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?

Over the past year in the country

The following laws were adopted:The following laws were adopted:• Law on Law on drug circulationdrug circulation• Documents on the pricing of pharmaceuticalsDocuments on the pricing of pharmaceuticals• Government Decree on the import of drugs into the countryGovernment Decree on the import of drugs into the country

PProjectrojectss of the following laws were developed:of the following laws were developed:• On Mandatory Health InsuranceOn Mandatory Health Insurance• New legislation on health careNew legislation on health care• On the licensing of medical and pharmaceutical activitiesOn the licensing of medical and pharmaceutical activities• Amendments toAmendments to the Federal Law # the Federal Law # 94 – 94 – ““law-killerlaw-killer””• And a number of othersAnd a number of others……

All this leads to• Entirely new situation in Entirely new situation in drug supply of citizensdrug supply of citizens

• Unclear prospects for its Unclear prospects for its developmentdevelopment

It should be mentioned• Community of experts and stakeholders Community of experts and stakeholders

accepted all this initiatives negativelyaccepted all this initiatives negatively• Proposals to change projects of documents Proposals to change projects of documents

were accepted aggressively by its were accepted aggressively by its developers developers

• All proposals were not taken into accountAll proposals were not taken into account

Absence of consensus means Absence of consensus means that these documents will not that these documents will not

work!work!

Article 5. Authorityof federal executive bodies in drug circulation (1)

1) 1) holding a unified state policy in drug supply for citizens on the territory of the holding a unified state policy in drug supply for citizens on the territory of the Russian Federation;Russian Federation;

2) 2) approval of the general pharmacopoeial monographs, pharmacopoeial articles, approval of the general pharmacopoeial monographs, pharmacopoeial articles, publication of the State Pharmacopoeiapublication of the State Pharmacopoeia;;

3) 3) sstate control and supervision;tate control and supervision;

4) 4) licensing the production of drugs and pharmaceutical activities in accordance licensing the production of drugs and pharmaceutical activities in accordance with Russian legislationwith Russian legislation;;

5) 5) organization of drug examination, ethical assessment of clinical study of drug organization of drug examination, ethical assessment of clinical study of drug applicationapplication;;

6) 6) grant of permission to carry out clinical trials of drugs, maintaining a register of grant of permission to carry out clinical trials of drugs, maintaining a register of permitions to carry out clinical trials of drugspermitions to carry out clinical trials of drugs;;

7) 7) state registration of drugs, maintaining the state register of medicinesstate registration of drugs, maintaining the state register of medicines;;

8) 8) inspection of compliance of drug production with the rules of production and inspection of compliance of drug production with the rules of production and quality control of drugs, issuing reports about compliance with manufacturer's quality control of drugs, issuing reports about compliance with manufacturer's drug requirements and rules of production and quality control of drugsdrug requirements and rules of production and quality control of drugs;;

Article 5. Authorityof federal executive bodies in drug circulation (2)

state registration of the limit selling prices for vital and essential drugs state registration of the limit selling prices for vital and essential drugs established by manufacturers of drugs and maintenance of the state register of 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 limiting ex-works prices of medicines included in the list of vital and essential drugs;drugs;

10) 10) Establishment the procedure for import of drugs into the territory of the Establishment the procedure for import of drugs into the territory of the Russian Federation and export of drugs from the Russian FederationRussian Federation and export of drugs from the Russian Federation;;

11) 11) establishment of Councils relating drug circulationestablishment of Councils relating drug circulation;;12) certification 12) certification of specialistsof specialists;;13) 13) approval of educational programs for training specialistsapproval of educational programs for training specialists 14) monitoring of 14) monitoring of

drug safety;drug safety;15) participation in international cooperation;15) participation in international cooperation;16) 16) Receiveing information on the establishment and application of the price of Receiveing information on the establishment and application of the price of

drugs and its markup on request of the authorized federal body of executive 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 power from the executive authorities of subjects of the Russian Federation, as well as from subjects of drug circalationwell as from subjects of drug circalation;;

17) 17) application of accountability measures in case of violations of laws of the application of accountability measures in case of violations of laws of the Russian FederationRussian Federation. .

But where is drug supply of But where is drug supply of populationpopulation??

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 participants must be submitted to the MoHSD.

• It is impossible to do it for obvious reasons!

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

BUT BEFORE - APPEAL of the Formulary Committee

from 01.04.10To the President of the Russian Federation

Dmitriy Anatolyevich Medvedevfrom

Vice-Chairman of the FormularyCommittee at the Presidium of the Russian

Academy of Medical Sciences,Professor P.A.Vorobyev

 

On behalf of the RAMS Formulary Committee (FC) call on you to suspend the approval of

the Law "On circulation of drugs" and return it for revision to the State Duma due to lack of major regulations and standards in it, it

would worsen current difficult situation with the drug supply of citizens. FC consistently tried to correct the text of this document at all stages of the law approvement, making it

both through the formal amendment (60) and referring to it’s developers through the

mass media. All proposals were not taken into account.

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.

The appearance of sustainable funding in terms of the state program will lead to the development of domestic analogues (already existing examples -

blood clotting factors, growth hormone, anticancer drugs), and will significantly - in times - reduce the

cost of treatment. The project of federal target program for rare medical technologies, including issues of the sector of domestic pharmaceutical

industry development, developed by the Formulary Committee, approved by the Presidium of the Russian Academy of Medical Sciences and

submitted in the prescribed manner to the Ministry of Economics in autumn 2009. If the new law will not include the issue of rare drugs, further work

on the program is likely to be infertile.

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.

