The GOVERNANCE of the health system with regard to COVID-19 relates to pandemic response plans and the steering of the health system to ensure its continued functioning. It includes emergency response mechanisms, as well as how information is being communicated, and the regulation of health service provision to patients affected by the virus.
Bosnia and Herzegovina has a complex governance system, with devolved responsibility for the design and implementation of public policies, in particular in health and education. The country administratively consists of and is governed as two independent political entities: the Republika Srpska (RS) and the Federation of Bosnia and Herzegovina (FBIH), and one autonomous district: the Brcko District of BIH (BD BIH).
RS has 7 administrative (non-autonomous) regions and 63 municipalities; FBIH has 10 autonomous cantons and 79 municipalities. Health care is within the responsibility of the entity government in the Republika Srpska, and cantonal governments in FBIH, coordinated and governed by the entity government of FBIH. At state level, the Ministry of Civil Affairs (MoCA BIH) has a legal role to coordinate activities related to population health and health care services, including some activities related to international engagement and data collection. In practice, however, the MoCA’s involvement in the health care domain is limited to some aspects of international engagement.
There was no pandemic response plan in place before the outbreak.
No emergency legislation been adopted to deal with the pandemic. At BIH level, a state of emergency was declared by the Council of Ministers on 17 March. According to the law (http://www.msb.gov.ba/onama/struktura/zastita_spasavanje/dokumenti/zakoni/default.aspx?id=6805&langTag=en-US), the Ministry of Security of BIH is in charge of co-ordinating the BIH response to COVID-19. On 2 June, the Minister of Security of BIH resigned, claiming three reasons for his resignation: (i) disagreements over the management of the migration situation in BIH; (ii) unconducive relations among the ruling political parties in BIH to which he is supposed to be in the opposition, and (iii) scandals with public procurement during the COVID-19 crisis in BIH and unacceptable political pressures on the judiciary and prosecution.
The Ministry of Security of BIH retains its primary authority over the border police of BIH, and coordinates police and civil protection response in all entities of BIH. The Ministry of Civil Affairs of BIH coordinates the responses of all BIH entities within the health sector. However, their constitutionally separated health systems are under the primary authority of their respective line ministries in the governments of FBIH (including its 10 cantons), RS and BD BIH.
Both the FBIH and RS governments declared a state of emergency on 16 March. In RS, the Coordination Body for the response to COVID-19 was initially under the MoH of RS, but after 26 February it was transferred to the authority of the Prime Minister of RS.
In FBIH, a Crisis Management Committee was established on 4 February, under the local Ministry of Health, composed of 21 individuals with predominantly public health expertise. On 25 March, the Committee was restructured and put under the direct authority of the Deputy Prime Minister/Minister of Finance of FBIH, with 7 members from the FBIH administration for civil protection, police, public health, commodity reserves and the Red Cross, thus becoming the FBIH Crisis Headquarters (HQ) The Prime Minister of FBIH commented that the Committee ‘was too big and did not respond well to the needs of citizens. It did not respond to tasks, such as medical equipment procurement.’
