Dr Antonyia Parvanova, a physician, is a member of the Parliament’s Committee on the Environment, Public Health and Food Safety. She spoke to EurActiv Senior Editor Georgi Gotev.Click here to read a related news article.
Let’s talk about the need for transparency in the member states’ policies to control the prices and the reimbursement of medicinal products. The Commission came forward with a proposal in March this year. In the European Parliament proposals are currently making their way, and you are the rapporteur on this important subject – the Transparency Directive. What is the directive trying to achieve, what are the abuses in the system at the moment?
There are several interests which are included in the initial idea of the Commission to come up with such piece of legislation.
It has been seen as mainly pro-industry because the main debate goes between the innovative and the generic industry. And the different techniques are sometimes against the common market rules and uncompetitive practices, which they use at the national level to protect their products or to include them in the pricing reimbursement list.
This directive is also covering the patients’ interests because it’s very clear that the sooner the product is included in the pricing and in the reimbursement list, the sooner the patients will have access.
What are the techniques in the uncompetitive prices, let’s call it, and what is going on behind closed doors? First of all, all the member states have different practices, and legislation related to the inclusion of innovative [drugs] and generics into the price and reimbursement list. In some of the member states this is one in the same list; in different member states they have two different lists, two different bodies and two different procedures for both of them, which is causing of course enormous delays.
The untransparency in the whole set of practices and procedures - it’s not only in the administration untransparent, but also the untransparent practices which the companies sometimes use against each other. Like abuses related to the delays of generic products, which is practiced by some of the companies. To put to the court claims against the generic companies for breach of the patent law or the patent expiry date, or different types of pressure towards the administration to delay the inclusion in the pricing or reimbursement list, because of fear that inclusion may interfere with the financial constraints or may expose the national health insurance to some pressure, and some shortages may occur.
All these are acceptable as arguments, especially from the side of the national authorities, but it’s unacceptable in terms of transparency and in terms of clear rules and protection of the interests of patients.
Also, it’s unacceptable that the pricing and reimbursement procedures are mixed with marketing authorisation elements which are also sometimes interfering and causing delays.
Can you give some examples?
For example, those companies which are submitting their documents for particular products for inclusion in the pricing and reimbursement, sometimes are required to present documents which are already or have already been presented when they got their initial marketing authorisation, which are the safety and efficacy issues. This is kind of double procedure, but it’s more a tip for delay, and it’s causing a delay, but it’s unnecessary so this is one of the issues that this directive is also sorting out. The practice also shows there are incredible delays which sometimes amount up to 780 days, which is almost two years, just to look at the documents of the companies for inclusion of the price and reimbursement.
And this is why the intention of the Commission was to first of all, to justify the procedure between all the authorities on the territory of one national state, and to have one and the same procedure and clear transparency for the companies and patients in all member states. Then also to try to prevent unjustifiable and unjustified delays, by putting clear time frames. Even the Commission went one step further – with the so-called remedies or putting penalties on the national authorities which are causing these unjustified delays.
This is the first sticky point I should say in this directive. The second bottleneck in the directive is the idea that the member states should report to the Commission of changes they intend in corresponding legislation not only on the time of transposition, but even further, which happens sometimes very often and it’s also causing a delay. But you can imagine first of all, there is no such practice on the territory of the union on any other legislation, not only related to pharmaceuticals, but also in the whole legislative practices and transposition practices, and the member states are not very happy because there is lack of trust. Like they are not able to transpose correctly the directive and that’s why they have to report to get … approval from the Commission, and then to put it up for a vote in the national parliament.
This directive looked, at the beginning, blocked because there were more member states expressing worries than those which are supporting it. And mainly for financial constraints and probably because of the reason that the directive will put some deadlines for the inclusion of a pricing and reimbursement list, which will of course affect the annual budget of the corresponding institutions, or the one that is envisaged for the current year.
But the more we discuss and the more we clarify with the Cypriot presidency - and talking even to the member states which are expressing their concerns - we could find a way through and also find a common interest and a balanced approach. And I think we should be able to come up with very good quality piece of legislation which will really contribute significantly to the whole procedure of a very contradictory area of pricing and reimbursement of medicines, which actually has been subject to severe criticism.
Can you name member states that have specific concerns or are reluctant to harmonise further?
