Bulgaria's health minister Petar Moskov has stated that the Bulgarian and Romanian governments are ready to sign a deal on joint negotiations on drug pricing by the end of the month.
Implications | The prospective agreement between the countries will involve joint negotiations on the pricing of new originator drugs entering the market, as well as co-operation on access to medicines that are in short supply in either country. |
Outlook | The legislative and regulatory complexities of this initiative are considerable, and could lead to delays in its launch. However, it is clear that significant dialogue has already taken place between the Romanian and Bulgarian governments during the past two years on this issue. |
Bulgarian and Romanian governments ready to sign agreement on joint drug-pricing negotiations
Bulgarian health minister Petar Moskov has confirmed in an interview with European Union information portal EurActiv that the governments of Bulgaria and Romania are ready to sign an agreement for joint negotiations on drug prices with pharmaceutical companies, as well as on the availability of medicines that may be in short supply, by the end of September. This follows meetings in Sofia and Bucharest in June and July, in which the health ministers of Bulgaria and Romania began talks with representatives of a number of countries in the regions of Central and Eastern Europe (CEE) and South-Eastern Europe (SEE) over potential co-operation on drug-price negotiations and procurement (see Europe: 12 July 2016: CEE and SEE countries agree on tough joint negotiating stance with pharma firms to help increase access).
Bulgaria and Romania have "highest level of readiness" for co-operation
At present, only Bulgaria and Romania are due to undertake the formal procedure of signing an agreement on co-operation. Moskov is quoted by EurActiv as saying that the governments of Romania and Bulgaria began discussions on such an initiative more than two years ago, and consequently hold the "highest level of readiness" for such an agreement. Other countries may opt to join the existing agreement, or alternatively sign up to a supplementary agreement, Moskov suggested, without predicting which particular countries were likely to do so.
Contents of the agreement
According to EurActiv, Moskov stated that the agreement will be focused on two principal areas. First, it will seek to establish common mechanisms and instruments for the Bulgarian and Romanian authorities in their negotiations concerning new originator medicines coming on to the market. This would mean, according to Moskov, that the combined negotiating teams will potentially be capable of securing larger or more favourable discounts, which could, in turn, assist the marketing-authorisation holder to obtain faster access to the respective markets.
Second, the agreement will involve exchanges of medicines that may be in short supply in either country; thus in the event that a particular drug becomes scarce in Bulgaria – and there are sufficient stocks in Romania – the Romanian authorities will provide their Bulgarian counterparts with supplies of the medicine concerned, and vice versa.
Moskov unconcerned over reaction of pharma industry
When queried by EurActiv on the reaction of the pharmaceutical industry to the initiative, Moskov reportedly stated, "I don't care". The minister added that "sensible discussions" were taking place between the pharmaceutical industry and stakeholders in Bulgaria and Romania, with regard to both originator and generics companies. Moskov conceded that the agreement would need to hold mutual benefits for both payors and producers, and predicted that a notable benefit for the companies would be a "high level of predictability for the business plans of the pharmaceutical companies".
In the interview, Moskov made specific accusations against pharmaceutical companies, which he said were contributing to the lack of availability of certain medicines. He stated that it has been observed that certain drugs considered "gold standard" treatments have disappeared from the positive drug list in Bulgaria, because – according to Moskov – producers bring new, more expensive molecules onto the market that are approved in the same indications, subsequently removing the less costly, older molecules from the list.
Next steps
Moskov is quoted by the source as stating that a body with responsibility for implementing the agreement will be appointed by the end of 2016; in addition, he emphasised that the agreement will require ratification by the parliaments of the two countries. Moskov was appreciative of support from the European Commission for the initiative, while stressing that as a voluntary agreement, the initiative would not become a Europe-wide panacea for the problems of inequality of access to medicines.
Outlook and implications
The Romanian and Bulgarian authorities issued their first announcement concerning co-operation on the joint procurement of expensive medicines in June 2015. As two of the European Union's economically least-developed nations, Romania and Bulgaria are particularly challenged by the growing cost of providing effective new medicines to their populations. Additionally – since in both countries various measures implemented in recent years have resulted in low drug prices compared with the EU average – the two states are also facing shortages of some drugs due to parallel exports, as well as withdrawals by producers. Since these problems are also faced by many other countries in the CEE and SEE regions – not only EU members – the initiative begun by Bulgaria and Romania has been opened to other nations, although it is not clear how many of these will participate. The level of international participation will become more apparent after the third meeting of representatives from the CEE and SEE countries, due to take place before the end of this month in Warsaw.
Petar Moskov has previously taken umbrage with the pharmaceutical industry: soon after assuming office, Moskov accused pharmaceutical companies of "blackmailing" over pentavalent vaccine supplies; however, he concedes that any agreements reached with producers must be mutually beneficial. The structure that negotiations with producers will take remains to be seen, and predictions as to how talks will progress are difficult.
The most significant question raised by the initiative is that of the Bulgarian and Romanian governments' strategy for overcoming the significant legislative challenges to implementing the agreement. A legally sanctioned joint system of evaluating drugs for reimbursement and pricing must be established; this will by no means be straightforward, and could mean that the process of launching the initiative will be delayed.