‘Member states want to block any change on pharmaceuticals’

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The first meeting of the High Level Pharmaceutical Forum (HLPF) is set to be difficult. In order to control the health costs, the member states are likely to block any change on the topics under discussion: pricing of medicines, the assessment of relative effectiveness of drugs and information for patients, argues MEP Jorgo Chatzimarkakis in an interview with EURACTIV.

The High Level Pharmaceutical Forum (HLPF) was set up in 2006 to follow-up on a number of issues identified by the G10 Medicines Group. It provides a high-level platform for discussion on the effects of pharmaceutical innovation on national health systems in Europe. Three working groups have held meetings since early 2006 on: pricing and reimbursement of drugs, information to patients on new drugs and the cost and clinical effectiveness of medicines.

The forum is jointly chaired by Health Commissioner Markos Kyprianou and Industry Commissioner Günter Verheugen. Participants include the health ministers of the EU-25, three members of the European Parliament and ten industry and other stakeholder representatives. 

The first meeting of all three working groups will take place on 29 September 2006. 

What is the mandate High Level Pharmaceutical Forum (HLPF) ? 

The mandate of the forum is threefold and that is why it has three working groups. The first working group is looking at the European pricing policy in the pharmaceutical sector, because the prices differ from country to country. The question is whether the current state-controlled pricing-system is still up-todate. 

The second issue is the efficiency of medical products. That is to say the EU and especially the member states are trying to assess the efficiency and innovation in the pharmaceutical sector and evaluate how much innovation should cost. For example, a company discovering a new life-prolonging drug for a serious disease wants the price for this drug to be, for example, 15% higher. However, the state, which is controlling the prices, can judge that the innovation allows only for a 5% increase. To evaluate the relative effectiveness of medical products, and to assess their price, member states have set up special agencies, such as NICE in the UK and IQWIG in Germany. 

But how can we objectively know the cost of innovation?

Cost of innovation depends on its definition, and this is a problem in the EU, as member states have different views on the issue. Having 25 different definitions of cost-effectiveness (or none, especially in the new member states) on the single market is one of the major problems. Companies wanting to produce medicine in the EU have this big bureaucratic burden of 25 systems. It is not a single market. We should compare the effectiveness of these bodies in different countries and choose the best. This is what the working group of relative effectiveness is working on. Perhaps we could have a common European body for this purpose. The European Medicines Agency (EMEA) can not really take the job, unless its drastically cut budget is reviewed. We could also think of the national bodies specialising in different drugs. For example, NICE in the UK would concentrate on assessing the cost-effectiveness of drugs for cardiovascular diseases, whereas the IQWIG would specialise on new diabetes drugs. In this case, the EMEA would then only be co-ordinating the game. 

The third working group discusses information to patients, which is perhaps the most sensible point. We currently have an advertisement ban but also an information ban: it is not possible to inform directly the patient on the medicine prescribed to him by the doctor, unless this person gets the information on the internet. There are several problems linked to this. I can understand a ban on advertisements but I can not agree on the ban on information, which leads us to a situation where patients are obliged to surf the internet. The problem here is the lack of systems with reliable information about medicine in one’s respective language and the patients are left to on their doctor for information. 

The whole problem in this high-level pharma forum is the member states. The member states want to block any change in assessment of relative effectiveness of medicines as they want to keep the costs down. They try to avoid any change in pricing because they want to control the costs. And, thirdly, they want to control the information. I really can not agree with the last point – you can not be cut out of information by your own government on issues so important as your health. 

So, to put it bluntly, member states do not want to give information to patients on drugs that are perhaps more efficient, but that cost more, and this way ensure that patients will not ask for them, so that public health costs can be better controlled? 

Yes.

The pharmaceutical forum was created to tackle issues hampering pharma-innovation in Europe. Do you find that the issues tackled in the forum are the right ones and that 
the forum will solve the innovation problem? 

Yes, of course. Before the World War II, Europe was the pharmacy of the world. Most of the new drugs, innovation in the pharmaceutical sector and in general on the health sector came from Europe. This has changed. The US is now more innovative and effective in this respect and Asian countries are building up a lot of knowledge. This means that we have to reconsider how we over-bureaucratise our companies and dissuade them from coming and doing their research here. If you do research, you need income as well. You can only have income if there’s an attractive single market. Health will create wealth, the health market will create wealth if you lift all the barriers of trade within the single market. 

The pharmaceutical market in general is not really a market, it is a planification – worse than in Comecon. In no other market, even agriculture, do states decide prices, as they do for the pharmaceutical industry. This is something we need to reconsider, as with these conditions we can not expect competitiveness in the European pharmaceutical industry. The questions tackled in the pharma forum are expected to give new impetus to the sector. 

For comparison, in the US, new medicines have higher prices, but with ‘blockbuster drugs‘ (that are no longer under patent-protection) prices go down radically. In the EU, new medicines are forced on to the market at low prices but blockbusters have high prices – which is totally illogical. The system does not work, the companies and industry are leaving Europe because of these market barriers. 

What outcomes are expected from the first meeting on 29 September 2006 and when will the forum finish? 

The forum will hold its first exchange of views on all three issues in order to understand where we are and what the member states, Parliament, the Commission and stakeholders think. 

The forum will try to finish its work by 2008. It is expected to propose new legislation on relative effectiveness, pricing and information ban. 

***

MEP Jorgo Chatzimarkakis is a member of the Parliament’s Patient Information Network (PIN) which is set to send, before the first meeting of the High Level Pharmaceutical Forum on 29 September 2006, an open letter to Commissioners Kyprianou and Verheugen on the issue of patient information. The PIN believes that legislative change is needed at the EU level to ensure free and equal access to medicinal information for all European citizens. In their letter, the MEPs will call for the removal of the current patient information ban in Directive 2001/83/EC on the Community code relating to medicinal products for human use.

Chatzimarkakis has also recently launched the European life science circle, “to give chance to those, not members of the pharmaceutical forum, to pre-discuss and pre-assess views on the three topics of the forum”. The circle is open for other MEPs, their assistants, pharmaceutical lobbyists and journalists.

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