Is data-protection for medicines generically flawed?

Date: 15/04/04

The European Parliament adopted new EU pharmaceuticals rules last December, including a ten-year data-protection period for conventional medicines. However, at present this can be as low as three years in some accession countries, where the use of cheaper generic medicines is more widespread. Two observer MEPs reflect on the system ahead of enlargement.

Arguments against the data-protection system ignore economic realities, says Miroslav Ouzky

ALTHOUGH many of my fellow observer MEPs lobbied hard against a proposed ten-year data-protection period for conventional medicines ahead of last December's key vote on the EU Pharma package, I believe that they were failing to see the big picture.

I also believe that we will not suddenly be faced with a health care crisis in the new member states after we join the Union in May and the new rules are applied across the board, although they will not be transposed into national law until 2006 at the earliest.

Yes, it is true that data exclusivity periods have historically been lower in the accession countries, many of which produced usually cheaper generic medicines for the entire former Soviet bloc during the communist era and continue to boast big generics' businesses.

But I totally disagree with the views of some of fellow observers, because I think it is not so easy to paint such a black-and-white picture of this industry. My party is interested in protecting private property and promoting a free market ethos, which would be hampered in my view by giving the new member states more time to adjust to the new EU Pharma rules, as Dutch MEP Dorette Corbey suggested in the amendment she tabled last year.

In such a difficult market and industry, and such a complex debate, nobody can say it's either '100% like this or like that'.

To be sure, we can protect a specific product from time to time, and I am not opposed to generic medicines, but I see no reason to create a different market in the East from the West - uniform rules should apply across the board to create a level playing field for drug manufacturers.

Because the upshot of an extension of lower data exclusivity periods for the new member states, as MEP Dorette Corbey unsuccessfully called for (her amendment was struck down), could be very bad for the region - and Europe as a whole - in the long term.

Innovation could suffer as nobody invests in research and development in the health field, and that could be very dangerous.

Moreover, it is important that consumers realise that generic medicines are not always that much cheaper, at least according to figures I have come across for the Czech market, where if you compare generic medicine to original medicine prices the former are just 10-15% cheaper. But it is my understanding that generics' producers could offer even more savings, of up to 30%.

So in the Czech market, the prices of generics and branded medicines are nearly the same. But I think that is an angle that is not often presented.

I agree that we can discuss changing the data exclusivity period by one or two years (up or down from the current ten-year period).

But, in my view, we need to see the big picture, not just a specific problem reflecting the short-term concerns of the generics industries of Poland, Hungary or Slovenia.

If you develop a new product you should have the right to be protected in the medical policy field for some time.

I have nothing against generics, but I don't think those seeking to protect the generics industry and market have based their arguments on a firm economic foundation.

• Miroslav Ouzky, of the conservative Civil Democratic Party, has been a member of the Czech parliament since 1998, where he chairs the social affairs and health committee. In the European Parliament, he is an observer MEP to the economic and monetary affairs committee and has followed health policy.

Drug prices will go up - it is as simple as that, warns Gyula Hegyi

DURING the one year's period as an observer MEP I found the new Pharma package the most interesting issue of my work in the European Parliament. I had not been an expert in the medicine debate before, but, confronting the problems of the new legislation, I had to learn at least the basic facts about medicines, particularly the generic industry.

Before the transition to democracy and a market economy, medicines were relatively cheap in Hungary. The social security system subsidized them and pharmaceutical factories were owned by the state. The medicines imported from the West were more expensive, but most of them could be replaced by Hungarian-made generics and brand names. After the changes, the prices went up rapidly. People pay three to four times more for their medicines than before. Many pensioners or parents with sick children regularly spend some 15-20% of their income on medicines.

That's why I protested against the extensions of the data exclusivity period in every possible forum. The new package, in its 'Grossetete version' [MEP Francoise Grossetete was a rapporteur for the Pharma package] will result in a significant increase in expenditure related to drugs by the social security scheme and the public alike.

By our experts' calculation, the annual turnover difference would be 15 billion Hungarian forint, roughly €60 million. As the social security scheme already has a huge deficit, this difference would be covered either by the state budget or by the population. As a result the poor people, whose health status is traditionally worse, will only be able to access the most up-to-date and effective products after an even longer period of time.

By increasing inequality of opportunities, this measure will worsen the exclusion of those living in poverty. One can say that €60m per year is not a big sum. But, despite the nice slogan of 'social Europe', mostly the less well-off strata of the Hungarian society paid the price of the accession process and the requirements set up by the EU. The new regulation regarding generic medicines is just one more abuse against them.

Certain legal considerations should also be taken. In 2003 Hungary signed and ratified the accession treaty with the old pharmaceutical regulation, and until May 2004 we don't have a vote in the European Parliament.

I find it very unfair to pass this kind of legislation in this 'ex-lex' period when we don't have any democratic right to vote about it. Dutch MEP Dorette Corbey tabled an amendment under which the new member states may reduce the data exclusivity period to a formerly specified six-year period by a single member state decision, "where it considers this necessary in the interest of public health".

Hungary would have enough arguments and evidence to show that - at least in the coming years - it is really in the interest of public health and people in need to reduce this period. Hungary has an old tradition in pharmaceutical science and manufacturing.

If we reach the average standard-of-living level of the EU, we are ready to pay the price of the original brand, innovative medicines included. The issue has taught me that the nice speeches about solidarity for the newly freed countries are over and now the hard talks begin.

• Former journalist Gyula Hegyi is the founder of the Hungarian branch of Amnesty International. Since 1994, he has been a Socialist Party member of the Hungarian parliament and vice-chairman of its environmental committee. He has been an observer to the European Parliament since May 2003.

Two observer MEPs consider new European Union pharmaceutical rules adopted in December 2003, which include a ten-year data-protection period for conventional medicines. At present, this period can be as low as three years in some accession countries, where the use of cheaper generic medicines is more widespread.