Achieving the goal of medicines for all

Date: 11/12/03

Continuing our series of 'soapbox' commentaries by MEPs for European Voice special reports,two deputies, from the Netherlands and Germany, give their views on the current pharmaceuticals debate

Dorette Corbey believes that propping up the pharmaceutical industry is the wrong way to make affordable medicines available to poor countries

MEDICINES are important and indispensable to the well-being of Europe's citizens. Expenditure on medicines now accounts for approximately 10% of public health budgets.

This proportion will tend to increase due to both ageing populations and the rising prices of new medicines. The current review of EU pharmaceutical legislation will further increase the market protection for drug companies and will consequently affect the price of medicines.

In most industrialized countries, the cost of medicines already represents a sizeable problem for health authorities as they struggle to meet the increasing demand on resources.

These high costs could easily become a flashpoint in political debate very soon unless the current upward price trend is reversed.

An important means of controlling spiralling pharmaceutical costs is to encourage market competition from affordable generic medicines. It is estimated that each year of delay in making such medicines available will cost patients and taxpayers between Û50-Û100 million per medicine.

The pharmaceutical industry argues that medicine prices are high because of the prohibitive costs of research and development (R&D). But statistics show that the pharmaceutical industry is doing very well. The sector's profit margins have been steadily rising and rank among the highest of all sectors.

The very strong position of the sector gives EU legislators every reason to turn their attention to the interests of public health, and little reason to continue topping-up the legislative support already given over the past 15 years.

Indeed, the EU's pharmaceutical industry is trailing behind the much more innovative US industry in terms of new products, but it does not need extra market protection, as it claims, to encourage further innovation.

On the contrary. More protection will only discourage innovation by allowing even greater profits on existing products.

But how will all of this effect other countries with emerging economies, such as the new member states? Medicines are increasingly more difficult to afford for many of Europe's citizens. The pharmaceutical legislation currently under debate will cost an estimated Û400 million per year in Poland alone, and approximately Û1 billion throughout central and eastern Europe.

Admittedly, these figures are the subject of a great deal of controversy. The European Commission claims that European Parliament observers, and health ministers from the new member states, are exaggerating their case, but it has so far failed to provide its own figures on the impact the draft legislation will have on the accession countries' health care systems. Until there is more clarity, and until the possibility of a large price increase can be convincingly excluded, Parliament should support an exemption from the proposed data-exclusivity rules for new member states.

But the story does not end there. In less-developed countries, latest figures confirm the death of five million people from HIV/AIDS. Malaria, tuberculosis, river blindness, sleeping disease and HIV/AIDS have the need for renewed R&D in common - to create new and effective medicines and/or for adapting therapies to conditions particular to developing countries. Third-world patients can ill-afford these therapies, if at all.

International patent law hinders production of cheap generic medicines - a problem that is widely recognized. In August this year, the US, the EU and developing countries reached an agreement on the conditions under which production of generic medicines for developing countries, suffering from a major health crisis and lacking their own capacity to produce medicines, can be allowed.

This agreement now needs to be implemented expeditiously into European law.

The revision of the pharmaceutical legislation presents the European Parliament with an opportunity to help developing countries by supporting an amendment to this effect.

This opportunity must not be allowed to slip away. In short, Parliament should raise its voice - not to protect the interest of industry, but to stand up for the world's most valuable asset - its people.

• Dutch Socialist MEP Dorette Corbey is a member of the committee on the environment, public health and consumer policy and a 'substitute' on the committee on industry, external trade, research and energy.

The Parliamentary review currently under way will ensure more innovation, safety and efficacy for European patients, argues Rosemarie Mueller

THE review of the pharmaceutical legislation aims to ensure the prompt availability of innovative medicinal products of high quality, safety and efficacy at an affordable price throughout the enlarged European Union.

In the interest of the EU's patients, the European Parliament has therefore tried to strike a balance between sufficient research incentives for pharmaceutical companies to develop new, innovative medicinal products on the one hand, and a framework for generic competition on the other.

The future member states have raised concerns about the impact of the review on their health care systems.

In the early and mid-1990s, healthcare costs in many of the future member states rose dramatically. With the upcoming new Europe-wide pharmaceutical legislation, many of these countries fear further increases due to the new data exclusivity rules.

However, the future will be brighter than it looks at first glance when compared with the current provisions of the acquis communautaire, which the future member states accepted in the accession negotiations.

According to the present acquis, a manufacturer can apply for market authorization of a generic after ten years in the centralized procedure, and either six or ten years in the decentralized one.

However, it usually takes an average of a further two years after application before a generic can finally be placed on the market.

The compromise that is now envisaged within the Council of Ministers foresees a data protection period of eight years, plus a two-year period of marketing exclusivity, which can be extended for an additional year in case of a new indication for both the centralized and decentralized procedure. Generic manufacturers can apply for market authorization after eight years, and place the product on the market once the marketing exclusivity has expired after ten or 11 years in each case.

Hence, in the case of the centralized procedure, the provisions of the pharmaceutical review allow manufacturers to market generics on average one to two years earlier than at present.

In the decentralized procedure all future member states have opted for a six-year data protection period, allowing for the placing of generics on the market after approximately eight years.

Since the new pharmaceutical legislation applies the same rules for the centralized and decentralized procedure, generics can be marketed after ten or 11 years, which may indeed imply higher costs on medicinal products authorized in the decentralized procedure.

However, these costs are compensated for by a reduction in data protection of one or two years in the centralized procedure.

In the discussion on health care budgets, one also has to bear in mind that expenditure levels are influenced by a wide range of other factors, such as pharmaceutical consumption, hospital costs or the general health condition of the population, which also need to be carefully assessed.

The prime objective of the current pharmaceutical review is to provide rapid access to innovative medicine for patients all over Europe.

To this end, we require a certain degree of harmonization of the data exclusivity rules. Otherwise we may end up with a situation in which medicinal products will be available earlier in those member states that grant long data-protection periods to pharmaceutical companies.

Obviously, this cannot be in the interest of European patients.

We also want to strengthen the competitiveness of the European pharmaceutical industry and to stimulate research on innovative medicines, not only in the current EU-15, but also in the newmember states.

Some observers in the European Parliament have already signalled that they appreciate the benefits that the review will bring to their countries.

They have indicated that their countries are willing to accept the package, which will hopefully be adopted by the Parliament before Christmas.

• German Socialist MEP Rosemarie Mueller is a member of the Parliament's environment committee and the rapporteur on a regulation that forms part of the 'Pharma' package.

Two MEPs, Dorette Corbey from The Netherlands and Rosemarie Müller from Germany, give their views on the current pharmaceuticals debate.