General
Regarding the amendments to the omnibus bill (L. 4512/2018) in the health sector, the following are identified:
1. Evaluation Committee
The most important regulation which is scientifically-technically supported and “stamped” by the World Health Organization is the creation of the HTA Committee, which shall serve as an evaluation mechanism of new medicines, based both on financial and scientific criteria, emphasizing less on the cost of the pharmaceutical innovation and more on their therapeutic value as well as on the documentation of the benefits for the patient. Greece, being one of the few countries without an HTA Committee, now acquires for the first time, through the provisions of L. 4512/2018, an evaluation procedure of medicines which is based on a multi-criteria analysis of each medicine’s given information: unmet medical need, therapeutic benefit, comparison to different treatments, reliability of clinical studies, cost-effectiveness, and impact on pharmaceutical expenditure.
More specifically, according to article 247 of this Law, the work of the Evaluation Committee is the issuance of an opinion addressed to the Minister of Health, following the medicines’ evaluation, which received a marketing authorization and is marketed in Greece, before adopting a decision in relation to:
a) The inclusion or exclusion of the medicines from the Positive List of article 12 of L. 3816/2010 (A’ 6) (List of Reimbursed Medicines) and
b) The revision of the List of Indemnified Medicines of the above article.”
However, a key element of thought regarding the provision’s effectiveness is the following paragraph which states that: “The Minister of Health may decide differently from the Evaluation Committee’s opinion, with a specific justification, which is based on article’s 249 criteria.”
The Evaluation process
More specifically, for the evaluation of a medicine by the Evaluation Committee and for its inclusion in the positive list, the Marketing Authorization Holder (MAH) shall:
a) Submit to the Evaluation Committee a relevant application, accompanied by a complete file comprised of the relevant information and documentation and
b) Pay on a one-off basis the evaluation fee, which is to be determined through a mutual decision by both the Minister of Finance and the Minister of Health.
A key element of the pharmaceutical products’ evaluation process is the prediction that:
2. For the assessment of the effects on the budget caused by a medicine’s inclusion in the List of Reimbursed Medicines, the Evaluation Committee necessarily refers all applications, which have initially received a positive evaluation based on criteria a’ to c’ of the previous article’s paragraph 1, to article’s 254 Negotiation Committee.”
The Negotiation Committee established by article 254 of the same Law, commences and completes the medicine’s negotiation process and issues a reasonable opinion, based on the negotiation process’ result regarding the effects caused on the budget by including or maintaining a product in the Positive List.
Finally, according to this procedure, in case of a decision rejecting the inclusion of a medicine in the Positive List, the MAH may submit a new application under two conditions:
A) After the expiry of a period of six months since the issuance of the above decision, and
B) If he also submits information and clinical and economical documentation which justify a new essential evaluation of the product based on the criteria of health technology assessment.
The aforementioned evaluation process must be completed within two years as of the issuance of the above decision. The above evaluation process must be launched every three years since the completion of the previous evaluation and must be finalized within one (1) year, with reference to all medicines which are at the stage of their data protection, are included in the Positive List and are therapeutically equivalent to the medicines for which an application for inclusion has been submitted.
2. Price Negotiation Committee
The Negotiation Committee, which has already been working towards minimizing the cost of expensive medicines, has as a main responsibility the price and discount negotiation for the products that are reimbursed by EOPYY or are procured to the public hospitals. The agreement between the two parties, the MAHs and EOPYY, is obligatory.
3. Negotiation Committee for Medical Devices
Through article 255 of the new Law, the old provision of Law 3918/2011 is standardized and is now endorsed by the Hellenic Ministry of Environment and Waters. The Negotiation Committee for Medical Devices and Prices shall negotiate with all contractors, in relation to their fees, the contractual terms and the prices of medical devices, as well as propose to the Board of Directors of EOPYYY whether to maintain or modify all of the above. No compensation is paid to the members of the Committee which from now on has no competence on Medicines.
4. Abolishment of the Medicinal Product Prices Committee
Article 17 (1), (2) and (3) of the Decree no. 96/1973 (A'172) is replaced by the provision of Article 259, thereby abolishing the Medicinal Product Prices Committee, with the result that 'Maximum retail, wholesale, hospital, ex-factory and the prices of any other special sale of medicines other than Non-Prescription Medicines are determined by a Price List issued by the Minister of Health following an opinion of the National Organization for Medicines.
5. Electronic Pre-approval System
In accordance with the text of the new law, and in particular Article 265 thereof, a single Electronic Pre-approval System (EEP) is created, through which an electronic management and examination procedure is established in order to assess any claims for the necessity of reimbursement of medicines for which a decision is taken by EOPYYY for some, more sensitive patient groups to have easier access to their treatment.
In particular, requests submitted to EEP should relate to:
(a) High-cost medicines for specific conditions
(b) Medicines that are not available in Greece and may be obtained only through extraordinary imports or individual requests.
(c) Off-label use of medicines
(d) Medicines that are not included in the Positive List and are requested to be granted exceptionally for diseases or pathologies directly threatening to life or capable of causing irreparable damage to health.
(e) Early access medicines not provided by the MAH or the local representative free of charge and for which a temporary individual authorization is requested by the ΕΟF;
6. Other Provisions
Τhe State’s amplified control of the transplantation process from an "emotional" donor is minimized while, at the same time transplants with financial or other incentives are also avoided in order to ensure the active and constant consent of citizens for the donation of organs and hence the increase in the available transplants, with the establishment of the “donor card” of National Translation Organization.
Article 262 of the new law further provides for the possibility of requesting the legalization of the Public Medical Assistance Reproduction Units until the completion of the envisaged licensing procedure, based on the specifications of Presidential Decree 10/2016.
The new provisions also seek to regulate the already existing liberalization of pharmacies' hours by introducing mandatory minimum working hours for all pharmacies, compulsory participation of 'extended' pharmacies in on-call duty, mandatory declaration of extended hours, closed pharmacies on Sundays, a ban on "seasonal" pharmacies and a ban on the use of "misleading" symbols or terms (green cross) from non-pharmacies.
Finally, new detailed rules regulate the operation, purpose and responsibilities of the Pan-Hellenic Medical Association, which appears to be more actively involved in informing the state about medical issues and transposing international standards in the country.
Contact
For any further comment or query, please contact the KG lawyer you are in contact with or the Pharmaceutical Law practice team.
Kyriakides Irene
Partner
Email: [email protected]
Charalabopoulou Nefelie
Senior Associate
Email: [email protected]
Main (Athens) Offices
28, Dimitriou Soutsou str.,
115 21, Athens
Thessaloniki Branch
17, Ethnikis Antistaseos
551 34 Thessaloniki
Greece
Tel: +30 210 8171500 Τel: +30 2310 441552
Fax:+30 210 68 56 657/8
www.kglawfirm.gr