Natalia SpivakSpecializations: Pharmaceutical Regulatory, Advertising and Promotion, Policy Making
- Taras Shevchenko National University (Kyiv), Department of Law
Natalia Spivak has a deep expertise in legal consulting on regulation in healthcare, pharmaceutical and medical devices’ industry.
As a part of Legal Alliance Company’s team Natalia Spivak was involved in implementation of projects on development of amendments to Laws of Ukraine, Resolutions of the Cabinet of Ministers, Orders of the Ministry of Health, that regulate medicinal products market. The work on the draft Law of Ukraine “On Medicinal Products” required a profound comparative study of the respective European legislation and practices in the following spheres: state registration of medicinal products, pharmacovigilance, licensing of medicines turnover, quality control, etc.
During last two years Natalia Spivak has been working in a team of lawyers consulting the Ministry of Health of Ukraine and the Management Science for Health international organization, which has implemented the project “Systems of Improved Access to Medicinal Products and Pharmaceutical Services” (SIAPS) in Ukraine aimed at introducing the National List of Essential Medicines based on the current model of the World Health Organization.
Also Ms. Spivak participated in legal support for development of the National Drug Policy based on international experience in order to harmonize the legislation of Ukraine with the EU legislation.
From September 2017 to February 2018 Ms. Spivak acted as a national legal consultant of the Partnership “Stop Tuberculosis”. She worked in the expert team on legal environment assessment regarding tuberculosis.
Natalia Spivak was repeatedly involved in the consulting the Ministry of Health of Ukraine concerning the reforming of state price regulation on medicinal products, introduction of reimbursement in Ukraine, legal support for receiving licenses on wholesale and import of medicinal products, comprehensive analysis of promotional materials for medicinal and cosmetics products, as well as drafting of contracts between pharmaceutical market actors on various subjects. Inter alia, she worked in a team on the following issues:
Ms. Spivak has publications on pharmaceutical regulation as well as advertising and promotion. Also she was a guest speaker on pharmaceutical conferences, seminars and round tables.
- Legal support to the Ministry of Health of Ukraine on introduction of medicinal products reimbursement program “Affordable Medicines” and implementation of this program.
- Advising pharmaceutical market actors on price regulation for medicinal products and medical devices, in particular, those procured for budgetary funds.
- Development of draft amendments to orders of the Ministry of Health of Ukraine on improving the procedure of medicinal product ex-factory prices declaration.
- Legal support for the process and development and approval of bylaws on qualification requirements to heads of healthcare institutions, improvement of bylaws on contest for the position of heads of state and communal healthcare facilities and making contracts with them.
- Development of regulatory acts in the area of control over observance of rights and ensuring safety of patients at medical care provision (regarding supervisory and guardian councils of healthcare facilities) and accompanying their approval.
- Legal support for the process of development of the Law of Ukraine which sets the qualification of healthcare facilities and peculiarities of their functioning.
- Development of pharmacovigilance, distribution agreements, etc.
Natalia Spivak has a number of published works on pharmaceutical regulation, as well as advertising and promotion. She also regularly gives speeches at conferences, seminars and roundtables on pharmaceutical issues.
- Draft Law of Ukraine “On Medicinal Products” No. 2162, registered in the Parliament in February, 2015.
- Resolution of the Cabinet of Ministers of Ukraine No. 1134 dated December 9th, 2015 “On Amendments to the Resolutions of the Cabinet of Ministers of Ukraine No. 955 dated October 17th, 2008 and No. 333 dated March 25th, 2009”;
- Resolution of the Cabinet of Ministers of Ukraine No. 547 as of July 4th, 2017 “On Amendments to Resolution of the Cabinet of Ministers of Ukraine No. 333 dated March 25th, 2009”
- Resolution of the Cabinet of Ministers of Ukraine No. 718 as of September 27th, 2017 “Some Issues of Drug Procurement”
- Order of the Ministry of Health of Ukraine No. 84 dated February 2nd, 2016 “On Approval of the Regulation on National List of Essential Medicines and the Regulation of Expert Committee on Selection and Use of Essential Medicines” etc.
- Order of the Ministry of Health of Ukraine No. 1050 as of October 7th, 2016 "On Approval of the Regulation on the Selection of Medicines for Inclusion in the National List of Essential Medicines";
- Order of the Ministry of Health No. 782 as of July 11th, 2017 "On Approving the Procedure for Determining the Required Quantity for Procurement of Medicines by Healthcare Institutions and Facilities Wholly or Partially Financed from State and Local Budgets";
- Order of the Ministry of Health of 17.07.2017 No. 801 "On Approval of the Regulation on the Application of the National List of Essential Medicines for the Organization of the Provision of the Population with Medicines in Health Care Institutions and Institutions Wholly or Partially Financed from the State and Local Budgets";
- Order of the Ministry of Health No. 885 as of August 1st, 2017 "On Amendments to Orders of the Ministry of Health of Ukraine No. 84 as of February 11th, 2016 and October 7th, 2016 No. 1050";
- Resolution of the Cabinet of Ministers No. 1081 as of December 13th, 2017 "On Amendments to the National List of Essential Medicines" and Resolution of the Cabinet of Ministers No. 1009 as of December 13th, 2017"On Amendments to Clause 1 of Resolution of the Cabinet of Ministers of Ukraine No. 1303 as of August 17th, 1998";
- Draft National Policy on Providing Population with Medicines;
- Resolution of Cabinet of Ministers of Ukraine No. 1077 as of December 27th, 2017 "On the Supervisory Board of the Healthcare Establishment and Amendments to the Standard Form of Contract with the Head of the State or Communal Healthcare Facility";
- Resolution of Cabinet of Ministers No. 1094 as of December 27th, 2017 "On Approval of the Procedure for Holding a Contest for the Position of the Head of the State, Communal Healthcare Facility"
- Draft Order of the Ministry of Health "On Amendments to the Handbook of Qualification Characteristics of Professions." Issue 78 "Public Health" and others.
- Ukrainian Bar Association
- European Business Association