The Polish reimbursement system will undergo significant reorganisation in 2017. Currently, two bills amending the Polish Act on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices appear to have important consequences for the pharmaceutical sector. These are: (i) the amendment bill of 21 September 2016, the so-called "major amendment"; and (ii) the amendment bill of 10 June 2016, designed to completely overhaul the reimbursement of medical devices, the so-called "medical devices amendment".
These bills are part of a wider initiative to improve the Polish reimbursement system with a number of new laws already in place, such as free access to medical treatment for patients over 75 years old.
The public consultations concerning the major amendment were completed on 24 November 2016. This is only the beginning of the legislative process and it will take some time before the proposed changes will come into force. However, this bill contains several key amendments worth noting in advance. Some of the proposed changes are radical, and there is uncertainty about how others will be implemented in practice.
On 25 July 2016, the public consultations relating to the medical devices amendment were completed. The version of 28 November 2016 taking into account some of the opinions expressed during the consultations was published on the Government Legislation Centre website1 on 1 December 2016. This update was also accompanied by Minister of Health's (MoH) proposal of a series of implementing acts. The amendment still needs to undergo legislative procedure at the Polish Parliament but the MoH has announced that it expects the medical devices amendment to come into force in mid-2017.
What does the "major amendment" mean for stakeholders?
- Possible modifications of reimbursement decisions by the Minister of Health ex officio
The bill allows the MoH to initiate proceedings to challenge reimbursement decisions ex officio. Under the bill, the MoH can challenge the conditions for reimbursement in the following situations: (i) reduced availability of the medical product covered by the reimbursement decision; (ii) increased costs for patients; or (iii) new circumstances regarding reimbursement criteria.
Under the new provisions, in the course of these proceedings, the MoH would be allowed to consult the Minister of Development, national consultants, and request from the President of the Agency for Health Technology Assessment and Tariff System (Polish: “AOTMiT”) preparation of the President's recommendation, an AOTMiT2 verification analysis, or an opinion of the Transparency Council of AOTMiT ("Transparency Council"). The MoH will also be entitled to summon the addressee of the relevant decision to negotiate any amendments to reimbursement decisions with the Economic Committee.
The MoH's new powers are unlikely to be welcomed by the pharmaceutical sector. This may also raise concerns amongst certain stakeholders as they might perceive it as a means of applying pressure on the reimbursement process.
The introduction of this mechanism may reduce business confidence, and challenge the principle in administrative proceedings that a final decision conferring specific rights cannot be changed or repealed without the addressee's consent.
- Obligation to apply a fixed margin for wholesale trade with foreign countries.
This proposed change is aimed at reducing the volume of exported drugs from Poland. Such exporting is based on the fact that prices for many reimbursed drugs in Poland are significantly lower than in the rest of Europe.
The question also arises as to whether the mechanism proposed by the MoH is in compliance with EU law, in particular the principle of freedom of movement of goods.
These issues will certainly be of particular interest to the Main Pharmaceutical Inspector (Polish: “GIF”), who regularly carries out inspections to ensure that businesses implement applicable laws properly.
- Other changes
Other significant changes under the major amendment concern, inter alia, changes to the penalties imposed for breaches of the obligation to ensure the size and continuity of drug supply; increases in the severity of administrative sanctions for failure to meet the obligations concerning RSS (Risk Sharing Schemes); and the introduction of specific regulations for vaccines and medicines used in ultra-rare diseases.
Big changes in medical devices reimbursement
The main aim of the medical devices amendment is to amend the reimbursement rules for medical devices to introduce a new reimbursement system modelled on drug reimbursement. The amendment will cover medical devices issued upon the order for supply3 and medical devices currently used in the framework of guaranteed benefits.
Although the new regulation could apply to all medical devices, the MoH will have the power to determine which group of medical devices will be covered by the new regulation. The MOH has already unofficially announced that the first refund will cover lenses, prostheses, stents and adult diapers.
Pursuant to the new provisions, a fee of PLN 10,500 (approx. EUR 2,300) will be charged when filing an application for reimbursement. The preparation of the AOTMiT verification analysis, recommendation from the President of AOTMiT, or an opinion of the Transparency Council4, will be subject to a fee of PLN 150,000 (approx. EUR 35,000).
Pursuant to the new provisions, the official sales prices for the medical devices will be established. Using prices other than those established in the reimbursement decision will be subject to a fine of up to PLN 10 million (approx. EUR 2.2 million).
What does this all mean?
It is difficult to determine what the proposed bills will mean for the pharmaceutical sector. The proposals under the major amendment could still change as a result of public consultations. The post-consultations report has not yet been published.
However, it is clear that the bills will force businesses to consider making significant changes to their activities, ranging from altering their distribution network to complete restructuring, or even the closure of business for small entrepreneurs from the medical devices sector who may not be able to meet the additional financial requirements under the new regulations.
Considering the changes to possible penalties, companies should now consider taking steps to adjust their business operations appropriately to comply with the new challenging provisions.