News

SFEE’s EXTRAORDINARY GENERAL ASSEMBLY
Athens, December 16th, 2019

Subject: «SfEE position on handling the clawback from 2020 to 2023»

CURRENT SITUATION

The EOPYY clawback course for 2019 is uncontrolled and beyond any Greek or European precedent, increased by 40% vis-à-vis last year.

This increase is attributed to:

a) Legal provisions that:

• encourage the unjustified prescribing (i.e. prescribing for the uninsured by private doctors)
• provide across the board alleviations to social groups, as part of a social policy exercise, with no provision for increased spending (e.g. uncontrolled AMKA allocation, reduced or no participation in insured groups) and
• cause additional expenditure due to distortions in the reimbursement policy (e.g. equating reimbursement price of generics with their retail price, reducing patient contribution in drugs under negotiation).

b) Lack of effective e-prescribing control and other control mechanisms.
c) Serious delay in the negotiation procedure.
d) Significant increase (+25%) of the vaccine expenditure, due to the extensive vaccination campaign of the population, mainly implemented by the state.

The direct consequence of all the above, combined with the chronic insufficient funding, is an unprecedented burdening of the pharmaceutical industry, caused by the mandatory returns which directly affect the sustainability of pharmaceutical companies and the availability, primarily, of cheaper medicines, while making the launching of new medicines in the domestic market practically impossible, creating potentially negative consequences on patients’ quality of care.

MINISTRY OF HEALTH PROPOSAL

The Ministry, instead of adopting measures to control the undue excess, proposes the re-allocation of this excessive expenditure on the rationale of 75/25, whereas in the composition of the latter, the 25%, all generics and off-patent drugs are excluded, on the premise that these drugs bring about savings while the on-patent ones cause an expenditure increase.

Α. SFEE POSITION

SFEE

Does not agree with the logic of product category exemptions and rejects the Ministry’s proposal in Principle, as the main problem with clawback is not its allocation but its excessive size.

Furthermore, through this Ministry proposal:

• Development is punished – development being the main constituent element of entrepreneurship.
• The entry of new medicines and any investment prospect and intention are discouraged.
• Alleviations on medicines are wrongly related on the basis of whether they are protected by patent or not, on the premise that only on-patent drugs are responsible for the expenditure increase. There is no country in Europe granting across the board alleviations to reference medicines.
• Legal issues are raised regarding the products that are considered on- or off-patent (regardless of whether they have a generic or not), the biological off-patent products and the bio-similar ones.

Β. SfEE PROPOSAL

1. FOR THE YEAR 2020

SfEE sets as immediate priorities, with a view to reducing clawback in 2020, the following:

• Increase of the public pharmaceutical expenditure budget.
• Separate, additional, budgets for the uninsured and the vaccines.
• Drastic imposition of control measures against uncalled-for prescribing.
• Cap-setting on clawback and co-responsibility with the State.
• Speed up the work of the Negotiating Committee.
• Participation of the rest of the supply chain in the clawback – calculating the clawback at the ex-factory prices.
• Reviewing the Positive List and transferring some categories to the Negative List.
• Increase of the Hospital expenditure budget, since the mandatory clawback and rebates have reached a level equal to state expenditure.
• No adoption of legislation with retroactive effect.

   2. FOR THE PERIOD 2021-2023

Immediate creation of a Working group consisting of members from the State and the Pharmaceutical Industry, with a view to drafting and presenting proposals for the signing of a three-year Memorandum of Understanding (MoU) for the period 2021-2023, as is the case in most European countries, in order to restore and ensure smoothness and predictability in the business environment and, most importantly, safeguard public health.