INFARMA Criticizes Changes to the Reimbursement Act

INFARMA, the Association of Innovative Pharmaceutical Companies, has published a statement regarding the draft amendment to the Act on the Reimbursement of Medicines, Foods for Special Nutritional Uses, and Medical Devices.

According to INFARMA, these are not technical changes, but rather measures that could significantly impact the functioning of the entire reimbursement system. “The scale and nature of these changes show that they are not technical adjustments, but proposals of fundamental importance to all participants in the reimbursement system in Poland,” the statement reads. The organization points out that such important regulations should be subject to broad consultations and preceded by a thorough regulatory impact assessment.

Is the refund just a formality?

One of INFARMA’s main concerns is the risk of creating a situation in which a drug remains formally reimbursed, but its actual availability to patients is limited, as the introduction of additional mechanisms favoring selected drug technologies could lead to a situation where a patient is told that a treatment is reimbursed, yet in practice will be unable to access it. “The reimbursement system should ensure that patients have actual, not merely formal, access to publicly funded treatment,” INFARMA emphasizes.

The doctor should decide on the treatment

Further concerns relate to the impact of the proposed regulations on physicians’ clinical decisions. INFARMA points out that treatment under drug programs requires an individualized assessment of each patient, taking into account the course of the disease, prior therapies, contraindications, and treatment tolerance. According to the organization, administratively restricting treatment options runs counter to the direction of modern medicine. “Modern medicine is moving toward personalized treatment, not toward automatically assigning patients to a single, administratively designated option.”

INFARMA notes that physicians will continue to bear professional responsibility for the treatment of patients, despite the limited options for therapy.

Concerns about competition and security of supply

The association emphasizes that it supports the prudent management of public funds and price competition, but opposes measures that could lead to the administrative elimination of reimbursed innovative drugs. According to the authors of the position paper, such regulations could restrict competition in hospital procurement procedures, increase the risk of market monopolization, and, as a result, also undermine the security of the drug supply.

Changes to Individual Reimbursement

Proposals regarding individual reimbursement for medications imported from abroad were also met with criticism. INFARMA points out that the new measures could force patients to choose between starting treatment immediately and the possibility of obtaining reimbursement.

– Patients should not be forced to choose between starting treatment immediately and losing the opportunity to apply for reimbursement, or waiting for administrative decisions and risking a deterioration in their health.

Concerns regarding EU law

The statement also raised concerns regarding the compliance of the proposed measures with European Union law. According to the organization, the proposed mechanisms may raise concerns regarding transparency, proportionality, non-discrimination, and the free movement of goods within the single market.

INFARMA believes that the draft requires a thorough analysis to ensure its compliance with EU law, and that some of the provisions may need to be notified to the relevant EU institutions.

Call for Further Consultations

The organization emphasizes that it does not oppose the rationalization of public spending on drug reimbursement; however, in its view, changes should be developed through dialogue with all stakeholders in the healthcare system.

– INFARMA calls for a re-evaluation of the provisions added after the public consultation period ended. Such significant changes should be assessed in terms of their impact on patients, physicians, hospitals, the public payer, market competition, and compliance with European Union law.

Source: Press release