New Laws on Drug Supply in Russia Or Where Does M odernization Lead Us?

1. P.A.VorobyevThe Russian Society of Pharmacoeconomics and Outcomes ResearchRSPOR, Prague, 2010 New Laws on Drug Supply in Russia Or Where Does Modernization Lead Us?

2. Over the past year in the country The following laws were adopted: • Lawondrug circulation • Documents on the pricing of pharmaceuticals • Government Decree on the import of drugs into the country Projectsof the following laws were developed: • On Mandatory Health Insurance • New legislation on health care • On the licensing of medical and pharmaceutical activities • Amendments to the Federal Law # 94 – “law-killer” • And a number of others…

3. All this leads to Entirely new situation in drug supply of citizens Unclear prospects for its development

4. It should be mentioned • Community of experts and stakeholders accepted all this initiatives negatively • Proposals to change projects of documents were accepted aggressively by its developers • All proposals were not taken into account Absence of consensus means that these documents will not work!

5. Article 5. Authorityof federal executive bodies in drug circulation (1) 1) holding a unified state policy in drug supply for citizens on the territory of the Russian Federation; 2) approval of the general pharmacopoeial monographs, pharmacopoeial articles, publication of the State Pharmacopoeia; 3) state control and supervision; 4) licensing the production of drugs and pharmaceutical activities in accordance with Russian legislation; 5) organization of drug examination, ethical assessment of clinical study of drug application; 6) grant of permission to carry out clinical trials of drugs, maintaining a register of permitions to carry out clinical trials of drugs; 7) state registration of drugs, maintaining the state register of medicines; 8) inspection of compliance of drug production with the rules of production and quality control of drugs, issuing reports about compliance with manufacturer's drug requirements and rules of production and quality control of drugs;

6. Article 5. Authorityof federal executive bodies in drug circulation (2) But where is drug supply of population? state registration of the limit selling prices for vital and essential drugs established by manufacturers of drugs and maintenance of the state register of limiting ex-works prices of medicines included in the list of vital and essential drugs; 10) Establishment the procedure for import of drugs into the territory of the Russian Federation and export of drugs from the Russian Federation; 11) establishment of Councils relating drug circulation; 12) certificationof specialists; 13) approval of educational programs for training specialists 14) monitoringofdrugsafety; 15) participationininternationalcooperation; 16) Receiveing information on the establishment and application of the price of drugs and its markup on request of the authorized federal body of executive power from the executive authorities of subjects of the Russian Federation, as well as from subjects of drug circalation; 17) application of accountability measures in case of violations of laws of the Russian Federation.

7. The law stopped registration of new drugs For registration of a drug in Russia clinical trials are required. To get permission for carring out a clinical trial information on insurance of all trial participantsmust be submittedto the MoHSD. It is impossibleto do it for obvious reasons!

8. A huge number of contradictions and inaccuracies led to the following decisions of the RAMS Formulary Committee in May 2010: • The law was adopted • The law can not be executed • The law must be corrected

9. BUT BEFORE - APPEALof the Formulary Committee from 01.04.10 To the President of the Russian Federation Dmitriy Anatolyevich Medvedev from Vice-Chairman of the FormularyCommittee at the Presidium of the RussianAcademy of Medical Sciences,ProfessorP.A.Vorobyev

10. Onbehalfofthe RAMS FormularyCommittee(FC) callonyoutosuspendtheapprovaloftheLaw "Oncirculationofdrugs" andreturnitforrevisiontotheStateDumaduetolackofmajorregulationsandstandardsinit, it wouldworsencurrentdifficultsituationwiththedrugsupplyofcitizens. FC consistentlytriedtocorrectthetextofthisdocumentatallstagesofthe lawapprovement, makingitboththroughtheformalamendment (60) andreferringtoit’sdevelopersthroughthemassmedia. Allproposalswerenottakenintoaccount.

11. One of the most important statements: there is no novel of rare drugs in the law. Currently about 500 rare drugs are registered in the U.S. and Europe, in our country - about 50 rare drugs, only 17 of them are actually available for patients. This situation discriminates some Russian citizens, who can not get adequate treatment and either die (hereditary metabolic disorders, tumors) or become disabled persons (rheumatic diseases, haematologic diseases). There is a special registration technology, research, logistics for orphan drugs in the World, its application is paid by public consolidated budgets.

12. Theappearanceofsustainablefundingintermsofthestateprogramwillleadtothe development ofdomesticanalogues (alreadyexistingexamples - bloodclottingfactors, growthhormone, anticancerdrugs), andwillsignificantly - intimes - reducethecostoftreatment. Theprojectoffederaltargetprogramforraremedicaltechnologies, includingissuesofthesectorofdomesticpharmaceuticalindustry development, developedbytheFormularyCommittee, approvedbythePresidiumoftheRussianAcademyofMedicalSciencesandsubmittedintheprescribedmannertotheMinistryofEconomicsinautumn 2009. Ifthenewlawwillnotincludetheissueofraredrugs, furtherworkontheprogramislikelytobeinfertile.