Very strong public reactions and a criminal investigation resulted from a blatant abuse of fast-track emergency public procurement procedures by the FBIH HQ, when it was realised that a small agricultural/raspberry growing company had purchased 100 medical ventilators from China, worth BAM 10.5 million, upon approval from the FBIH Crisis HQ/Government (29 April). Further investigations revealed that the ventilators (80 of which meanwhile arrived at Sarajevo airport on 30 April) had been purchased without pre-approved technical specifications and import permissions, and as such were not suitable for use in COVID-19 IC units in FBIH. In addition, these ventilators appeared to have been overpaid for by a large margin (https://www.nytimes.com/aponline/2020/05/11/world/europe/ap-eu-bosnia-ventilators.html). Under strong public pressure, all COVID-19 related procurements by FBIH Civil Protection authorities were reviewed, with preliminary findings that all COVID-19 related purchases, including lab tests and PPE supplies, were also realized by selected companies which were not primarily registered as medical suppliers. The prosecution started an official investigation and the deputy chief of the FBIH Crisis HQ was suspended from duty as Director of FBIH Department of Civil Protection on 12 May. The investigation culminated on 28 May, when the State Investigation and Protection Agency of BIH detained and investigated the Prime Minister of FBIH, the director of Civil Protection of FBIH, and the owner of the agricultural company which bought the ventilators, under the charges of joint criminal acts, money laundering, forging of official documentation, abuse of authority and bribery (https://www.washingtonpost.com/business/bosnia-officials-firm-owner-arrested-over-ventilator-deal/2020/05/29/8c5de01e-a19d-11ea-be06-af5514ee0385_story.html?utm_medium=Clanak&utm_source=Klix.ba). After hearings at the Court of BIH, they were released on bail pending trial, while being banned from contacting witnesses in this case. This put in jeopardy the functioning of the FBIH government, as these witnesses are ministers in the government, and the Minister of Finance is also Deputy Prime Minister and Head of the Crisis Management HQ in FBIH. A flurry of political accusations and cross-accusations, including strong political pressure towards the Prosecutor’s office and the judiciary ensued in FBIH, while the Prime Minister resumed his duties under court-ordered restrictions on 1 June.
Concurrently, the RS Government terminated the contract for procurement of the mobile hospital in Banja Luka, and the RS Prosecutor’s Office announced that they formed a case dealing with its procurement and importation. Also, other COVID-19 related public procurement (equipment, PPE) in both FBIH and RS came under scrutiny of the responsible prosecution agencies. In RS, the opposition parties claimed that the Health Insurance Fund of RS procured 50 ventilators at enormous price (totalling over BAM 7.8 million), from a supplier from Banja Luka with links with the political elites in RS. The Fund responded that the claims were ‘inaccurate and manipulative, for political purposes’, adding that all procurement was vetted by medical experts and that the price of ventilators spiked during the peak of the pandemic when these were procured, so it could not be compared to average pricing. On 15 July, the dismantled controversial mobile hospital was sold – in the midst of an ongoing investigation – to Turkey for double the price, with a poignant comment from a member of the Presidency of BIH, Mr. Dodik: ‘How is something that reportedly was not good for us now good for Turkey at double the price? No one aimed to trick anyone, we tried to do something good and we were turned into the bad guys.’ (https://vijesti.ba/clanak/500014/ristic-mobilna-bolnica-vracena-iz-rs-prodata-turskoj).
In FBIH, a parliamentary committee established to look into the procurement of 100 ventilators in FBIH reported to the Parliament of FBIH that they could not identify any additional bid from other potential suppliers, thus confirming irregularities in the procurement process (18 June). On 29 June, after a hearing at the Court of BIH, the director of the Agency for Medicinal Products and Medical Devices of BIH was declared a suspect in the case of procurement of ventilators in FBIH, and charged with misuse of office or authorizations and providing certification of a registered medical supplier for the agro-company which procured and imported 100 inadequate ventilators to FBIH.
In the areas first hit with a steady increase in the number of new COVID-19 cases after relaxation of restrictive measures, such as Tuzla Canton in FBIH in early June, lack of equipment and stock-outs of PPE supplies became a major issue. Being aware that local procurement could not ensure timely delivery, crisis management authorities from Tuzla Canton urged responsible authorities at the state and FBIH levels to immediately release from the customs office at Sarajevo airport and distribute adequate equipment and supplies donated to BIH by Qatar and the United Arab Emirates back in May 2020. On 29 June, the Coordination Body for Protection and Rescue of BIH was supposed to meet and endorse the decision on the distribution of donated medical equipment and supplies; however, the session was cancelled due to the lack of a quorum. On 15 July, University Clinical Centre Tuzla officially submitted a request for 75 (of the 100) controversial ventilators procured by the agri-company for the government of FBIH. Other medical centres in FBIH, such as Zenica, facing imminent stock-outs of testing kits, urged the authorities to finally distribute the medical equipment and supplies bilaterally donated to BIH, instead of being forced to initiate commercial procurement themselves (16 July). Slow and cumbersome in-country distribution of donations was challenged in the media: while donations from multilaterals (EU, UN) found its way to the end users in BIH fast and transparent, secondary distribution of bilateral donations to BIH needs to pass many administrative levels (the Council of Ministers of BIH, often the Ministry of Civil Affairs of BIH, then the entities and lastly cantonal levels in FBIH). This causes major delays and often does not reach its final destination. In response, the Minister of Foreign Affairs of BIH commented that it would be much easier if there were a “state-level ministry of health” (17 July). On 18 August, the Civil Protection Agency of FBIH announced a tender (worth BAM 150,000) for the instalment, transport, and putting into service of 100 contentious ventilators purchased from China, to which nobody applied. The initial bid for companies was thus officially annulled and the Agency contacted directly a company from Nis, Serbia in possession of the necessary license, to explore the possibility of helping with the case (14 September).