There are different sets of member states which are expressing concerns about some of the provisions of the directive for this bottleneck that I mentioned. I could name some countries, but it would be unfair, because the situation is dynamic. Some of them have actually shifted to more flexible positions. It also depends on the practices in a member state.
Is it possible to imagine that there will be transparency in the sense that one can go on a website and see the prices of medicines, the percentage of reimbursement in different countries, to compare?
As I said, there is no legislation which is harmonising all this at the EU level. The main problem is not to have only a website. The main problem is that there is no clarity on the procedures of the inclusion of medicines in national reimbursement lists. Nobody knows actually what are the real terms, what are the conditions and what are also the considerations that the national authorities may put forward for the companies. Sometimes there are cases in which national authorities are exceeding their competences and asking, for example, information about the shareholders of the companies etc. All kinds of weird things.
Or there are member states in which a claim of the company originator of a product is stopping the whole procedure of pricing and reimbursement for a generic product in one member state and it’s not the case in another member state.
This is what we call unjustified. This is what has been detected by the analysis made by the Commission and there was a report on this on the main practices which are causing these delays. There is a very good summary issued by the Commission, and I think the data are showing clearly that the legislation and more transparency is needed. Otherwise, at national level, if a member state was to enhance their procedures, they could do so.
But inequalities and disparities are the main problems, because now with the parallel trade and with the opportunities of the national authorities to use the so-called reference prices, it is becoming more and more impossible to hide prices. Because if a ministry is calling another ministry or a range of ministries for prices of medicines, they usually get them, and they become terms of reference when the national legislation is envisaged. This means that there is no difficulty to find out what are the differences in prices, but still the companies are having their arguments of saying that the national markets are different, and because of this, they should protect their national prices which may significantly differ.
As I said with the parallel trade, the argument is becoming more and more invalid and unreasonable actually, because although a company would like to trade their product at a certain price, the parallel trader could actually bring to the market as wholesale the same product from a member state where the prices are lower. To this extent, parallel trade, although it is causing various problems, is a little bit disciplining the market.
There is a lot of money involved in this business. As a member of the Parliament, are you lobbied a lot?
Oh, yes. That’s absolutely true.
Everything that is related to pharmaceuticals, tobacco and alcohol is a subject to severe lobbying here in the Parliament. Agricultural products as well. These are the main areas and almost everybody is lobbying now, as regarding the price transparency. People from universities or different consultancy companies who are calling for meetings, sending e-mails, opinions etc.
But I should say that we happen to take a very strict approach. First of all, I met with the Commission, with the Council representatives and the [present] Cypriot and [the next] Irish presidency. Then I met with both associations - the innovative and generics - to make absolutely clear that we will play with open cards. And I also met with civil society, patient and consumers’ organisations and with professional organisations - doctors, nurses etc. - to make absolutely sure that everybody who has an interest in this process will be able to bring forward their concerns and proposals, and to avoid our office to become the main arena for conflict of interests.
That’s why I think this is the only way to be efficient and I fully agree also with the main concern of the national authorities that if this directive is not done in the best possible way, it may cause even more problems at national level, but also it may expose the national health budgets to some challenges.
In terms of timing, if everything goes well, when do you expect the legislation to be in force and how do you describe the result of the legislation if everything goes well? Would it result in a drop of prices, more harmonised prices?
Usually with the short procedure, the easy legislation goes into a trialogue after the first reading. I don’t know whether this procedure would be possible in the case of the price transparency directive, given the fact that there are many member states still hesitant about it. But after it goes through the whole procedure, the directive is envisaging three years of implementation, which means that there is enough time for the member states to amend not only the legislation, but also to catch up with the necessary procedures with the national authorities.
In terms of prices, the effect will be mainly in terms of shortening delays. You see, even if a product has passed the market authorisation procedure, this still that does not mean that the product could be on the free market or the reimbursement market. If it is not included in the pricing list, it’s not marketed. If it is not included in the reimbursement list, it’s not reimbursed. And the main delays are actually when the companies are asking for a price to go through the pricing procedure and also for reimbursement.
There are new products all the time, while often national authorities are updating their reimbursement list only once per year, which is exposing the patients to limited access to innovative medicines, but also to cheap generics. Less access to generics is actually causing more burden and financial burden to the reimbursement schemes.
