Albania | Cam-Regulation

Albania

Summary of the country's general legislation of CAM.

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 April 28, 2009 and received EU Candidate status on June 27, 2014 . 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);

  1. 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.
  2. Treatments, conditions and manner of use of unconventional therapeutic methods are determined by order of the Minister of Health.
  3. 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 alternative” (18).

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.

Sources

11. EUROPA. Gateway to the European Union; member countries. Brussels EUROPA
Communication department of the European Commission; 2011 [cited 2011 November 3]; Available from: http://europa.eu/about-eu/countries/index_en.htm.

12. Council of Europe. Council of Europe. Strasbourg: Council of Europe; 2011 [cited 2011
November 7]; Available from: http://www.coe.int/lportal/web/coe-portal.

13. Assembly of the Republic of Albania. LAW No. 10 107, dated 30.3.2009 on Health care in the Republic of Albania Pursuant to Articles 78 and 83 1 of the Constitution, proposed by the Council Ministers; Article 20 Alternative medicine; Article 19 Physiotherapy. 2009 [cited 2012 March 8]; Available from:
www.moh.gov.al/faqet/ligj /Per%20kujdesin%20shendetesor%20ne%20republiken%20e%20shqiperise.pdf
www.moh.gov.al/index.php?module=2&item=57.

14. The Republic of Albania Ministry of Health. An overview of the health care system in Albania; some performance indicators. Tirana: Ministry of Health 2009.

15. Nuri B. Health Care Systems in Transition: Albania. Copenhagen: European Observatory on Health Care Systems: WHO Regional Office for Europe 2002 Contract No.: EUR/02/5037245 (ALB) 2002.

16. Assembly of the Republic of Albania. Law No. 10171, dated 22.10.2009 “On the regulated professions in the Republic of Albania Pursuant to Articles 78 and 83 1 of the Constitution, proposed by the Council of Ministers: LIGJ Nr.10 171, datë 22.10.2009 PËR PROFESIONET E RREGULLUARA NË REPUBLIKËN E SHQIPËRISË. Pharmacist’s order of Albania, 2009 [cited 2012 March 15]; Available from: http://www.pronaindi.com/ufsh/index.php?option=com_content&view=article&id=80:ligj-perprofesionet-e-rregulluara-ne-republiken-e-shqiperise&catid=39:ligjshmeria&Itemid=84.

17. Assembly of the republic of Albania. LAW No. 10 138 Dated 11. 05. 2009 FOR THE PUBLIC HEALTH Pursuant to articles 78 and 83, item 1 of Constitution, upon the proposal of Council of Ministers. MInistry of Health Albania2009 [cited 2012 March 8]; Available from: http://www.moh.gov.al/faqet/ligje/en/For%20the%20Public%20Health.pdf.

18. The Parliament of the Republic of Albania. Act Nr. 10 383, date 24.2.2011 on compulsory health care insurance. 2011 [cited 2012 March 8].

19. Council of Europe. Summary Health Care Council of Europe; 2008 [cited 2011 November 4];Available from: www.coe.int/t/dg3/socialpolicies/…/EN-2-Summary-2008.pdf.

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