According to Peter Holchacker, director general of Hungary’s Association of Innovative Pharmaceutical Manufacturers (AIPM), “clinical trials initiated by multinational companies, represent, on average, an investment of approximately EUR 300 million each year.” Furthermore, Dr György Bodoky, founder and honorary president of the Hungarian Society of Clinical Oncology (MKOT), adds that clinical trials create “a great opportunity for patients to access new therapies and for doctors to gain hands-on experience. These trials offer Hungarian investigators both financial assistance and scientific prestige.”
[Clinical research] is a considerable economic investment for the country that is left untapped
State Secretary for Health Ildikó Horváth acknowledges that close interaction between the pharmaceutical industry and the authorities is of crucial importance in facilitating patients’ access to medicine, pointing out that “their innovations allow new drugs to reach 14,000 patients in clinical trials and the market early.”
Leveraging A Rich Clinical Environment
Hungary, in general, boasts a very innovative and well-organized infrastructure for clinical trials. The country’s involvement in clinical trials is outstanding within Europe: placing 10th in terms of the number of trials and 4th in terms of accessibility and availability of trials per capita. “Thanks to Hungary’s centralized healthcare, companies looking to conduct clinical trials here can find the right number of patients with good quality sites all while being supported by authorities,” asserts Dr Mátyás Szentiványi, director general of the National Institute of Pharmacy and Nutrition (OGYÉI).
Dr Zsuzsanna Fürst, president of the National Ethics Committee for Clinical Pharmacology (KFEB), elaborates that “the strengths of Hungary’s educational and medical institutional network, alongside the practitioners’ competency, makes the clinical pharma landscape in the country attractive for pharmaceutical companies.”
Unlike other nations, there is a specific occupation in Hungary of ‘clinical pharmacologist’. These professionals draft plans for pharmaceutical trials and create guidelines for prescribing medication. “Clinical pharmacologists have to be the head of the institution and/or principle investigator (PI) where the trials are conducted. This is very attractive for international clients,” Dr Fürst continues.
Irma Veberic, general manager of Roche’s local affiliate, for example, notes that Hungary is a strategic destination for the company’s clinical activity within Europe. “Not only does Roche employ over 1000 people in Hungary, we have a very strong clinical trial presence… In 2018, Roche involved many Hungarian patients in clinical trials across 150 sites. In total, we conducted 82 research studies across six therapeutic areas – the majority of our trials are in oncology,” she elaborates.
Veberic adds that Roche made payments totalling HUF 1946 (USD 6.5) million and generated a cost savings of HUF 6161 (USD 20.5) million for the Hungarian drug budget. “Our clinical trial program is one of, if not our strongest, program in Hungary and can create jobs and encourage Hungarian physicians to remain at home. We are very proud of this.”
Notably, the attractive local environment led to the company to select Hungary as the location for a new pharmacovigilance office – the PV HUB Budapest – in September 2019 that is responsible for 23 European countries and six countries from the Balkan Peninsula. “Our new offering here in Budapest will create 25 more highly skilled roles over the next three years and play a critical role in ensuring safety and wellbeing across Europe. The team will play a crucial role in capturing and analyzing data from our clinical trials and real-world use of our medicines,” she adds.
Rough Seas Ahead for Competitiveness
Over the past decade, clinical trial numbers in Hungary have been relatively stable, ranging between 320 and 390 new trials conducted every year. However, regional and international competition to attract trials remains very high and the number of amendments made to the registration process has been increasing yearly, which is related to the growing complexity of components that are being assessed by authorities
Trial applications pass through the National Competent Authority (NCA) and then are forwarded to the KFEB. Once submitted, there is a 60-day deadline for the evaluation process to take place – 30 days for initial applications and another 30 days for amendments. This timeframe also includes the time the sponsor needs to answer the deficiencies. However, the NCA has 15 more days for their decision to be taken.
This lengthy process is increasingly a sore point for pharma firms who bemoan a loss of competitiveness in the overall Hungarian clinical trial environment. Furthermore, many pharma players feel that a lack of financial incentives reflects the authorities’ lack of recognition of the significance of these investments. Holchacker claims that “the current Hungarian administration is making serious efforts to provide business opportunities for newcomers by supporting them with favourable financial and regulatory policies. However, some of these incentives are focusing on regular business and investments. This [clinical research] is a considerable economic investment for the country that is being left untapped.”
Dr Fürst agrees, noting that “there is only a limited amount of funding available in the country. Many hospitals, university clinics, small and unknown organization scramble for the finances and medical equipment necessary to conduct their trials.”
With the tremendous competition between the European, Central Eastern, and Asian countries in this domain, if Hungary wants to continue to remain competitive, “the regulatory framework needs preparation and maturing…The needs and requirements encompassing clinical trials are increasingly demanding, and a new European policy implementation is not enough to improve the attractiveness of the country,” asserts Holchaker.