​Romania is one of the last places in Europe in terms of access to the most modern medicines: a new drug reaches patients the fastest in Germany – in 128 days, compared to 918 days in Romania. The European average is 517 days from the moment of obtaining a sales license.

“We have many patients who have left the country, trying to build a life in another place, to have access to therapy”

“We have many patients who have left the country trying to build a life elsewhere precisely to get access to therapy that they didn’t have access to in Romania,” says Rosalina Lapedatu, president of the Association of Patients with Autoimmune Diseases.

“There is another option, when patients buy their medicines in Germany and other countries and inject them in Romania or have family and friends who buy them from there, but at a very high price – we are talking about medicines, the cost of which is very high. , from 5,000 lei and above. And 5,000 is not enough, I was undergoing treatment for a rare disease, which costs 350,000 euros per year,” adds Rosalina Lapedatu.

The fastest new drug arrives in Germany – in 128 days, and the latest – in Malta – in 1350 days.

Romania is at the bottom of the European rankings for both the level of availability of medicines and the time for patients to access the most advanced treatments, according to a series of reports on the availability of new medicines across Europe, published by the European Federation of Pharmaceutical Industries and Associations, an organization that also includes the Romanian Association of International drug manufacturers. The EFPIA Patient Waiting Indicator 2022 tracks the availability of new medicines and the length of time it takes for patients to access them in 37 European countries.

The figures show that, on average, a new drug reaches patients in Germany at 128 days, compared with 918 days in Romania and 1,351 days in Malta, and the European average is 517 days.

In Europe, the average level of availability of medicines across all therapeutic areas fell to 47%, which is 2 percentage points less than last year. Differences persist between Northern and Western Europe compared to Southern and Eastern Europe, with an average difference in affordability of 80%.

Modern medicines in Romania:

• out of 168 innovative medicines that received a centralized marketing authorization in the period 2018-2021, as of January 5, 2023, only 51 medicines were available in Romania, i.e. an availability level of 30.

• the time from centralized marketing approval to appearance in Romania is 918 days, i.e. more than 2 and a half years, while Germans have access to state-of-the-art drugs in 128 days, Italians in 436, Hungarians in 549, and Bulgarians in 705 days. The access time increased compared to similar data from the WAIT 2021 study, which indicated a waiting time of 899 days for Romanian patients.

• in the case of oncology drugs, only 14 of the 46 approved for sale during this period were available to Romanian patients, and only half of them are in full availability mode. Access time is even longer for oncology drugs, reaching 991 days for Romanian patients.

• for orphan drugs, the availability rate was 34% (21 out of 61), and the access time was 909 days.

The data were presented in the context of the publication on April 26, 2023 of the draft amendments to the EU pharmaceutical legislation. The revision of pharmaceutical legislation is a unique opportunity for Europe and European patients, including from Romania.

What are the main reasons delaying Romanian patients’ access to the most modern medicines

The main reasons leading to delays are primarily related to the insufficient predictability of the legislative scheme for updating the list of compensated drugs and publishing the corresponding therapeutic protocols. Other factors affecting access time include health technology assessment criteria, as well as delays due to cost contract negotiations for drugs with a conditional inclusion decision.

The main solution would be to update the list of reimbursed medicines 3-4 times a year, including all medicines that have received an inclusion report from the National Agency for Medicines and Medical Devices of Romania (ANMDMR).

“Unfortunately, Romania has reached an alarming negative record: we have exceeded the 900-day threshold for patients’ access to the most modern medicines. We appreciate the efforts of the authorities in recent years, which have decided to reimburse some important medicines. It is necessary to continue the partnership and constantly strive to improve these statistics. ARPIM member companies have undertaken an important mission, namely to submit files for price approval and reimbursement as soon as possible, but from this moment on, the authorities are obliged to complete the process as soon as possible”, – states Cecilia Radu, President of ARPIM.

“Looking at the directions and priorities and goals that the new proposals outline at the European level, we could also change certain legislative acts, both primary legislation, laws and implementing legislation. Many things that we can improve to reduce the time for patients to access innovative treatments are related to either better organization of some institutions in Romania or some changes at the ministerial level. These are the two plans I see coming forward in the near future. First of all, let’s be proactive, participate, put forward ideas and concrete proposals to modify European legislation, and then make an action plan with what we need to change in Romania, first of all to adapt to our European goals, second , reduce some administrative barriers at the national level. It is important for Romania to understand this European direction, to adapt in parallel, and not necessarily to wait for the completion of this legislation, and this is the main message that I am addressing to the Ministry of Health, the Government of Romania and my colleagues in the Parliament, to be proactive, to participate with proposals , let’s predict what the final result will be, and let’s start preparing the Romanian legislation now,” says Christian Bushoi, Member of the European Parliament.

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