Speech on Access to pharmaceuticals in Eastern Europe
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17.03.2011

On November 18, 2010 EATG's Policy Co-chair Raminta Stuikyte presented the attached speech on Access to pharmaceuticals in Eastern Europe at the conference "Can We Afford the Current Model of Innovation: Towards New Models of Innovation" in the European Parliament.
http://www.eatg.org/Policy-Advocacy/Conferences-and-meetings

Speech with references please read at http://www.eatg.org/eatg/content/download/18632/144497/file/Stuikyte%20-%20Access%20to%20pharmaceuticals%20in%20Eastern%20Europe%20speech.pdf
Thank you for the opportunity to contribute to this meeting with a perspective from the new EU member states and neighbourhood. I will speak about problems there and less about solutions for balancing access and innovation.
Bulgaria, Latvia, Lithuania, Poland and Estonia – all new member states - have the lowest healthcare budgets per capita and highest death rates within the EU. We citizens in those countries may be paying less for staff and hospital expenditures, however our smaller budgets have to accommodate costs for pharmaceutical products and lab equipment which are as high as elsewhere in the EU. Naturally, this has major implications in terms of health inequalities, like a 50% higher combined standardized death rate across diseases. In addition, in order to be treated, many of our patients have out of pocket expenses to receive the medicines they need. For example, in my home country Lithuania up to 66% of all costs for medical supplies are covered by patients themselves. This would be unacceptable for many EU member States.
Thus, we have to stop cutting health budgets and spend more on health care from public funds in order to increase access to medicines and diagnostics. Furthermore, other drastic changes would need to take place for us to be able to receive medicines when we need them. Let’s have a look at two diseases – hepatitis C and HIV.
Hepatitis C is a hidden disease, since it is often asymptomatic. The current treatment standard is a combination of two medicines, pegylated interferon-alpha and ribavirin. There is a patent held on pegylated interferon-alpha and the price, which is solely defined by its two manufacturers, is prohibitively high: from 10,000-20,000 EUR per 48-week course in both developed and developing countries. In the neighbouring countries, like Ukraine, Georgia, prevalence is high but neither governments nor insurance schemes cover hepatitis C treatment.
New EU member states might do better but they too have major access issues which were documented earlier by the Eurasian Harm Reduction Network. A limited number of treatment courses are available in my own country, Lithuania, and some recent positive change is that patients no longer have to co-pay for treatment. In Latvia, treatment is available only if someone co-pays for it. Four years ago, people had to copay 25%, since 2010 they have to co-fund half of the price. Prices vary substantially across countries. The Harm Reduction Network’s analysis found that the Czech Republic was found to pay almost double the price in comparison to other new member states (20,000 EUR).
Thus high price is a major obstacle for increasing access to this treatment. At the recent regional workshop on access to essential medicines in Eastern Europe and Central Asia and on other occasions activists, practitioners and researchers also point out that in theEast it is hard to draw attention to the issue, as there is no recognition of the issue at the political level – and although there is abundant indication of the issue if one would want to acknowledge it, we simply do not have robust enough data available to show mortality or prevalence rates, also as 80 and more percents of cases remain undiagnosed.
HIV has received more attention than hepatitis C. It is on the global and EU agenda and is part of the Universal Access and Millennium Development Goals which all our countries have committed to reach by respectively 2010 and 2015.
In the new EU member states, coverage of life saving HIV treatment for those in need is below 50%, thus lower than in some neighbouring countries like Georgia or Moldova. In Latvia, only 15% of those in need for treatment receive it, 22% in Hungary, 38% in Estonia, according to the UN and the ECDC.
At the same time, Latvia has the highest mortality rate among people living with AIDS among the new EU member states.
Also, along with Estonia, Latvia has the highest rates of new infections. This is not surprising, given that the prevalence is higher than in most EU countries and also the fact that people who receive treatment are less infectious.
The key issue our new EU member states are struggling with is the high cost of medicines. The medicines are rather new and cost around 4,400 EUR per year just for the cheapest first line medicine cocktail. And here one needs to remember that HIV treatment does not represent a cure and needs to be continued throughout a HIVpositive person’s life. Outside the EU, it looks as if in terms of pricing Eastern Europe is doing much better than the EU: Ukraine managed to reduce the first line therapy to less than 230 EUR (300 USD) per patient per year. So why does Estonia, Latvia, and others pay 19 times more than Ukraine? For one, Ukraine and other Eastern European countries still can introduce good quality generic medicines for many antiretrovirals which are cheaper; secondly, pharmaceutical companies that produce original ARVs set differential prices based on regions, income (GDP, World Bank classifications) and epidemic levels. But once countries join the EU, prices there change and rise to the EU level, without differentiating by income or epidemic levels that is burden of the disease in question. The single Internal (EU) Market basically implies a single level of reference pricing, particularly for newer and more expensive medicines.
In the EU, some attempts to address the pricing issue for antiretrovirals have been made - under the leadership of the European Commission, then also Germany. Over the last two or three years, several rounds of high level and operational meetings with a few countries took place. In July 2010, the European Commission singled out Bulgaria as a good practice case. Surprisingly, Bulgaria reported that after two years of discussions they managed to reach a ‘good dialogue with the pharmaceutical industry,’ however, it seems that in terms of price they have not managed to reach any reduction so far.
The main reason why new EU member states cannot import cheaper anti-HIV medicines, like generics that are used in Ukraine, is a long protection period of clinical and preclinical data, so-called data exclusivity, which is established in the European legislation. The rationale provided for it, as well as patents for medicines in general, is the alleged need claimed by pharmaceutical companies to recover the costs of R&D and innovation, in addition to covering for other costs which are paid also for generic medicines - manufacturing, marketing and profits of the pharmaceutical industry.
Access and innovation are both important. Therefore the European AIDS Treatment Group advocates for the fastest possible access to standard of care treatment for everyone in need – whether inside the EU, living in Eastern Europe, Central Asia and elsewhere. Too few of us receive HIV treatment in Latvia, too many of us in Romania experience drug stock-outs that threaten our lives. Thus we need to urgently rethink how we can better support access which falls under the responsibility of national governments which often fail to provide it. And we need to rethink how to better support innovation so that patients from new EU member states can eventually access the treatment they need, including TB patients or patients suffering from other rather neglected diseases, which are killing us in the East and in many other places outside the EU – so that these diseases would get adequate attention in research. In the meantime, we should not export our high-brand medicine protective policies through EU trade partnership agreements - neither to neighbouring Ukraine, nor to the pharmacy of the world, India – but work on balancing access and innovation within the EU as well.