The tripartite Presidency of BIH issued a joint statement to all citizens in BIH on 25 March, urging everyone to trust the institutions and follow instructions: “Let's save our lives and health. Let's show responsibility, solidarity and unity because that is a prerequisite for overcoming the challenge we are facing” (in full here: http://ba.n1info.com/English/NEWS/a419563/Bosnia-Presidency-members-address-citizens-amid-coronavirus-pandemic.html). On 28 April, the Presidency of BIH requested the Council of Ministers of BIH to harmonize all outbreak control measures in BIH, i.e. the measures introduced by the respective authorities of FBIH, RS and BD BIH.
There are no fast-track procedures for the regulation and licensing of medical devices and aids, but according to the Law on medicinal products and medical devices of BIH (http://www.almbih.gov.ba/en/_doc/regulative/medicinal_products_and_medical_devices_act.pdf, Art 66), ‘intervention arrangements’ for importation of non-licenced medicinal products and medical devices are allowed, at the request from health authorities of FBIH, RS and BD BIH (Art 66.3), or their joint request in the case of a declared state of emergency in BIH (Art 66.7). This would be permitted to take place without formal approval or marketing authorisation of the regulating body, the BIH Agency for Medicinal Products and Medical Devices.
The news of the ready-to-use Russian vaccine echoed in BIH as well with expectedly different reactions: while FBIH Assistant Minister of Health reiterated that FBIH would follow EU policy and expert guidelines when it comes to procurement of vaccines, the RS Prime Minister said that RS already submitted an offer to ensure Russia’s vaccines are secured in time for RS. On 25 August, Council of Ministers of BIH identified Ministry of Civil Affairs of BIH as the competent institution on behalf of BIH for conclusion of framework contracts under the Agreement on Joint Procurement of Medical Counter Measures, thus enabling BIH to take part in the EU public procurement of medicines and medical supplies for containing Covid-19 pandemic, based on the reported needs and secured funds for procurement from FBIH, RS and BD BIH governments. At the same time, the Minister of Civil Affairs of BIH is authorized to sign framework agreements on behalf of BIH only for those constituencies of BIH which express interest and opt in for this procurement mechanism. On 28 August, Minister of Health of FBIH announced that the Government of FBIH made decision to use EU procurement mechanism for vaccines, and secured funds (USD 13 million) to buy 800,000 doses of vaccine for FBIH (for an estimated 40% of the population). On 16 September, the Council of Ministers of BIH approved an agreement between COVAX facility for the procurement of COVID-19 vaccines and BIH, authorising the Minister of Civil Affairs of BIH to sign the procurement contract with GAVI. Under this arrangement, the costs of vaccines will be borne by the governments of FBIH, RS, and BD BIH, based on their expressed needs.
Public Health Institutes at the level of FBIH, RS and BD BIH are in charge of surveillance; the Sector for Health of Ministry of Civil Affairs of BIH coordinates surveillance at the state level and reports to WHO.
The Ministers of Health in FBIH and RS have appointed referral laboratories in their respective jurisdictions. Additional surge lab capacity is also being mobilized in both FBIH and RS.