Concept Note

The Working Group for Research on the Competition Issues in the Pharmaceutical Sector

The mission of the Working Group for Research on the Competition Issues in the Pharmaceutical Sector is:
1. to promote development of competition environment in the pharmaceutical market;
2. to ensure the availability of medicines to the population.

Objectives of the Working Group:
1. Sharing experience in and approaches to antimonopoly law enforcement in the pharmaceutical market;
2. Coordinating activity of the Competition Authorities (members of the Group) during investigation of the antimonopoly law infringement.

Questions to be discussed within the frameworks of the Working Group:
1. Research on approaches to determination of the interchangeability of medicines in different countries, particularly:
• existence of the register of interchangeable medicines;
• determination of the interchangeability of medicines;
• is it possible if medicines with a different international non-patented name (hereinafter INN) could be treated as interchangeable;
• the procedure that should be completed to receive the state of interchangeability.

2. Research on approaches to determination of the interchangeability of medical products, medical equipment, including sophisticated medical equipment, and consumables in different countries, particularly:
• existence of the register of interchangeable medical products, medical equipment, including sophisticated medical equipment, and consumables.

3. Research on problems arising as a result of cooperation of pharmaceutical companies with medical communities of different countries, particularly:
• existing requirements and restrictions in relation to interaction of the pharmaceutical companies with doctors and with medical equipment suppliers.

4. Circulation of Biologically Active Supplements (hereinafter BAS):
the procedure of registration of BAS;
how BAS is recognized (as a medicine or not);
regulation of circulation of BAS.

5. The issues related to the procedure of amending instructions on medical application of original medications and generics in case of finding additional therapeutic effects, contraindication or side effects.
• the procedure of amending the instructions;
• is it necessary that this procedure should be completed on the national level/on the level of the EC or on both levels;
• are the amendments to the instructions on medical application of a medicine synchronized in all the national jurisdictions;
• may there be differences in the instructions on medical application of the medicines under the same INN but with different trade names;
• what would be with the instruction on medical application of a generic medicine if the instruction on application of the original medicine was amended;
• shall the instructions on medical application of an original medicine be conformed with the instructions on application of the medicines of the same producer that are registered in other countries? In what way is the procedure of bringing to conformity supervised.

6. Issues relating to post-approval control over activity of pharmaceutical companies and activity on producing and selling of the medical equipment.
Interaction within the frameworks of the Working Group is performed in the following forms:
- consultations;
- meetings with representatives of respective state authorities, business and other relevant parties;
- exchange of information;
- coordination of activity of the Competition Authorities (members of the Group) during investigation of the antimonopoly law infringement.

Co-chairs of the Working Group:
• The FAS Russia;
• Italian Competition Authority;