The potential of the innovative pharmaceutical industry in the Czech Republic has not been sufficiently saturated. For instance, there are no adequate regulatory requirements and necessary investments in science and research. We are thus faced with limits that hinder higher economic efficiency, a timely entry of medicinal products and further development of the segment that has a major impact on the health of the population and the national economy of the Czech Republic.
DEVELOPMENT POTENTIAL
The potential of the innovative pharmaceutical industry has not been saturated in the Czech Republic. For instance, there are no necessary investments in science and research. Overall direct investments in pharmaceutical research and development (based on NACE classification) are relatively low compared to other V4 countries. Direct investment in pharmaceutical research and development represents 2.38% of total R&D expenditure in the Czech Republic, while in Poland it is 7.29%, in Hungary 13.33% and in Switzerland even 31.45%. The development of health care, including innovative pharmaceutical products, brings savings in all other care segments.
This situation is a result of relatively complicated market regulation. The procedure for allowing innovative medicinal products to enter the Czech market is long and in most cases the decision is not made within the statutory time-limit, which significantly reduces the availability of innovative medicinal products on the Czech market. Less than 40% of entries of medicinal products on the Czech market were decided on in a timely manner.
“The system must adapt to the new type of medicinal products that are entering it. Nowadays, we approve them ad hoc, which is contrary to how the system in our country is set up. The system claims that patients should have the same chance and the same accessibility yet is unable to correctly assess and decide on the entry of new types of personalized therapies,” says Mgr. Jakub Dvořáček, MHA, executive director of the Association of Innovative Pharmaceutical Industry (AIFP).
The Czech Republic is also lagging behind in terms of the number of new clinical trials. Between 2015 and 2017, the number of new clinical trials dropped from 81 to 67. The Czech Republic has not been exploiting the entire potential of the existing science and research infrastructure.
More complex mathematics are coming
The overall strategy of the healthcare system development should include both prevention and innovative methods and medicinal products. To improve patients’ lives, it is essential to ensure that all patients have access to innovative treatment and medicinal products, to speed up the procedures for their approval and reimbursement and to change the method of financing expensive treatment.
“We need to adapt the system and get ready for more complex mathematics, a completely different way of financing and different types of contracts. The flexibility of the pharmaceutical industry and payers will play a major role. We have to set up mechanisms ensuring that neither party runs too much risk,” explains Jakub Dvořáček.
Is there a light at the end of the tunnel?
The timely marketing of innovative medicinal products is hindered in particular by the legislative framework. Nevertheless, the regulatory environment has begun to change recently. The Ministry of Health of the Czech Republic plans to amend the Public Health Insurance Act. This amendment should speed up and facilitate the assessment of medicinal products upon their entry into the system. Administrative proceedings of the State Institute for Drug Control should also be simplified and new rules for the assessment of orphan drugs and so-called highly innovative medicinal products should be set up.
An amendment to Act No. 72/2000 of Coll., on investment incentives and amendments to certain acts, was adopted and came into effect on 6 September 2019. The goal of the amendment is to provide incentives for high added-value facilities and technological and strategic service centers. This should help to move the labor force from production to highly skilled jobs in science and research.
In February 2019, the new innovation strategy "Czech Republic: The Country for the Future" was approved. This strategy recommends priorities that should place the Czech Republic among Europe's leaders by 2030. In April 2019, the Ministry of Health, in cooperation with AIFP and hospital representatives, issued a methodological recommendation concerning the content of the agreement on clinical trials of medicinal products for human use. This agreement is expected to speed up the approval process from one year to several weeks.
Cooperation in research and development
In addition to defining a suitable regulatory environment for R&D investments, it is important to support the exploitation of current R&D facilities, particularly the exploitation and development of people. The quality of the research infrastructure in the Czech Republic keeps improving with financial support from the private sector, state funds and EU funds. The number of R&D workplaces is also increasing. The creation of four European Centers of Excellence in the Czech Republic has been financed from EU funds since 2010.
“Collaboration between scientific and research institutions and the innovative pharmaceutical industry is an important opportunity and driver of change for the innovative sector. All stakeholders should make use of it and support change,” concludes Jakub Dvořáček.