That’s why the delays are having more of a financial impact to the whole system and to patients’ access instead of to the single price of a product. The single price of a product will be put on a more transparent footing because of the whole procedure of announcing the application for the pricing procedure, but it’s not something that is subject to specific provision of this directive.
The special contracts are more disputable than the prices of the regular medicines. There is not that much lack of transparency of the prices of the medicines that are on the regular lists. Only those that are subject to contractual agreement and therefore excluded from the scope of this directive could be subject to critics.
Do you feel any impact of the economic crisis? Health budgets are under strain in individual countries…
Is it something you are taking into account?
Yes, it has been discussed, actually. I had the opportunity to discuss this in person with Commissioner John Dalli because he is not only a Commissioner on health, not only a former minister on health of Malta, but also former finance minister. So he is someone that more than anybody understands the contradictory public engagement of a health minister and a finance minister.
But anyway, what we have seen recently is that the health budgets are those which are subject to the first glance of restrictions. I don’t know why all member states decided to start with the financial restrictions of the health sector, probably a reform is needed, but to me less money does not make more efficiency. Probably more efficiency could bring to some savings, but not vice versa.
A pure example of this is for example the debate on the Health for Growth programme. The Parliament would like to see more and more activities covered by the Health for Growth programme, to give an opportunity for the next multi-annual financial framework to the member states to utilise money for better provision of health services, better access, for better health for the citizens. But the member states first of all have to limit those activities and try to limit also the financial portfolio.
You can imagine, just as an example because you asked me about the lobbying, just as a comparison, the whole financial portfolio for the health for growth programme is about €300 million for the period of six years, 2014-2020. This means about €50 million for 28 member states per year for public health programmes, which should have significant impact in health and equalities or disparities in the access of citizens to health care. At the same time, the annual budget of the alcohol companies for marketing and promotion only in the UK for one year is €800 million. Only in the UK.
So we are running against the wind.
It’s something that requires us to reconsider our priorities. That’s why there is more and more a call in the Parliament from different patient organisations to cover their problems. Because there is no opportunity in the treaty to cover health in the EU agenda.
More and more member states are claiming that this is a subsidiary issue, although I think they are abusing this a little bit. They have also cut the health budget. Now you can imagine that because of lack of EU legislation, lack of EU practices, lack of common EU policy on health and public health, each patient organisation should come and lobby for more attention about their problem and sometimes there are severe problems such as leading to different life expectancies for women. Eight years between the best and the worst. For men, 14 years between the best and the worst.
And it’s not the same if you are born and live in a poor member state with fewer opportunities to get good access to quality health care and to one which is more advanced than this, but there should be no difference for our citizens. Then it’s even worse with years spent in the healthy years of life, the years without disease, where there is 20 years of difference. And again this should put the question: isn’t it time to talk about public health as part of the common EU policies and common EU legislation as well in a very structured way? Not as trying to cover issues related to safety of medicines, issues related to organ donation or occasional opportunities to issue a resolution which is bringing attention to one or another topic of severe inequality like for example cancer or chronic deceases.
This is an unsustainable way of dealing with such an important matter. I think that sooner or later, the Union will come up to a stage of development when more publicly directed policies will be more fashionable for not only national governments, but also for the EU institutions. Because a lot has been done over decades for the industry and it’s obvious that so far the Union is not in a good shape, although and despite our efforts to boost the agriculture, industry etc., etc. But we haven’t paid to much attention to fundamental rights and one of them I think that definitely deserves attention is the right to health.
Maybe this is the right time to raise the issue, now that everybody speaks of rethinking the European Union and a possible convention leading to treaty change?
That’s absolutely true, but still I’m concerned that all these ideas of a new treaty and new combinations of countries that may join that treaty, are still around the economic interest and still around the eurozone, and still around the banking sector, still around the stability of the euro or the common market etc. And I don’t hear anything about the citizens. I think that the citizens are not going to…
To buy it?
Yes. They are not going to buy such a policy because they have already shown their attitude when they vote for the European elections. Just 30-35% are interested in voting in European elections, which means that European decisionmakers do not deliver. To get better confidence from EU citizens, we have to work on different issues, not just protecting somebody’s apples, somebody’s wine, somebody’s milk, cereals, cars, etc.
The question will be what is in the treaty for me?
