular pharmaceuticals.

On Tuesday this week we organized the first meeting of Nordic cooperation on tendering and purchasing of medicinal products for public health institutions.

So far so good, but where do we go from here?

I am very pleased that we have a speaker from Malta with us here today. I believe that Malta and some other small countries of Europe have had the same experience as we in Iceland with lack of competition, lack of some essential medicines on the market and too high pricelevel compared to bigger markets.

I hope and believe that small countries with this experience will manage to cooperate and together open the eyes of the legislators in Brussels so that special interests of small markets will be taken into account.

Our purpose with the cooperation we have worked for and in fact also the purpose with this conference is to try to get common understanding for the need of a more open and flexible pharmaceutical market with more competition, better access and lower price of medicines to the benefit of our patients.

I hope your work will be successful here today.

(Talað orð gildir)