For more information please contact Government Affairs & Policy Advisor Amalija Pavić at pavic@amcham.rs or Regulatory Affairs Coordinator Milica Samardžić at samardzic@amcham.rs
AmCham Health Care Committee began its work as Health-Care Task Force, in February, 2009, involving representatives from the pharmaceutical and medical devices industries as well as insurance and health-services providers. The group aims to establish constructive dialogue with the Ministry of Health and related institutions to promote and develop private sector contributions to improvements in the health-care system in Serbia. Due to its strong advocacy drive and significant interest of the member companies, the HCTF turned into an AmCham Health Care Committee as of 2011.
In first half of the year, Committee representatives met with new Minister of Health (MoH) Zoran Stanković and Assistant Minister Zorica Pavlović to discuss priority topics from the Committee’s agenda: lack of transparency and procedure in the HIF by-law on the criteria, manner and procedure for accessing/delisting from the List of Medicines, the breach of deadlines prescribed by the law in case of Agency for Medicines and Medical Devices (ALIMS) and the dangers of an ensuing liquidity crisis.
Representatives of the Ministry showed readiness to support AmCham proposals for amendments of the HIF Rulebook installing clear procedure, which AmCham sent to the Ministry following the meeting. Finally, the Committee submitted a letter to HIF regarding irregularities in the medicines list in terms of defining the limits to prescribing drugs.
In the second half of the year, the Committee joined forces with Inovia and the Group of Pharmaceutical Manufactures of the Chamber of Commerce and Industry of Serbia and sent a joint letter to the Ministry of Health and Agency for Medicines and Medical Devices regarding procedure for renewal of drugs registration and promotion of medicines. Specifically, they emphasized that the Law on Medicines and Medical Devices’ provision on renewal of drugs registration does not correspond to the administrative capacity of the Agency and should be changed. The current solution could create an administrative barrier that could significantly affect the supply of drug markets of Serbia.
.As an outcome of two rounds of comments sent during the second half of 2009 to the Ministry of Health, the Law on Medicines and Medical Devices adopted in May, included most of AmCham’s comments and recommendations. In addition, changes to the Law on Health Care, in line with AmCham comments, were adopted by the Parliament in November. In early February, representatives of pharmaceutical companies, both generic and innovative, joined forces with the Inovia fund and the Group of Domestic Producers of Medicines within the Serbian Chamber of Commerce. The group sent a letter to the Minister of Health and the Minister of Trade requesting the opening of a technical dialogue regarding installing a mechanism for adjustments of medicine prices in line with the exchange rate. Although the price of medicines has been changed twice since, the call for technical dialogue with regard to installing the exchange rate adjustment mechanism remains unanswered. The Health Care Task Force initiated monthly consultative meetings with the Director of the Serbian Health Insurance Fund (HIF) in February, and four such meetings were held before the new Director came into office. The group continued its cooperation with the new Director, who promised improved response by the Fund in future. He also welcomed suggestions for improving the efficiency of the HIF in terms of the transparency of internal procedures and response to applications.
Moreover, the Health Care Task Force met twice with the Minister of Health, Tomica Milosavljević, to discuss a wide range of policy issues from prices of medicines and transparency of reimbursement regulations and their implementation to opportunities for private-public partnerships (PPP). The Minister said he was open to improving reimbursement regulations and invited AmCham to submit suggestions in writing.
As a follow-up to a meeting with the new Director of HIF and the Minister of Health, the AmCham Health Care Task Force submitted a list of suggestions for improving the internal procedures of the Health Insurance Fund with a special emphasis on procedures for moving medicines on and off the Reimbursement List in line with EU Transparency Directive.
.Key facts | Progress/Achievements |
Established in 2009 | Gathers representatives of pharmaceutical & medical devices industries, private healthcare providers, insurance companies |
Commented on key regulations | • Law on Medicines and Medical Devices - key suggestions adopted • Law on Health Care - key suggestions adopted • Foreign Exchange mechanism regarding the Price Decree – not answered, nor adopted • Rulebook on the promotion of medicines - key suggestions adopted • Rulebook on the inner and outer package of medicines – pending adoption • Rulebook on the quality control of medicines – pending adoption • Suggestion for improving internal procedures of the Serbian Health Insurance Fund - recent |
Established regular channel of communication with the policy makers | • 5 meetings with the Director of HIF (2 introductory and 4 technical) • 2 meetings with Minister Milosavljević and 1 technical meeting with Ministry of Health staff • 1 introductory meeting with the Director of the Agency for Medicines and Medical Devices |
Organized Seminars and Roundtables | • Seminar on prevention of swine flu - joint initiative with HR Task Force • Ethics in healthcare during AmCham’s Business Ethics Week |