Yes, and there is nothing in the treaty about somebody’s job. Nothing about somebody’s health. Nothing about somebody’s education. Nothing about somebody’s basic rights as a human being, as a citizen.
Another issue I would like to ask you about is health literacy. You are writing a report on this, what are the challenges for health literacy in Europe? I’m thinking of vulnerable groups, for example, but also for the normal citizens. Sometimes we are very good in our profession, but we know very little about health …
That’s a subject that can have been neglected by the EU and I’m very glad that the European Commission has financed a project led by Maastricht University, so far in nine member states, which is looking at the different manner of appreciation of health and health-related issues, even health institutions. And the figures are very interesting because they show that there are no risk groups, there are risk countries. Like for example, there are two categories of citizens which deserve special attention. Those who have inadequate understandings and ideas, and problematic understandings and ideas, about three issues: about their health status, about the way that the health system is functioning, and about health prevention and health promotion.
And the figures are pretty shocking especially given the fact that 25% to 50% of the people in Europe or in some member states are having problematic and inadequate understanding of their health.
In my own country, Bulgaria, more than 60% of the people are having problematic or inadequate understanding about health prevention and about health promotion. This refers to what they should do about themselves to keep themselves in a good shape and healthier.
If the people do not understand correctly topics related to their health and what they should do about themselves, then we are exposing at risk all our public health programs. And whatever is the financing, if the people do not understand, if they do not follow, if they do not appreciate, then we will still have failures. The health inequalities are following the same manner. The less the health literacy of the population is, the more inequalities occur and, less access, less literacy, less appreciation of health-related topics are causing more morbidity and mortality in a member state.
Can you give an example of bad practices because of health illiteracy? I’m thinking for example somebody who thinks that to cure his flu he has to drink a lot of alcohol …
That’s one of the very good, dangerous examples, but I can give you one even more cynical. Recently, there has been a big campaign for vitamin or additives substances added to cigarettes, making them “healthy”. So you can imagine, to me it’s sick. Completely sick. I don’t know whether someone could believe that the vitamins added to the cigarettes will enhance their health, but it will definitely enhance their way to poor health. Still those kinds of things happen.
And there is a belief that the vaccination in general is a bad thing, and there is a big campaign against vaccination. You can imagine if we had followed such a campaign, we should still have been in the 17th or 18th century, and dealing with smallpox or tuberculosis, but still because of failure in vaccination, tuberculosis is on the rise and some other deceases as well. We do not cover our elderly people with vaccination and they unnecessarily are exposed to the different flu epidemics.
Your country Bulgaria, it’s the EU’s poorest country and life expectancy is also very low there. There is probably a link between the two.
There is a link because there are many reports and many conferences worldwide which… and very serious observations of the World Health Organization on the impact of poverty on poor health, on the health of the population. There is a link definitely between life expectancy and poverty.
Is there a risk, in a Union already divided between the eurozone 17 and the rest, to a division in terms of health standards? That it would be accepted that in some parts, health standards will be simply lower?
Not necessarily because it depends on the disease, but those diseases which are related to poverty like infectious diseases, related to poor and unhealthy diet, more consumption of alcohol and tobacco definitely, are more common for Eastern and Southern countries.
Since we are speaking about Bulgaria, next year there’ll be parliamentary elections. Do you yourself have plans for the elections? Are you going to run? What are your political ambitions?
My political party [National Movement for Stability and Progress NDSV] will definitely run in the elections next year. We have concluded a memorandum with one of the agricultural parties in Bulgaria [Zemedelski Naroden Sayuz, a party not represented in the current parliament] and we think that Bulgaria needs a smarter alternative of governance: More transparent, less populist, more responsible and more sustainable.
What we see in the country, it’s like we are trying to please the superficial supervision of the Commission for some budgetary requirements, but this is not the stability of the country. The true stability to me is the employment rate, it’s the number of young people which are employed, it’s the number of children that people are having. It’s also the literacy number, the number of people which have access to education and health care so also the stability of the industrial sector and mainly smaller and medium enterprises, many, many indicators.
Of course the level of corruption, the status quo of the judiciary system are always under consideration when we talk about Bulgaria, but I don’t see many successful policies in the country that have delivered to solve those problems. I should say that there is definitely a need for more proficiency in the state government.
So you say the country needs an alternative to the present government?
And a more professional government than this one.