On 30 June 2021, a draft bill amending the Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs for Special Nutritional Purposes and Medical Devices (the “Reimbursement Act”) and certain other acts was published (the “Draft bill”). The Draft bill includes a comprehensive review of the reimbursement legislation and aims to implement solutions to improve it by solving practical issues that have become apparent in recent years. Among other things, it aims to increase the manufacturing of medicines and active substances in Poland. The Draft bill is subject to public consultation until 30 July 2021.

The Draft bill includes the following:

1. Introduction of "reimbursement secrecy"

Reimbursement secrecy introduced in the Draft bill means the non-disclosure of documentation on the risk-sharing scheme (RSS) and during proceedings before the Economic Commission, collected throughout the reimbursement proceedings, and information related to the official selling price (its increase, decrease, establishment or change) or reduction of the duration of the reimbursement decision. To date, this information has been treated as a trade secret, but without an explicit provision in the Reimbursement Act - which has now been added in the Draft bill.

2. Benefits for companies manufacturing medicines and active substances in Poland

The Draft bill provides for preferential reimbursement conditions for companies that manufacture medicines and active substances in Poland. These can include:

• an exemption from the payback mechanism (i.e. the return of the exceeded reimbursement amount) – this cost will be borne by the National Health Fund (“NFZ”);
• the issuance of the first reimbursement decision for three years and each subsequent reimbursement decision for five years under certain conditions;
• an exemption from price negotiations with the Economic Commission – in the case of applications continuing the reimbursement of a medicine;
• the examination of the application within no more than 90 days or 120 days – depending on the category of reimbursement availability;
• the reduction of the application fee or supplementary application fee and the reduction by up to 50% of the fee for the analysis by the Agency for Health Technology Assessment and Tariff System;
• the reduction of the patient's co-payment for the medicine – by 10% if the medicine or its active substance is manufactured in Poland, and by 15% if the medicine is manufactured in Poland using an active substance manufactured in Poland;
• setting the official sales price at 75% of the official sales price of the only reimbursed equivalent in a given indication;
• setting the official sales price of a medicine manufactured in Poland or manufactured using an active substance manufactured in Poland at an amount exceeding 150% of the basis for the funding limit, provided that in a given limit group the share of medicines manufactured in Poland does not exceed 50% of the volume turnover realised in that limit group.

3. Total reimbursement budget

The total reimbursement budget will continue to amount to no more than 17% of the sum of public funds allocated for the financing of guaranteed services in the NFZ’s financial plan. The budget will include funds from the RSS and payback.

Currently, the Minister of Health issues a regulation indicating the way of distributing the financial resources which constitute an increase in the total budget for reimbursement in the previous year. The Draft bill repeals this and allows the NFZ to distribute the received funds immediately, without waiting for the Minister of Health to update the regulation.

4. Change of the payback mechanism

Currently, an overrun of the reimbursement budget is considered on an annual basis. Entities whose reimbursement decision includes RSS do not participate.

The Draft bill suggests that in the case of the launch of payback, only a small group of entities will be exempt from participating in the mechanism. Payback is to be settled quarterly.

5. Strengthening the role of the Economic Commission

Reimbursement negotiations are to take place primarily before the Economic Commission. There is a ban on modification of the reimbursement application after the adoption of the resolution by the Economic Commission. Only in justified cases may the Minister of Health conduct additional negotiations with the applicant after the adoption of the resolution by the Economic Commission - if they are deemed necessary due to the unmet needs of beneficiaries and the payment capacity of the entity obliged to finance services from public funds.

6. Increase of the QALY threshold

The Draft bill assumes doubling the current threshold of the cost of obtaining an additional quality-adjusted life year (QALY), from three to six times GDP per capita.

It will be obligatory to refuse the reimbursement of a medicine or a foodstuff for special nutritional use if the threshold of the cost of obtaining an additional quality-adjusted life year exceeds six times the GDP per capita (or the cost of obtaining an additional year of life, if the cost of and additional QALY is impossible to determine).

7. The validity of decisions containing risk-sharing schemes

The validity of a decision containing a RSS, in the part concerning the RSS, will be extended. Such a decision will expire, in the part concerning the RSS, after a period of "up to 10 years" from the date of its issuance. Generally, reimbursement decisions are issued for two or three years, so the extension of the validity of a RSS would allow the effectiveness of the therapy to be measured after a longer period of time, and to create the RSS accordingly.

Considering the above, the reimbursement system in Poland may undergo major changes in the near future. However, as it is at an early stage, the Draft bill may still be subject to various modifications.