Business calls for increased transparency in the managed entry agreement process

02/ 10/ 2024

In August 2024, the Ministry of Health of Ukraine (MoH) published a draft Resolution of the Cabinet of Ministers of Ukraine, proposing amendments to the current regulations governing the process of entering into managed entry agreements (MEA). A managed entry agreement is a mechanism for procuring innovative medicines based on negotiations between the central executive authority responsible for healthcare policy (in Ukraine, the MoH) and the pharmaceutical manufacturer. This is a common global practice successfully used in developed countries. The Health Сare Committee of the European Business Association welcomes the initiative of the state authorities to improve the MEA process. At the same time, according to the Committees experts, the current version of the document introduces discriminatory approaches towards drug manufacturers during negotiations. This may lead to excessive price pressure at the invitation stage and, as a result, manufacturers may decline invitations or refuse to enter into agreements in the future. Ukrainian patients, in particular, may suffer the consequences, as their access to free innovative medicines could be at risk. It is worth noting that an important step leading to the conclusion of an MEA is health technology assessment (HTA). Currently, the HTA system is still being developed in Ukraine and undoubtedly requires further improvement at the legislative level. An important component of this system, technology appraisal, which involves clinical and economic evaluations, has not yet been introduced in Ukraine. Without using the mechanism provided by this procedure, prioritizing solely based on cost-effectiveness ratios relative to GDP is not considered fair by the ЕВА’s experts, as the clinical benefit of a given technology is not taken into account. Consequently, the long-term impact on patients and the economy is not considered. It should be noted that there have been recent steps in the development of the HTA system in Ukraine. For example, an Expert Committee was recently established within the State Expert Center. However, it is important to ensure that the selection of experts for such a committee is based on criteria that include competencies and experience in health technology assessment. Another issue that requires further regulation is the uncertainty regarding the start and duration of negotiations. Currently, the timeline from receiving the HTA conclusion to the start of preparation and negotiations is not defined, and the duration of the negotiations varies significantly from agreement to agreement. This uncertainty complicates planning for pharmaceutical manufacturers, which may result in delays in medicine supply. Given these concerns, the ЕВАs Committee has prepared detailed proposals for the draft Resolution and submitted them to the MoH. The business community’s suggested changes aim to address existing shortcomings and optimize the MEA process. The ЕВАs experts hope for the authorities attention to the proposals, as the implementation of these changes would create an effective and transparent MEA system for both parties, promote equal opportunities, eliminate illegal discrimination, and ensure patient access to innovative medicines.

A managed entry agreement is a mechanism for procuring innovative medicines based on negotiations between the central executive authority responsible for healthcare policy (in Ukraine, the MoH) and the pharmaceutical manufacturer. This is a common global practice successfully used in developed countries.

The Health Сare Committee of the European Business Association welcomes the initiative of the state authorities to improve the MEA process. At the same time, according to the Committee’s experts, the current version of the document introduces discriminatory approaches towards drug manufacturers during negotiations. This may lead to excessive price pressure at the invitation stage and, as a result, manufacturers may decline invitations or refuse to enter into agreements in the future. Ukrainian patients, in particular, may suffer the consequences, as their access to free innovative medicines could be at risk.

It is worth noting that an important step leading to the conclusion of an MEA is health technology assessment (HTA). Currently, the HTA system is still being developed in Ukraine and undoubtedly requires further improvement at the legislative level. An important component of this system, “technology appraisal,” which involves clinical and economic evaluations, has not yet been introduced in Ukraine. Without using the mechanism provided by this procedure, prioritizing solely based on cost-effectiveness ratios relative to GDP is not considered fair by the ЕВА’s experts, as the clinical benefit of a given technology is not taken into account. Consequently, the long-term impact on patients and the economy is not considered.

It should be noted that there have been recent steps in the development of the HTA system in Ukraine. For example, an Expert Committee was recently established within the State Expert Center. However, it is important to ensure that the selection of experts for such a committee is based on criteria that include competencies and experience in health technology assessment.

Another issue that requires further regulation is the uncertainty regarding the start and duration of negotiations. Currently, the timeline from receiving the HTA conclusion to the start of preparation and negotiations is not defined, and the duration of the negotiations varies significantly from agreement to agreement. This uncertainty complicates planning for pharmaceutical manufacturers, which may result in delays in medicine supply.

Given these concerns, the ЕВА’s Committee has prepared detailed proposals for the draft Resolution and submitted them to the MoH. The business community’s suggested changes aim to address existing shortcomings and optimize the MEA process. The ЕВА’s experts hope for the authorities’ attention to the proposals, as the implementation of these changes would create an effective and transparent MEA system for both parties, promote equal opportunities, eliminate illegal discrimination, and ensure patient access to innovative medicines.