Challenges in the area of ​​science and health care

A key element of the healthcare system are hospitals, especially Institutes and Clinical Hospitals. They offer not only healthcare services to patients, but also make an important contribution to the development of medical knowledge and treatment methods. The strategic goal of the Minister of Health is to fully utilize the potential of the national hospital system. The imperfections of this system result from the lack of strategic and systemic solutions for the participation of Polish hospitals in the entire healthcare system, which includes not only disease prevention, diagnosis and treatment of patients, but also greater participation in the processes of developing new therapeutic methods.

Medicinal substances must undergo clinical trials in order to be approved for sale as drugs. Without the active and formal participation of hospitals and institutes, the implementation of such studies quickly, on a large scale and in accordance with the scientific methodology required to verify their safety and effectiveness is either not fully possible or is significantly limited. Limited at least by scale and time.

Particularly in the case of clinical trials requiring highly specialized procedures, their implementation outside the hospital requires the researcher and sponsor to agree to numerous compromises that reduce the quality of the research and affect the credibility of their results. Clinical trials are often carried out by researchers working in a given hospital, bypassing the formal contract processes involving the hospital on the terms of a full-fledged (and budget-sharing) participant. The exclusion of the hospital from the contracting process and formal participation in the study is often explained by bureaucracy (unfortunately, not without reason), and ethical and legal ambiguities are covered up by the alleged good of the patient. Such informal use of hospital support, i.e. non-contractual use of its infrastructure and resources, means that both the researcher and the study commissioners operate in a grey area of ​​financial settlements and legal and ethical dilemmas. Maintaining this state of affairs serves neither patients, nor the health system, nor hospitals. Nor, in the long run, to the researchers themselves.

Problems and ethically questionable situations that often arise in the case of “informal” implementation of a clinical trial by physician-researchers employed in hospitals include, among others:

• use of hospital equipment and infrastructure outside the health service system, for commercial research purposes,
• use of hospital staff resources for commercial research purposes during time paid for by the National Health Fund,
• dispersal of staff and researchers to perform tasks outside the scope of their duties during working hours, straining the already limited resources of hospitals,
• non-transparent financial settlements, if they are already implemented, between the parties to the research agreement, especially in the case where the researcher acts as the entity implementing the study (i.e. a clinical research center),
• administrative, procedural and technical difficulties, in the case where the researcher wants to formalize relations with the hospital under a contract for implementation of a clinical trial,
• medical, ethical and financial responsibility for the patient in the event of adverse events and the problem of the ability to respond quickly and effectively,
• legal and ethical concerns related to the use of hospital patient records to identify and recruit patients for clinical trials formally and sometimes also actually carried out outside the hospital.

A situation in which a researcher acts as a clinical trial center, without dedicated administrative and medical staff and technical infrastructure, creates additional inconveniences and risks related to the correct and timely documentation of the course of the trial, a long and often ineffective patient recruitment process, errors in the implementation of the protocol due to the informal implementation of research tasks “on the sidelines” of everyday work.

Pharmaceutical and biotechnology companies (i.e. sponsors of research) who insist in such a situation to continue the practice of treating the researcher as a clinical research center, act to their own detriment, limiting their own organizational efficiency, at the expense of implementing current tasks along the path of least resistance. They also become co-responsible for ethically questionable actions taken by researchers and expose the National Health Fund and indirectly taxpayers to losses.

How to reconcile all stakeholders of the health care system? Access to new and specialized drugs for patients requires their reimbursement by the National Health Fund, whichLast year it spent over PLN 11 billion on this purpose. It is in the interest of the sponsors of the study and political decision-makers and owners of medical entities to coordinate the processes of increasing the availability of drugs (especially in terms of reimbursement) and the clinical trial process, which – thanks to better management of financial resources – will allow for effective systemic support from hospitals.

Large public hospitals in Poland, especially clinical ones, can become effective participants in the clinical trial market in the country to the benefit of their own budget and all stakeholders, including primarily patients, researchers and staff, the State Budget and sponsors of clinical trials – pharmaceutical and biotechnology companies.

The most important benefits to be expected in the short term are:

• transparent and compliant with the scope of responsibility allocation of the budget to all entities carrying out the clinical trial, including the hospital, and other employees supporting the researcher, settlement of costs actually incurred by hospitals as a result of conducting a clinical trial on their premises, transparency in settlements, avoiding suspicions of unethical actions.
• settlement of costs actually incurred by hospitals as a result of conducting a clinical trial on their premises,
• transparency in settlements, avoiding suspicions of unethical actions.

The key elements of an efficient and modern health care system are:

• hospital and scientific institute institutions, with their own mission and technical infrastructure and resources human,
• doctors – and in the case of Institutes and clinical hospitals, those doctors who are both scientists and educators, whose task is, in addition to treatment, also to develop medical knowledge and implement new treatment methods,
• pharmaceutical and biotechnology companies that supply new medicinal substances and medical devices,
• state budget, taxpayers and, in the case of our country, the National Health Fund representing them.

These four aforementioned pillars of the health system are inextricably linked and doomed to symbiotic coexistence.

The participation of public hospitals and scientific institutes in this concept must change significantly compared to the current situation. It seems, however, that in the organizational sense, hospitals and institutes are still the weakest link in the system, unadapted in terms of administrative and budgetary procedures to take on a new role.

Fortunately, the case of the National Institute of Geriatrics, Rheumatology and Rehabilitation named after prof. dr hab. med. Eleonora Reicher in Warsaw shows the direction for effective solutions. Such a solution is the creation of a separate organization within the hospital, dedicated to acquiring, contracting, budgeting, administration and coordination of clinical trials in the hospital. Of course, it is not the name or the fact of establishing such an organization that is the solution to the problem, but the way it operates, resulting from the development strategy and budget policy of the hospital. The pillars of effective implementation of such a solution are:

• well-planned budget system and operational controlling,
• separation of medical tasks from administrative and financial tasks,
• coordination of the use of hospital resources,
• clear scope of duties of medical and administrative employees,
• specialist competences in the administration of clinical trial processes,
• clear rules and work discipline in the implementation of therapeutic and research tasks,
• clearly formulated and enforced principle of researchers refraining from implementing projects competing with those implemented by the hospital, as well as refraining from implementing “private” tasks that do not result from the scope of duties in a given position or from the employer’s order.

The benefits for all parties to cooperation on the new principles are clear and result to a large extent from the well-known in the economy of scale:

• for sponsors – more effective and faster recruitment, more randomized patients,
• for researchers – higher remuneration resulting from the division of duties into medical and budgetary and administrative, more randomized patients per studyacza,
• for co-workers, including other white staff – a significant share in the budget, in exchange for the implementation of tasks resulting from the allocation of duties, for the State Budget – weakening the pressure to increase financing in healthcare, more transparent and fair management of taxpayer money.
• for hospitals and research institutes – additional revenues remaining after covering costs, which can be used for investments or increasing patients’ access to healthcare services,
• for patients – significant increase in access to innovative therapies,
• for the State Budget – weakening the pressure to increase financing in healthcare, more transparent and fair management of taxpayer money.

Author:

Stanisław Pisarski,

CEO at Factor Consulting, Strategic Advisor