13. The second novel is the novel of biotech drugs. This issue is closely connected with orphan drugs. Biotechnology have already been developing in our country and implementation of innovative projects could be a powerful impulse for the development of the domestic biotech pharmaceutical industry. It is important that these drugs are not recognized as copies of the original drugs around the world. Patent restrictions that prevent the development of new drugs prior to the expiration of patent rights are not subject to them. Adopted law will limit this area of development of the domestic pharmaceutical industry for many years.

14. The major omissionof the law is the lack of novels concerning the regulation of experts conflicts of interest in decision-making in drug circulation, provision of transparency and consensus of decisions. The law covers a large number of subjects that depend on each other in varying degrees, and these issues must be carefully regulated by law.

15. A short novelon biologically active additives and skin care products appeared in the new law. These terms have not been used in any Russian law before: these tems are marketing rather than legislative. Parapharmaceuticals take from 40 to 70% in the turnover of pharmacies, but parapharmaceuticals have no relation to health. Nowadaysphysicians and paramedics are able to sell it legally in their offices, in addition to pharmacies, this "muddyflow” goes through their hands directly to patients. The world does not know such items.

16. There is nothing on the regulation of prescription and over-the-counter dispensingof pharmaceuticalsin the law, there are no state guarantees of accessibility of drugs for all people. There are no other laws on drugs in Russia, these essential elements of drug circulation will not be regulated in the new law.

17. It is quite surprising In October - 5 months! - the law was hastily adopted with numerous amendments. New amendments have not been discussed publicly and were adopted in 3 readings at once. They removed only one absurdity–clinical studies require PRELIMINARY agreement with the insurance company. New amendments do not change any other issues.

18. Resolution of the Government of the Russian Federation from September 29, 2010 # 771, Moscow "On the order of import of drugs for medical application in the territory of the Russian Federation In accordance with Federal Law "On circulation of drugs" and "On state regulation of foreign trade," The Government of the Russian Federation decrees:Approve the attached regulations for import of drugs for medical application in Russia.The following documents are supposed to be expired:a) Resolution of the Government of the Russian Federation dated 16 July 2005 N 438 "On the order of import and export of medicines for medical use" (Collected Legislation of the Russian Federation, 2005, N 30, art. 3172);b) paragraph 17 of the changes being made in the decree of the Government of the Russian Federation, approved by the Government of the Russian Federation dated 14 February 2009 N 108 (Collected Legislation of the Russian Federation, 2009, N 9, Art. 1101);a) paragraph 5 of the changes being made in the decree of the Government of the Russian Federation on issues related to the improvement of state regulation of prices for vital and essential drugs, as approved by the Government of the Russian Federation on 8 August 2009 N 654 "On improving the state regulation of prices vital and essential drugs "(Collected Legislation of the Russian Federation, 2009, N 33, art. 4086);d) the fifth and sixth items of subparagraph of paragraph 2 of the Government of the Russian Federation dated 30 December 2009 N 1116 "On Amendments to certain resolutions of the Government of the Russian Federation on the regulation of prices for vital and essential drugs" ( Collection of Laws of the Russian Federation, 2010, N 2, Art. 179). Russian Prime Minister Vladimir Putin

19. Regulations for import of drugs for medical application in the territory of the Russian Federation • These Regulations establish the procedure of import of drugs for medical application in the territory of the Russian Federation, except drugs for humanitarian aid (assistance) or assistance in emergency. • These Regulations do not apply to the import of narcotic drugs, psychotropic substances and their precursors listed in Section 2.12. The unified list of goods which have bans or restrictions on the importation or exportation by contries - members of the Customs Union within the Eurasian Economic Community on trade with thee countries, approved solution N 19 on a unified non-tariff regulation of the Customs Union of Belarus, Kazakhstan and the Russian Federation, adopted by the Interstate Council of Eurasian Economic Community on 27 November 2009, and the list of narcotic drugs, psychotropic substances and precursors subjected to control in the Russian Federation, approved by Government of the Russian Federation dated 30 June 1998 N 681.

20. Who can import drugs? а) organizations – manufactures of pharmaceuticals - for domestic production of drugs; б) drug wholesale trade organizations; в) foreign developers of pharmaceuticals and foreign drug manufacturers or other legal entities by order of the developer of pharmaceuticals - to carry out clinical trial, state registration of a drug, including pharmaceutical agent in the state register of medicines and quality control of drugs with the permission of the RF MoHSD to import a specific parcel of drugs; г) research organizations, educational institutions of higher education, and drug manufacturers - to develop, research, monitoring safety, quality and effectiveness of the drug with permission of the RF MoHSD to import specific parcel of drugs for medical application; д) medical organizations, as well as the organizations referred in paragraphs "a" - "d" of this paragraph - to provide medical care for vital indications in a particular patient with the permission of the RF MoHSD.

