Erkki Liikanen: "Challenges to combat neglected diseases", Round Table on lack of R&D for neglected diseases Brussels, 19 September 2002

Brussels, 19 September 2002

Ladies and Gentlemen,

Neglected diseases are an issue of utmost importance. More than 14 million people are dying each year from infections and parasitic diseases in the developing world. Dying although most of the diseases are preventable or could be treatable.

Obviously this situation has to change. The world needs new avenues to tackle this issue in order to bring effective help to those affected.

I am very grateful to you, Ms Corbey, for organising this Round Table and for bringing together experts and politicians. Indeed, this is a good opportunity to gather ideas about new ways forward.

To tackle this issue, we need of course a coordinated response at international level. The European Union and its Member States should play here a leading role.

A coordinated approach means also that all parts of the public sector have to contribute. Neglected diseases occur in the developing countries; their treatment necessitates improved R&D as well as better health care provisions. It is indispensable, therefore, that these efforts are integrated into the EU's Development policy, into its Research policy and also into its Health related policies, including pharmaceutical questions.

But a coordinated approach encompasses also efforts by the private sector, including in particular the pharmaceutical industry.

Backed by an appropriate regulatory framework, the pharmaceutical industry can indeed bring an irreplaceable contribution to the development of medicines the third world needs.

I am aware that important organisations like Médecins sans frontières have been rather critical towards the role the pharmaceutical industry is willing to play in this area. They fear that, since patients in the developing countries are too poor to buy medicines, significant progress could not be expected by profit-oriented industry.

No doubt: successful progress in defeating neglected diseases cannot be expected from the pharmaceutical industry alone . States and international organisations should accept to fulfil their own responsibilities. And, surely they have to do so more than they did in the past.

However I believe a coordinated approach based on both private and public endeavours towards the same goal is, in this context, badly needed for two reasons:

First, we need the industry capacities to ensure that innovation is adequately transformed into innovative medicinal products.

Advances in science and medicine can contribute to providing significant cures to neglected diseases. Such advances can be achieved by private or public research. I appreciate that private research is increasingly supplemented by research of university and government facilities where indeed public spending and political impetus are essential.

However, research as such is not enough. Before people can actually benefit from this research, it needs to be developed into a final medicinal product which can be produced at a very large scale. These steps are currently almost only undertaken by the pharmaceutical industry; even in case of successful public research.

And it is very unlikely that, in the near future, any public facilities will have the means to take over this role to any significant extent.

There is a second important reason: the valuable experience with so-called public-private partnerships in the recent past, partnerships encompassing then the complete development of medicines from basic research to final manufacturing, not to mention packaging.

The public and private sectors have already been co-operating in various projects on solutions for neglected diseases for a couple of years. Let me give you just two examples: The "Global Alliance for Tuberculosis Drug Development" works on new medicines for tuberculosis. Similarly, the "Medicines for Malaria Venture" undertakes research on new medicines for malaria.

Clearly, it is too early to evaluate the success of these approaches. But I believe they are promising, encouraging examples which are showing that public and private sector can indeed work together to bring new solutions, new therapies in the fight against neglected diseases.

As regards "public" responsibilities and to give you an idea on how regulatory initiatives contribute in concrete terms, let me mention two recent Community projects developed under my responsibility. Interestingly, these projects respond to two different categories of diseases: those where it exists at least some pharmaceutical market in the EU and those where this is not the case.

The first is the new legislation on orphan medicinal products.

For the industry, a lack of commercial interest is the key problem in the context of neglected diseases. For certain serious, but rare, diseases in the EU we have a very similar problem. Too few persons are affected by the disease to attract sufficient private research for ensuring innovative and effective medicines.

In response, the EU adopted in 2000 a new legislation on these so-called orphan medicinal products. Because there is very little commercial interest of pharmaceutical industry in these therapeutic areas, we have had to add further regulatory incentives to trigger R&D, mainly through the granting of a marketing monopoly.

This kind of mechanism works. We have an increasing number of applications for orphan medicinal products since the new regulation entered into force. We believe that this legislation could support the development of medicines for certain neglected diseases!

True, its focus is diseases within the EU. But the new incentives apply wherever the disease treated is rare in the EU. If not more than 5 in 10.000 people are affected in the EU, then a product can benefit from the incentives, even if the disease is very widespread outside the EU.

This could trigger significant R&D for example on diseases, which do not generally exist in Europe. It is true however that this legislation will have few effects on the level of production required to cover the needs of the developing world!

So far, no medicinal product for a neglected disease was granted the orphan status in the EU. But experience with similar orphan legislation in the US shows that around 10% of products with orphan status in the US relate to these kind of diseases.

The second initiative I would like to mention is to be found in the current review of the pharmaceutical legislation:

Many diseases do not exist in Europe at all. There is no corresponding pharmaceutical market in the EU. Some other diseases are now benefiting from new treatments adapted to our society while they would require other type of medication in the developing world. Moreover, many developing countries have too few scientific experts to evaluate and check the medicinal product they need. These countries and WHO rely more and more on our expertise to perform these evaluations before the products are marketed on their home countries.

That's why we proposed, in the Review, a new mechanism specifically designed for those products needed only by the developing world.

We proposed that the European Medicines Agency in London should have the possibility to evaluate a medicinal product, according to the same EU standards, even if it is to be marketed exclusively outside the EU.

In order to ensure an efficient cooperation with the organisations, and countries acting in the field of medicines availability in the developing world, the EMEA shall proceed with such assessment only on products designated by WHO.

This proposal, worked out in collaboration with WHO, has so far found broad support by the European Parliament and by the Council.

To sum up:

• I believe the fight against neglected diseases requires indeed a coordinated approach, involving the public and private sector.

• Even if further public responsibility is needed, in particular in the sectors of development and research policy, we should more and more find means to get the pharmaceutical industry involved in clear and targeted projects.

• Public pharmaceutical policy can contribute to the overall efforts. In the EU, we have already taken steps in this.

• And I believe it's worth continuing on this path !

  DN: SPEECH/02/410 Date: 19/09/2002

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