To date the focus on access to medicines has understandably concentrated on the critical need to provide affordable medicines to developing and least developed countries. However, new EU pharmaceutical legislation presents a threat in the accession countries, which are highly dependent on non-brand name medicines at low cost, according to Greg Perry of the European Generic Medicines Association.
While the much-discussed TRIPS Agreement threatens access to medicines in the world’s poorest countries, the current review of EU pharmaceutical legislation is a menace "closer to home" for the 10 new "accession" states.
Among the various pharmaceutical proposals from the European Commission’s is a controversial measure that seeks to increase the overall EU protection period for branded pharmaceuticals. This would be done by extending the so-called data exclusivity period during which it is not possible to make an application for a generic equivalent of brand product in the EU.
It is important to note that the data exclusivity period:
Is granted in addition to any patent or patent extensions.
Is not based on proof of innovation.
Cannot be challenged.
Since applications for generic medicines take two to three years to complete, any increased delay in the start of a generic application is likely to result in preventing the more affordable generic equivalent from entering the market immediately after patent expiry.
According to generic companies, up to 50% of products expected to be launched in the EU could be delayed beyond patent expiry as a result of this European Commission proposal. The effect will be most harmful in smaller EU countries, which operate less restrictive data exclusivity periods on generic applications.
Critical to Central and Eastern Europe (CEE)
The negative implications of this data exclusivity extension for countries of Central and Eastern Europe will be damaging for two main reasons:
Generics medicines are a critical part of many CEE countries’ health care policies. They account for 70% of volume but only 30% of costs of the pharmaceutical budget. The remaining 70% of the costs pays for more expensive brand products, which make 30% of volume.
Most CEE countries simply do not have the ability to pay the cost of increased medicines prices. Average GDP per capita in CEE countries is one-fifth of the EU average and real spending per capita on health in CEE countries is less than 400 Euro compared to over 1,600 Euro in EU.
Without generic medicines, these countries cannot afford to provide pharmaceutical care. But does the EU care?
Raw deal
Candidate Countries got a raw deal on pharmaceuticals during the accession negotiations. They agreed to support the interests of Big Pharma in EU markets by preventing parallel importation of brand products into the European Union while the EU countries granted nothing in exchange. On the contrary, Candidate Countries were forced to introduce EU legislation granting up to five years’ patent extension to pharmaceutical brand products authorised even before the date of accession.
The "wealth divide"
This is very sad reflection on the EU, especially since the total value of the markets of Candidate Countries represents a very small part of the overall European pharmaceutical market. What is surplus profit for major EU, US and Swiss pharmaceutical companies is a major loss for health care systems in these countries. One cannot underestimate the current health care crisis in countries such as Poland and Hungary where nurses are earning as little as 200 Euro a month.
The situation for Big Pharma is altogether different. According to the Financial Times in May 2002, "Pharmaceuticals maintained its record as one of the fastest growing and most reliable industries in 2001…In Europe, where the big companies have complained bitterly about pressure to reduce prices, sales were 10 per cent higher at $88 billion". The breadth of the wealth divide is also illustrated by the fact that whilst a CEO of a leading multinational pharmaceutical company is seeking a personal salary package of US$18 million, the Minister of Health in Poland would be using the same amount to employ 6,000 nurses for a year.
It is not surprising that the issue of data exclusivity and the impact on access to medicines in the EU and CEE countries is so controversial. To its credit the European Parliament in its First Reading on the Medicines for Human Use Directive in October 2002 passed an amendment reducing the Commission’s proposed time delay for generic applications. This amendment was passed by a staggering 455 votes to 55. However, the European Commission has already stated that it will not change its proposal on this point thus ignoring a clear statement from MEPs.
In the Council of Ministers, small- and medium-sized EU Member States are expected to oppose the European Commission’s data exclusivity proposal but they might be "out-gunned" by bigger EU Member States who have strong big pharma interests. Unfortunately, for Candidate Countries they cannot at present directly affect this legislative process even though it will have direct impact on their health care policy. In fact, if the 10 Candidate Countries were voting today its is certain that the European Commission proposal would have no chance of success, since all Candidate Countries indicated during Accession negotiations that they would opt for the current right available to EU Member States to take a less restrictive time frame on generic applications.
Not surprisingly Big Pharma want to get the new law singed and sealed before the enlarged EU is born. Our job in the EGA, which represents both the EU and CEE generic medicines industry, is to convince policy makers to look beyond the narrow interests of brand-based companies and to see the wider picture of guarantying access to medicines to all patients in the New EU of 25.
Info
Greg Perry, Director General
European Generic Medicines Association
PO Box 193, B-1040 Brussels 4
Tel: +32 2 736 84 11, fax: +32 2 736 74 38
E-mail: info@egagenerics.com
Website: http://www.egagenerics.com