• The major omission of 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.

A short novel on 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. Nowadays physicians and

paramedics are able to sell it legally in their offices, in addition to pharmacies, this

"muddy flow” goes through their hands directly to patients.

The world does not know such items.

There is nothing on the regulation of prescription and over-the-counter

dispensing of pharmaceuticals in 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.

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.

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 FederationIn 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

Regulations for import of drugs for medical application in the territory of the Russian Federation1. 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.

2. 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.

Who can Who can import drugs?import drugs? а) а) organizations – manufactures of pharmaceuticals - for domestic production of organizations – manufactures of pharmaceuticals - for domestic production of drugsdrugs;;

б) б) drug drug wholesale tradewholesale trade organizations organizations;;

в) в) foreign developers of pharmaceuticals and foreign drug manufacturers or other foreign developers of pharmaceuticals and foreign drug manufacturers or other legal entities by order of the developer of pharmaceuticals - to carry out clinical 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 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 register of medicines and quality control of drugs with the permission of the RF MoHSD to import a specific parcel of drugsMoHSD to import a specific parcel of drugs;;

г) г) research organizations, educational institutions of higher education, and drug research organizations, educational institutions of higher education, and drug manufacturers - to develop, research, monitoring safety, quality and effectiveness manufacturers - to develop, research, monitoring safety, quality and effectiveness of the drug with permission of the RF MoHSD to import specific parcel of drugs of the drug with permission of the RF MoHSD to import specific parcel of drugs for medical applicationfor medical application;;

д) д) medical organizations, as well as the organizations referred in paragraphs "a" - medical organizations, as well as the organizations referred in paragraphs "a" - "d" of this paragraph - to provide medical care for vital indications in a "d" of this paragraph - to provide medical care for vital indications in a particular patient with the permission of the RF MoHSD.particular patient with the permission of the RF MoHSD.

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).

6. To obtain conclusion the applicant shall submit to the Rosdravnadzor statement and an electronic copy (in the manner prescribed by the customs legislation of the Customs Union) with the application signed and stamped copies of the applicant the following documents:a) The license of the activity in the sphere of drugs (pharmaceutical activities, the production of medicines);b) 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;a) incorporation and registration documents of the applicant (the statute, the state registration certificate, certificate of registration with the tax authority);d) documents on state registration of each of the imported drugs with the corresponding registration numbers;e) documents on state registration of limiting ex-works prices for imported drugs included in the annually approved by the Government of the Russian Federation a list of vital and essential drugs.

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.

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.

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

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" (in addition to the documents stipulated in points "a", "b" and "c" of paragraph 6 of these Regulations)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;

RememberRemember pp.6.6a) the license of the activity in the sphere of drugs

(pharmaceutical activities, the production of medicines);

b) 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;

c) incorporation and registration documents of the applicant (the statute, the state registration certificate, certificate of registration with the tax authority).

Once again about the novel of unregistered drugs

g) in case of vital indications in individual patient:g) in case of vital indications in individual patient:

Conclusion of council of physicians of federal medical organization, which Conclusion of council of physicians of federal medical organization, which provide medical assistance to a particular patient, signed by the chief provide medical assistance to a particular patient, signed by the chief physician (the director) or a person performing his duties, and an electronic physician (the director) or a person performing his duties, and an electronic copy signed by electronic signature, on the appointment of unregistered drugs 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 to this patient to help due to vital indications and on the necessity of its import;import;

Appeal of the authorized executive body of the subject of the Russian Federation 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 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 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 vital indications in individual patient with a copy of conclusion of council of physicians of federal medical organization, which provide medical assistance physicians of federal medical organization, which provide medical assistance to a particular patient, signed by the chief physician (the director) or a person to a particular patient, signed by the chief physician (the director) or a person performing his duties;performing his duties;

copy of passport or birth certificate of the patient who was appointed an 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) unregistered drug due to vital indications, certified by the federal institution (s) providing medical assistance in the form of an electronic document, signed by providing medical assistance in the form of an electronic document, signed by electronic signature.electronic signature.

There is a feelingthat 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

One can proud of it12. 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 patientof 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.

Resolution of the Russian Federation Government N 486 from 30.06.10

 

AMENDING TO SOME ACTS OF THE GOVERNMENT OF THE RUSSIAN

FEDERATIONON ISSUES RELATED TO

CIRCULATION OF NARCOTIC DRUGS,PSYCHOTROPIC SUBSTANCES AND

THEIR PRECURSORS

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” ...

ALSO IN THE SAME

DOCUMENT

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):

I do not know what it isI do not know what it is

The only thing I can The only thing I can assume is a large assume is a large financial interestfinancial interest

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?

Currently the State Duma is discussing the following issues:

• Declarative character of licensing of Declarative character of licensing of pharmaceutical and medical activities.pharmaceutical and medical activities.

• Up to 500 thousand rubles there is no need to Up to 500 thousand rubles there is no need to arrange trades, and over 500 thousand rubles - arrange trades, and over 500 thousand rubles - only one INN in lot!only one INN in lot!

• In exceptional cases there may be trade names In exceptional cases there may be trade names in documents.in documents.

• There is no novel about drug supply in out-There is no novel about drug supply in out-patient clinics either in the project of Mandatory patient clinics either in the project of Mandatory Health Insurance, or in the project of basic Health Insurance, or in the project of basic health carehealth care

Thus• There are significant changes There are significant changes

in the drug supply landscape, in the drug supply landscape, but it becomes neither better but it becomes neither better

nor understandablenor understandable

• We have to hope that laws We have to hope that laws are separate from practiceare separate from practice