21. 3. It is prohibited to import adulterated, substandard and (or) counterfeit drugs on the RF territory. 4. Import of drugs included in the list on the territory of the Russian Federation according to the application is supposed to be licensed by the Ministry of Industry of the Russian Federation, except drugs with a status of the goods of the Customs Union. 5. To obtain a license to import drugs legal person referred to in paragraph 2 of this Regulation (hereinafter - the applicant) shall submit to the Ministry of Industry of the Russian Federation on the possibility of licensing for import of drugs issued by Roszdravnadzor (hereinafter - the conclusion).

22. 6. ToobtainconclusiontheapplicantshallsubmittotheRosdravnadzorstatementandanelectroniccopy (inthemannerprescribedbythecustomslegislationoftheCustomsUnion) withtheapplicationsignedandstampedcopiesoftheapplicantthefollowingdocuments:a) Thelicenseoftheactivityinthesphereofdrugs (pharmaceuticalactivities, theproductionofmedicines);b) contractsthatcontaininformationaboutimportedmedicinesandconditionsoftheiracquisition, andinformationonactualpricesofimportedvitaland essential drugsandonthevolumeofimportation. Incaseswhenapplicant'slicensetoimportmedicinesisgiventomediators, contractbetweentheexporter (importer) andproducer (consumer) ofgoodsshouldbeattached;a) incorporationandregistrationdocumentsoftheapplicant (thestatute, thestateregistrationcertificate, certificateofregistrationwiththetaxauthority);d) documentsonstateregistrationofeachoftheimporteddrugswiththecorrespondingregistrationnumbers;e) documentsonstateregistrationoflimitingex-workspricesforimporteddrugsincludedintheannuallyapprovedbytheGovernmentoftheRussianFederationalistofvitaland essential drugs.

23. 7. Roszdravnadzor gives conclusion within a period not exceeding 15 working days from the date of filing under paragraph 6 of this Regulation. In case of a negative conclusion applicant will be notified in writing by the deadline. 8. The basis for the negative conclusion are: a) lack of state registration of the drug; b) the absence of the applicant's license to perform an activity in the circulation of drugs or suspension of such license; c) the restriction on the import of the imported drug according to the international treaty or decision of the Government of the Russian Federation; d) the presence of Roszdravnadzor information that imported drug is adulterated, defective and (or) counterfeit.

24. 9. Drugs for medical application (both unregistered and registered in the Russian Federation,) can be imported into the territory of the Russian Federation without a license to import medicines and without permission of the RF MoHSD, if they are intended to: a) personal application of drugs by individuals who came to the territory of the Russian Federation; b) application of drugs by employees of the diplomatic representatives of international organizations accredited in the Russian Federation; c) treatment of passengers and crew members of vehicles, crews and drivers of vehicles arriving at the territory of the Russian Federation; d) treatment of participants in international cultural and sporting events and participants in international expeditions.

25. 10. Import of a special consignment of unregistered drugs intended for clinical trials, drugs in the examination for state registration, drugs for medical aid in case of vital indications in individual patient (hereinafter - the unregistered drugs) is allowed into the territory of the Russian Federation under the authority of issued by the Ministry of Health and Social Development of the Russian Federation on the applications of legal persons referred in paragraph 2

26. 11. To obtain permission to import unregistered drugs into the territory of the Russian Federation applicant submits to RF MoHSD application and an electronic copy (in the manner prescribed by the customs legislation of the Customs Union), indicating therein the name of the drug and (or) a pharmaceutical substance, dosage form, dosage, concentration, packaging, name of company - the manufacturer of the drug and (or) a pharmaceutical substance, the country of manufacture of the drug and (or) a pharmaceutical substance and attached to them (in addition to the documents stipulated in points "a", "b" and "c" of paragraph 6 of these Regulations) the following documents: a) substantiation of the amount of imported drugs and (or) pharmaceutical substances; b) quality certificate (protocol analysis) of imported drugs (except drugs for medical aid in case of vital indications in individual patient), and (or) for pharmaceutical substances, issued by the organization - manufacturer of pharmaceuticals; c) a copy of approval from the Ministry of Health and Social Development of the Russian Federation to carry out a clinical trial of a drug - in the case of the importation of drugs for clinical trials;

27. Rememberp.6 • the license of the activity in the sphere of drugs (pharmaceutical activities, the production of medicines); • contracts that contain information about imported medicines and conditions of their acquisition, and information on actual prices of imported vital and essential drugs and on the volume of importation. In cases when applicant's license to import medicines is given to mediators, contract between the exporter (importer) and producer (consumer) of goods should be attached; • incorporation and registration documents of the applicant (the statute, the state registration certificate, certificate of registration with the tax authority).

