Panel themes of the International Conference

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• Panel themes of the International Conference
• Europe against Counterfeit Medicines

G.N. Gildeeva, Deputy head of the Department of
Registration of Medicines and Medical Devices,
Federal Inspectorate for Health and Social
Development (Roszdravnadzor)
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Aims

• Help create effective legislative machinery to
  reduce the number of counterfeits on the
  pharmaceutical market, improve law enforcement
  practice and develop co-operation between the
  Russian Federation and member states of the
  Council of Europe, the EU and the WHO
• Draft an appropriate legal instrument
  (convention) on international co-operation in the
  fight against counterfeit medicines
• Secure a consensus between the public and private
  sectors as regards practical measures to protect
  society and the economy from the detrimental
  consequences of counterfeit medicines
• Ensure effective sharing of information and best
  practice, by establishing a network of Single
  Points of Contact in the relevant state agencies,
  most notably healthcare institutions
• Create a special network of quality control
  laboratories in the Russian Federation in
  consultation with the European Directorate for
  the Quality of Medicines (EDQM).

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Russian participants

• Officials from the Russian federal executive and
  legislative authorities
• Officials from the regulatory oversight and
  security agencies
• Representatives of the agencies involved in the
  fight against counterfeit medicines
• Officials from the RF Government and the
  Presidents Office
• Representatives of the CIS countries
• Representatives of international and European
  institutes and organisations, and private
  companies involved in the manufacture and sale of
  pharmaceuticals
• Representatives of patient and consumer
  protection groups
• Pharmaceutical industry organisations and
  associations

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Some basic facts

• The counterfeiting of medicines is a global
  problem.
• Counterfeit medicines pose a threat to the
  nations health.
• Any counterfeit medicine has the potential to
  damage the patients health.
• Counterfeiting medicines has a direct negative
  impact on consumers and manufacturers alike.
• The system of combating the spread of counterfeit
  medicines will only work if there is an
  appropriate legislative framework.
• The counterfeiting of medicines can be prevented
  only if all members of society make a concerted
  effort.

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Panel 1 Government, enforcement and training
perspectives

• Moderator A.A. Toporkov, deputy head of the
  Department of State Regulation of Trade in
  Medical Products and Methods of Rehabilitating
  People with Disabilities, Roszdravnadzor
• Key themes
• National strategy for combating trade in
  counterfeit medicines
• Law enforcement agencies combating trade in
  counterfeit medicines
• Training staff in the healthcare sector, customs
  authorities, Ministry of Internal Affairs,
  judiciary, etc., to combat trade in counterfeit
  medicines and fight crime in this area by legal
  means
• Inter-ministerial co-ordination

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Panel 2 Legislative agenda

• Moderator Boris Spiegel, deputy head of the
  Federation Council Committee on Science, Culture,
  Education, Healthcare and Ecology
• Rapporteur I.V. Filippov, State Duma
• Key themes
• Current Russian legislation to combat trade in
  counterfeit medicines
• Administrative regulation of interaction between
  the competent ministries and law enforcement
  agencies
• Objectives of international co-operation

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Panel 3 International co-operation
laboratories and analytical controls

• Moderator V.V. Kosenko, head of the Department
  of State Regulation of Trade in Medical Products
  and Methods of Rehabilitating People with
  Disabilities, Roszdravnadzor
• Rapporteur R.I. Yagudina, director of the
  Institute of Information Technology, Federal
  State Agency Research Centre for the Evaluation
  of Medicinal Products, Roszdravnadzor
• Key themes
• The system of state control and monitoring of
  medicines
• Practical experience of organising expert testing
  of medicines
• Development of the regional medicine quality
  control service

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Panel 4 Public-private perspectives and
partnership in the public health sphere

• Moderator D.V. Parkhomenko, deputy head of the
  Department of State Regulation of Trade in
  Medical Products and Methods of Rehabilitating
  People with Disabilities, Roszdravnadzor
• Rapporteur L.V. Titova, Association of Russian
  Pharmaceutical Manufacturers, Russia
• Key themes
• Measures to make patients, consumers and staff
  aware of the potential risk and possible
  consequences of using counterfeit medicines
• Role of pharmaceutical and medical workers
  organisations, the media, consumer and patient
  protection groups
• Interaction between the state and manufacturers
  in combating trade in counterfeit medicines

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Panel 5 Best practices to protect consumers and
the market

• Moderator V.A. Dmitriev, Roszdravnadzor, Russian
  Federation
• Rapporteur F.Y. Vartanyan, Russian Medical
  Academy of Postgraduate Studies, Moscow Key
  themes
• A system for controlling the quality of medicines
  and detecting counterfeits
• Technologies for combating the manufacture of and
  trade in counterfeit medicines

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Panel 6 European Directorate for the Quality of
Medicines (EDQM)

• Moderator G.N. Gildeva, deputy head of the
  Department of Registration of Medicines and
  Medical Devices, Roszdravnadzor
• Rapporteur V. L. Bagirova, Director of the
  Institute of Standardisation and Regulation of
  Medicines, Federal State Agency Research Centre
  for the Evaluation of Medical Products,
  Roszdravnadzor
• Key themes
• Issues relating to the standardisation of
  medicines prospects for the harmonisation of
  the Russian Pharmacopoeia with the European
  Pharmacopoeia
• Co-operation with the European Directorate of the
  Quality of Medicines

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Conclusion

• The programme to combat trade in counterfeit
  medicines will only work if the necessary
  legislation is put in place, and strictly
  enforced. This requires concerted efforts and
  co-operation on the part of both civil society
  and the private sector.
• In order to implement practical measures to
  improve the safety of medicines, close contacts
  needed to be developed at all levels of
  government in the Russian Federation with the
  Council of Europe.
• An international convention to combat trade in
  counterfeit medicines needs to be adopted within
  the framework of the Council of Europe.