Alexandru Rafila: “Access to generic drugs is a priority”. What are the plans of the Ministry of Health

The Minister of Health, Alexandru Rafila, emphasizes the priority of access to generic drugs, including oncology, and supports the Romanian pharmaceutical industry. Health ministry plans include implementing disease registries for more predictable health policies and expanding the list of compensated and free drugs.

Access to generic medicines, essential for health – Photo Archive

I think that in this discussion about generics and original medicines it is not about a competition normally, it must be about a fair access of patients to medication, because we cannot deprive the vast majority of patients in a country of generic drugs that are affordable in the first place, cover the whole range of therapeutic areas, including oncology because many of the oncology drugs are generic drugs and this must be very clear – access to generic drugs is a priority and for the Ministry of Health and in general for politics within the European Union“, said the minister at the conference “Sustainability and predictability of the health system. The role of generic and biosimilar medicines” organized by the Romanian Generic Medicine Manufacturers Association, according to Agerpres.

Supporting the Romanian pharmaceutical industry is a crucial component, says the minister.

There is another component related to supporting the Romanian pharmaceutical industry. It takes place in the present moment. They are important companies from Romania. The Romanian state is the majority shareholder in only one, Antibiotice Iaşi, but there and in other companies that are exclusively private capital there is an interest in this industry being supported, because on the one hand it brings resources of an economic nature and on the other on the other hand, it also offers access to medicines that have reasonable prices and cover all therapeutic areas”Alexandru Rafila pointed out.

Moreover, in the coming period, disease registries will appear that will help the authorities in planning health policies.

In the next period we will start having in Romania as well disease registers. Disease registries make health policies and the need for financing predictable because we know exactly how many patients we are talking about, and those cost-volume-result contracts have behind them data that is real and not estimated. And from the point of view of the Ministry of Finance, if it knows exactly how much it has to finance in a year, for example, original medicines, then the budget adaptability is better“, explained the Minister of Health.

At the same time, Alexandru Rafila reminded that the list of compensated and free medicines was recently expanded, through an Emergency Decision, with 28 innovative treatments.

There is regulation in terms of access to biosimilar medication, so that it becomes the majority for these biological drugs, as we call them, but surely there are two elements here that need to be taken into account: it is about how doctors prescribe these drugs and how they accept patients, how they talk to patients. Consider that there are treatments that some people have been taking for years and the moment you change their medication, even if it's a biosimilar, there is some reluctance on the part of patients. These things last. We made the legislation that allows access to biosimilar medication, but it is a process that I believe will slowly lead to better access to medication for those with conditions that require biological treatments”claimed Rafila.

Non-discriminatory access to medicines, essential for the health system

For her part, Carmen Orban, State Counselor in the Prime Minister's Chancellery, emphasizes the importance of ensuring non-discriminatory access to a wide range of medicines, including generics, biosimilars, innovative medicines and new therapies.

“It is extremely important to have non-discriminatory access both to generic and biosimilar medicines, as well as to innovative medicines and new therapies. There are diseases in which without these innovative medicines you cannot overcome the disease stage and then each type or class of medicine has its role The role of generics and biosimilars is essential, because they are the basis of any hospital's medication. ..) Some shortcomings related to prices for generic and biosimilar drugs have been resolved“, said Orban, during the same event.

However, the doctor adds that there are persistent challenges in ensuring access to the basic substances needed for the production of medicines.

The COVID pandemic and the geopolitical situation of our country show that we have some problems and gave us some warning signs. There are many factories in our country … but the problems both at the country level and at the European level remain the same. Access to the basic substance is still extremely difficult. We are talking about very distant countries – India or China – which make it very difficult to supply these factories. Not long ago, our country was an important producer of raw materials, and I think that somewhere here, the governors should concern themselves with finding new solutions and returning our country to the level it was at not long ago. (…) It would greatly help not only Romania, but also European countries for the possibility of manufacturing many generic or biosimilar medicines“, believes Carmen Orban.