28. Once again about the novel of unregistered drugs g) in case of vital indications in individual patient: Conclusion of council of physicians of federal medical organization, which provide medical assistance to a particular patient, signed by the chief physician (the director) or a person performing his duties, and an electronic copy signed by electronic signature, on the appointment of unregistered drugs to this patient to help due to vital indications and on the necessity of its import; Appeal of the authorized executive body of the subject of the Russian Federation in the form of an electronic document signed by electronic signature, on the necessity of importation of unlicensed medical product for medical aid due to vital indications in individual patient with a copy of conclusion of council of physicians of federal medical organization, which provide medical assistance to a particular patient, signed by the chief physician (the director) or a person performing his duties; copy of passport or birth certificate of the patient who was appointed an unregistered drug due to vital indications, certified by the federal institution (s) providing medical assistance in the form of an electronic document, signed by electronic signature.

29. There is a feeling that in terms of "new order" import of orphan drugs will be almost impossible because I do not know medical organizations with a license for wholesale trade of pharmaceuticals

30. One can proud of it 12. Health Minister of the Russian Federation within a period not exceeding 5 working days from the receipt of the application for getting permission to import unregistered medicines and the documents referred in paragraph 11 of this Regulation: a) verification of the completeness and accuracy of the information contained in documents submitted by the applicant; b) decision to authorize the importation of unregistered medicines or decision to refuse to give such permission with mentioning reasons for rejection; c) issue the applicant a permission for importation of unregistered medicines in the form prescribed by the Commission of the Customs Union, indicating the validity of such permission or notify in writing the refusal to give permission to import unregistered drugs. The fee for the issuance of this permission are not allowed. 13. Resolution of RF MoHSD for the import of unregistered drugs for medical assistance due to of vital indications in individual patient is made in the form of an electronic document, signed by electronic signature. 14. Basis for rejection in permission to import unregistered medicines are: a) the presence of incomplete or false information in documents submitted by the applicant for a permission; b) The prohibition of medical application of drugs in the territory of the Customs Union. 15. Application for a permission to import a specific consignment of unregistered medicines and the results of decision of the Ministry of Health and Social Development of the Russian Federation on this should be recorded in the register of issued permission to import specific consignment of unregistered drugs, decisions to refuse to give such permission, maintained by the Ministry of Health and Social Development of the Russian Federation in approved form. 16. When importing unregistered drugs on the RF territory customs authorities of the RF MoHSD must give permission to import unregistered drugs, except for the importof unregistered medicines on the Russian territory with the status of the goods of the Customs Union.

31. Resolution of the Russian Federation Government N 486 from 30.06.10 AMENDING TO SOME ACTS OF THE GOVERNMENT OF THE RUSSIAN FEDERATION ON ISSUES RELATED TO CIRCULATION OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND THEIR PRECURSORS

32. b) in the list of narcotic drugs and psychotropic substances, which turnover is restricted in the Russian Federation and for which control there are special procedures in accordance with Russian legislation and international treaties of the Russian Federation (List II): To exclude the following drugs from the division “Narcotic Drugs”: “Codeine phosphate”; “Cocaine hydrochloride”; “Morphine hydrochloride”; “Morphine sulfate”; “Ethylmorphine hydrochloride” ...

33. ALSO IN THE SAME DOCUMENT

34. 2. In large and very large amounts of narcotic drugs and psychotropic substances for the purposes of articles 228, 228.1 and 229 of the Penal Code of the Russian Federation, approved by the Government of the Russian Federation on February 7, 2006 N 76 (Laws of the Russian Federation 2006, N 7, ст. 787; N 29, ст. 3253; 2007, N 28, ст. 3439; 2009, N 26, ст. 3183; 2010, N 3, ст. 314):

35. I do not know what it is The only thing I can assume is a large financial interest

36. AT THE SAME TIME Health Minister Golikova reports about decrease in the number of addicts in the country It is clear, because there are fewer formal narcotic drug and those who used it before, ceased to be drug addicts! And as for those who have been in prison for distributing drugs that do not have status of narcotic now?

37. Currently the State Duma is discussing the following issues: Declarative character of licensing of pharmaceutical and medical activities. Up to 500 thousand rubles there is no need to arrange trades, and over 500 thousand rubles - only one INN in lot! In exceptional cases there may be trade names in documents. There is no novel about drug supply in out-patient clinics either in the project of Mandatory Health Insurance, or in the project of basic health care

38. Thus There are significant changes in the drug supply landscape, but it becomes neither better nor understandable We have to hope that laws are separate from practice