Improving Access to Information on Drug Safety (MN0058)

What problem does the commitment aim to address? 1.Publish information in the open information electronic system (www.shilen.gov.mn). 2.Maintain open information transparency, criteria of transparency will be established and evaluated. 3.Improve the electronic registration and control system of drug safety.

What are the causes of the problem? When monitoring government activities, citizens, NGOs, and the private sector’s participation is not sufficiently justified. Incomprehensive information and lack of coordination at government decision-making is creating irrational decisions.

What has been done so far to solve the problem? 1.Under the joint orders of the Minister of Justice and Home Affairs and the Minister of Digital Development and Communications No. A/268 and A/48 dated September 19, 2022, Council responsible for organizing, evaluating, and making recommendations on the implementation of open information transparency was established. 2.In accordance with the joint orders of the Minister of Health and the Minister of Digital Development and Communications No. A/509, A/60 of 2022, the main database of the "Licemed" program was placed in the National Data Center to create the possibility to obtain and monitor drug information related to the quality, safety, and production. Using the E-Mongolia system, legal entities and organizations can access the system to register, extend, modify and regulate biologically active products, imported drugs, domestically produced drugs, traditional drugs, and raw materials of drugs. As a result, more than 100 drug supply organizations have the opportunity to receive these services online. According to October 30, 2023 statistics, legal entities and organizations submitted 4512 requests to the state information platform E-Mongolia for 14 services, including registration, extension, modification, and regulation of biologically active products, imported drugs, domestically produced drugs, traditional drugs, and raw materials for drugs, and 4711 requests were made through the E-Business platform for 20 services.

What solution are you proposing? 1.Data controller uploads the open information to the http://www.shilen.gov.mn electronic system; 2.Maintain open information transparency, establish and evaluate transparency criteria; 3.Improve the electronic registration control system of drug safety.

What results do we want to achieve by implementing this commitment? Short term: -Accustom to publish complete and accurate open information; -Maintain open information transparency, establish and evaluate transparency criteria; -Improve the operation of LICEMED software; -Link drug information with electronic system of government services e-Mongolia. Long term: - Ensure the implementation of the Law on the Public Information Transparency; - Create an electronic system of drug safety.

Milestones | Expected Outputs | Expected Completion Dates

2.1.Publish open information in the "www.shilen.gov.mn" system. | Organizations responsible for information will publish open information on a regular basis. | 2024-2025

2.2.Improve the electronic system of regulation and control of medicines and medical devices. | -Transparency of control and regulation of medicines and medical devices will be ensured, coordination of activities will be improved. -The necessary information on drugs sold in Mongolia such as ingredients, validity period, import and origin of drugs will be disseminated transparently and openly for citizens. | 2024-2028

2.3.Create a unified database of extractive industry and disseminate open data. | Open data will be compiled and distributed through a unified extractive industry database. | 2024-2027

2.4.Disclosure information on contracts, financing and operational results of general budget administrators collaborating with NGOs. | Citizens' control over budget performance and contract implementation will be improved. | 2024-2027

Action Plan Review

Commitment 2. Safeguarding Freedom of Information

Commitment 2 aims at safeguarding freedom of information by clarifying the criteria for disclosing government-held information on the http://www.shilen.gov.mn portal. Milestone 1 does not offer clear information on what would be done to improve citizens’ access to public information. Meanwhile, the evaluation of open data transparency across ministries, agencies, local administrations, and other public institutions by the Ministry of Digital Development and Communications prior to the action plan implementation period shows an overall good level of compliance—the majority scored above 90% and none scored lower than 50%. [35] Milestone 2 on electronic regulation and control of medicines and medical devices repeats a similar objective from the previous action plan, [36] but is not relevant to an OGP value. Milestones 3 and 4 on the creation of an integrated extractive industry database and participation of civil society in extractive governance oversight are redundant to an identical milestone of Commitment 1. In order to achieve meaningful results, this commitment could aim to train government officials on proactive data disclosure and establish a participatory mechanism for citizens to analyze gaps in existing data, identify priority data to disclose, and evaluate the accuracy and reliability of government data.