Health ministers from Central and Eastern European, and Southeastern European countries have held a second meeting to discuss co-operation on co-ordinating approaches to the problem of access to high-cost medicines, and have agreed to take part in joint price negotiations.
Implications | Ten EU and non-EU countries have already signed up to the agreement, with two others likely to do so. Until now, oncology, orphan, and high-cost drugs from other groups have been discussed for involvement in the negotiations. |
Outlook | Concrete details of how the negotiations will take place, and what their criteria or methodology will be, have yet to emerge. However, it is clear that there is a definite need to address the problems with the free and open market for pharmaceuticals in the European Union, which result in a substantial deficit of access to new medicines in lower-income nations. |
On 8 July, health ministers from 10 Central and Eastern European (CEE) and Southeastern European (SEE) countries met in Bucharest in a second meeting of a new co-operation programme aimed at tackling the problem of access to medicines in these countries, associated with the divergence between prices in established EU markets and those in newer EU member states (although it should be noted that three of the countries involved were not in the European Union). According to Romanian medical news provider Sanatatea Buzoiana, the following countries have already signed up to the agreement: Romania, Bulgaria, Croatia, Latvia, Poland, Serbia, Slovakia, Slovenia, Moldova, and the Former Yugoslav Republic of Macedonia. The source reports furthermore that talks with representatives from Estonia and Hungary about joining the group are at an advanced stage.
Countries aim to ensure lower prices, fewer withdrawals
According to the source, Romania's health minister Vlad Voiculescu stated at the press conference following the meeting that 12 European countries would sign up to the agreement – presumably meaning the 10 that had already done so, as well as Estonia and Hungary – and that the agreement would involve the adoption of a tougher, unified negotiating position with the pharmaceutical industry, with the aim of ensuring lower prices to increase patients' access to innovative medicines. Another aim of the agreement, according to Voiculescu, is to ensure that producers will not withdraw cheaper medicines from the market so willingly because they do not think that they can make a profit from them.
Joint procurement planned
Voiculescu is quoted as saying that at subsequent meetings, the representatives of the 12 countries will collaborate in working groups and develop agreements to purchase medicines jointly, at these prospective lower prices. The minister stated that concerning pharmaceutical companies' decisions to withdraw medicines from a market, they may do so if the market concerned has around two million, or even 20 million, inhabitants. However, he said that if the market comprised 100 million inhabitants (a rough figure for the combined population of the countries involved), the producer would be unable to afford to do so.
No plans to interfere with existing IRP system
Sanatatea Buzoiana quotes Voiculescu as saying that representatives of the European Commission who attended the Bucharest meeting welcomed the initiative, and saw that the attempt to find solutions to the problems of patient access to medicines as important. He is reported as saying that the agreement will be compliant with the EU's regulations on a free and open pharmaceutical market. This is echoed by Bulgaria's health minister Petar Moskov, who is quoted by Bulgarian medical news source Zdrave.net as saying that the system of international reference pricing (IRP) will "not be touched". Moskov also echoed Voiculescu's statements regarding the greater weight and influence the countries involved would have when joined together to prevent producers from withdrawing their products.
Oncology, orphan, and other expensive drugs to be involved
Petar Moskov stated that the current system of price formation in the EU was unfair to CEE and SEE countries. The source reports that until now the participants have discussed three main drug types: oncology drugs, drugs to treat rare diseases, and other expensive drugs from different groups. Zdrave.net reports Moskov as saying that the participants are at the advanced stage of completing a draft agreement establishing the parameters and methods of joint activities of the countries involved in negotiating with the pharmaceutical industry when a new medicine enters the market.
There will be a third meeting in the Polish capital, Warsaw, in September, Moskov stated, adding that the aim was to finalise terms by the end of the year, so that the mechanisms agreed upon could come into effect from the beginning of 2017.
Outlook and implications
The first meeting of this co-operation programme, an initiative of the Romanian and Bulgarian health ministries, was held in June in the Bulgarian capital, Sofia (see Europe: 8 June 2016: CEE health ministers seek joint solution to parallel export challenges). Although no concrete details have yet emerged of how the agreement between the countries will function, there has already been progress from a more general discussion about drug-policy convergence to a definite plan to start joint price negotiations.
Under the EU's free and open pharmaceutical market, lower prices in CEE and SEE countries give rise to high levels of parallel exports from these countries to higher-price countries in Western Europe and Scandinavia, which results in shortages of drugs in exporter countries. Furthermore, the low prices in CEE and SEE countries also result in some producers withdrawing their products from certain countries in these regions, judging it to be uneconomical to market their drugs in these nations. Smaller populations mean that these producers may consider it unworthwhile to sell their drugs in the countries concerned. Producers may also simply not launch their drugs in countries where the prices they are offered are seen as too low, and could affect their prices in higher-price markets, owing to international reference pricing (IRP).
It remains unclear how the health ministers from the countries involved propose to implement a joint negotiating strategy that can also be compliant with the free and open pharmaceutical market of the EU, but there is certainly a very good moral reason for their attempts to do so. Owing to IRP, producers are unable to offer radically lower prices for their medicines in CEE and SEE countries, while the industry itself has argued in favour of allowing differentiated pricing between lower-income and higher-income markets.