News – New regulation found after the CAMbrella deliveries:
Albania receives EU Candidate status on June 27, 2014.
Notice! All text below is copied from the CAMbrella report – delivered Dec 31, 2012
In this summary, you will find:
- Direct links to the legislation of specific CAM therapies in Albania
- The legal and regulatory status of CAM and CAM practices in Albania
- The governmental supervision of CAM practices in Albania
- The reimbursement status of CAM practices and medicinal products in Albania
Go directly to legislation of specific CAM therapies in Albania:
Acupuncture – Anthroposophic medicine – Ayurveda – Chiropractic – Herbal medicine/Phytotherapy – Homeopathy – Massage – Naprapathy – Naturopathy – Neural therapy – Osteopathy – Traditional Chinese Medicine (TCM) – Other treatments
The Republic of Albania (hereafter Albania) applied for European Union (EU) membership on 28. April 2009 and is listed as a potential candidate country to EU (11). Albania is connected to the FP7 research programme through a memorandum of understanding and as such included in the CAMbrella survey of CAM legislation in Europe. Albania has been a member of the Council of Europe since 1995 (12).
The legal and regulatory status of CAM and CAM practices
In Albania alternative medicine is regulated, and some CAM treatments are mentioned in
the regulation. Article 20 of “Law on Health Care in the Republic of Albania” from 2009
states that (13);
- Alternative Medicine is a set of preventive and curative health practices, such as
homeopatia, naturopatia, chiropractic and herbal medicine, which does not follow the general medical methods that are accepted and may not have a scientific explanation for their effectiveness.
- Treatments, conditions and manner of use of unconventional therapeutic methods are
determined by order of the Minister of Health.
- Advertisement and practice of alternative medicine methods unlicensed by the Ministry of Health are prohibited.
There are no follow-up regulations of this activity approved by the Ministry of Health
(MOH). Article 19 of the health care law of 2009 regulates sport and rehabilitation medicine, including physiotherapy (see below)(13).
Article 31 states that registration of health professionals is a mandatory process, headed by the Ministry of Health. Operational orders are regulated by separate laws(13). Article 33 states that the Ministry of Health establishes mandatory programs for continuing education (CME) for health care professionals (13).
Albania has a health care system that is mainly public (14). Private medical practice has been legal since 1992 (15). Private practice licences are no longer issued by the MOH. The private sector includes most of the pharmaceutical services (14).
The Act on regulated professions in Albania from 2009 applies to every person who wants to exercise a regulated profession in the Republic of Albania. The law does not apply for the professions, which, according to the legislation in force, have special requirements, but not necessarily the character of formation or qualification required for regulated professions (16). According to the professionals act article 5, regulated health professionals in Albania are doctor, dentist, pharmacist, nurse, midwife, physiotherapist and veterinarian (16).
A. To earn the right to exercise a regulated profession, each candidate must:
a) Perform professional practice.
b) Perform the state examination.
c) Be registered in the respective UP (national professional register) (16).
The governmental supervision of CAM Practices
Law on health care 2009 article 4 states that the Health Minister directs the policy,
organization and supervision of the health care system (13). According to the law on Public Health, inspection shall be performed by the State Health Inspectorate as a dependant body to the Minister of Health, and the Chief Inspector of state health, in order to perform his duties, shall technically rely on the Institute of Public Health (17).
Regulated health services and regulated health professionals (including CAM licensed
professionals) are included in the supervision programme under the State Health
Inspectorate. The Ministry of Health has special attention to “The National Centre of Quality, Safety and Accreditation of Health Institutions” and “The Centre of Continuous Medical Education” to increase their authority (14).
The reimbursement status of CAM practices and medicinal products
The Health insurance scheme in Albania is governed by law Nr. 10 383, dated 24 February 2011 on Compulsory Health Care Insurance (18). “This law defines the legal status, the structure, functions and the activity of the Health Care Insurance Fund which manages the funding of the health care services onto the compulsory health care insurance scheme”(18).
The health care insurance scheme in Albania covers health care services funded by the
private and public sector (18). Patient services covered are:
a) medical examinations and treatment in public health care centres and public
hospitals and additional services in public hospitals.
b) medical examinations and treatment in private medical practices and private
hospitals to an extent agreed with the Health Insurance Fund (HIF).
c) drugs, medical products and treatment by other persons in the medical profession.
The Health Insurance Institute (HII) was established in 1995 as a national statutory body.
Reimbursement coverage has been introduced and extended in planned stages. Additional
funding comes from patients and foreign aid. Even if patients co-payments is low, it is likely that out-of-pocket payments prevent low-income people from obtaining health care services and pharmaceuticals (15). Private insurance has been legal in Albania since 1992 (15).
Medical doctors are employed by the State, general practitioners (GP’s) are paid by the
Health Insurance Institute (HII) according to a capitation system, specialists are paid a fixed salary by the MOH (19).
The pharmaceutical services in Albania are mainly private with rigorous monitoring from the MoH and the National Center of Drugs Control (14). The Drug Commission on Drafting and Reviewing the Reimbursement List selects the drugs that are going to be reimbursed (14). In 2009 450 drugs were on the reimbursement list. Albania collaborates with the European Drug Agency to adjust national legislation to the European Union Directives (14).
The health insurance act of 2011, article 10 includes insurance services by defining: “the list of reimbursable drugs and also the measure of coverage from compulsory insurance. The structure of the drug list is defined based on the list of the basic drugs according to
classification INN (active principle of drug) as defined by WHO and also to the cheapest
The Instrument for Pre-accession Assistance (IPA) programme was launched by the
European Medicines Agency in late 2009 in order to support and foster links between the
European Medicines Agency and the Beneficiaries (including Albania) in order to ensure
future co-operation in the Agency’s networks and to prepare the countries for integration
into the European regulatory network for medicines.