EN Official Journal of the European Union CE 84/777

(2004/C 84 E/0874)

WRITTEN QUESTION E-0347/04

by Glenys Kinnock (PSE) to the Commission

(11 February 2004)

Subject: Use of ACT in treatment of malaria

Would the Commission outline its position on the use of ACT (artemisinine combination) for the treatment of malaria?

Is the Commission aware that whilst ACT is the treatment recommended by the World Health Organisation, there is a reluctance to introduce ACT combinations in countries with high resistance to other drugs because of the costs involved?

How does the Commission propose to deal with this growing problem?

Answer given by Mr Nielson on behalf of the Commission

(18 March 2004)

The Commission is aware of the expansion of malaria strains resistant to anti-malarials, particularly chloroquine and sulfadoxine-pirimethamine (SP). The World Health Organisation (WHO) issued malaria treatment guidelines in January 2003 and November 2003 where they recommend five therapeutic options, of which four are artemisine-combination therapies (ACT), for regions with low levels of resistance to these drugs, such as West Africa. While the recommendations rely on epidemiological, parasitological and clinical criteria, there is no in-depth analysis of the costs involved and the capacities of countries and the current international financial instruments to ensure a sustainable strategy. The specific role of ACTs in all treatment levels, including frontline treatment, or referral levels, is not detailed either.

Malaria treatment strategies in countries are decisions that must be taken by each country after weighing up the potential impact, the investments needed, their resources and capacities and the comparison with other alternatives. Some countries outside West Africa, such as Mozambique, have decided on non-ACTs strategies.

Within the framework policy of the ‘Programme for Action: Accelerated action on human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), malaria and tuberculosis in the context of poverty reduction’ (1), the Commission aims at reducing the burden of malaria though the three main pillars of the programme, all related to malaria treatment.

The Commission is trying to increase the impact of interventions. To this end, the Commission has speeded up and increased the support to malaria programmes. Overall, the Commission has programmed EUR 1,1 billion to fight these diseases in the period 2003-2006, some 25 % of the interventions targeting malaria. This includes the Commission contribution to the Global Fund (EUR 460 million for 2001-2006), where USD 30 millions have already been committed for the purchase of ACTs in the three first proposal rounds. The Commission has also programmed support under the thematic budget line on poverty diseases, to initiatives introducing malaria combination therapies, including ACTs. But the bulk of the Commission support for countries to progress towards health-related Millennium Development Goals (MDGs) — including the 6th MDG related to malaria is through sector and, progressively, general budget support. The capacity of any country to decide on the inclusion of the most effective treatment options will be related to their financial capacities and it is here where the Commission tries to direct the lion's share of its support.

The Commission continues to be active in promoting the reduction of prices of essential medicines such as ACTs, through advocacy and legal support (such as the regulation to prevent re-importation of tiered-priced medicines) of tiered pricing, the use of Trade Related Intellectual Property Rights (TRIPS) provisions and the promotion of local production of ACTs. In this regard, the Commission is in the process of reviewing initiatives aiming at local production of quality and affordable ACTs, submitted following a call for proposals launched in 2003.

The Commission has also programmed significant research resources to develop more effective medicines and vaccines for HIV/AIDS, malaria and tuberculosis. This includes support, in partnership with developing countries of basic research and phase I trials (EUR 200 million) and clinical trials (under the European Development Clinical Trials Programme (EDCTP): EUR 200 million from the Commission and EUR 200 million from Member States). Through this integrated approach the Commission aims at alleviating the burden of malaria and its effects on poverty in developing countries.

Whilst the Commission supports, in principle, WHO recommended therapeutic protocols for malaria or other diseases in developing countries, it holds the clear view that decisions on such strategies have to be made by the country concerned based on local conditions.

(1) COM(2003) 93 final.