meta peru data disclosure survey (english)

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Peru Assessment of Pharmaceutical Data Disclosure -1- Disclosure Status of Pharmaceutical Sector Data Part of Component 1 of the MeTA Baseline Assessments PERU April 2010 The Medicines Transparency Alliance Peru

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Page 1: MeTA Peru Data Disclosure Survey (English)

Peru Assessment of Pharmaceutical Data Disclosure

-1-

Disclosure Status of Pharmaceutical Sector Data

Part of Component 1 of the MeTA Baseline Assessments

PERU April 2010

The Medicines Transparency Alliance Peru

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DataCollectionTooldevelopedby:

WHOHarvardCollaboratingCenterinPharmaceuticalPolicyOnbehalfof

TheMedicinesTransparencyAlliance

WHOHarvardCollaboratingCenterinPharmaceuticalPolicy

OnbehalfofTheMedicinesTransparencyAlliance

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I. Ways to summarize data disclosure situation

1. Drug registration and quality assurance

1.1 Procedure for obtaining a marketing approval for drugs and status of drug regulatory agency records on all drugs

Sources

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. The MoH Directorate-General of Medical supplies and Drugs (DIGEMID) issues laws, regulations, and directives.

2. Laws dealing with drug registration have been very lax. Up to early 2009, registration only took seven days and the regulatory agency’s tacit authorization (General Health Act, 1997).

3. Procedures are laid out in different legal texts: 1) 1997 Regulations for Pharmaceutical and Similar Product Registration, Control, and Monitoring and their amendments and 2) 2010 DIGEMID administrative procedures.

4. Law 29316, enacted in 2009, amended General Health Act article 50 by dividing drugs into three categories for registration purposes: Category 1) active ingredients found on the national essential drug list, Category 2) active ingredients not found on the national essential drug list but found in the records of a drug regulatory body from one of the twelve countries with high health monitoring standards, and Category 3) active ingredients that do not fall within either category 1 or 2 descriptions. It furthermore amended evaluation periods: from a one month term for category 1 products to a max of one year for category 3 products.

5. There are package insert evaluation and drug stability directives. See Annex 5 to view the entire discussion of point 1.1.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. DIGEMID publishes drug registration standards and procedures on its web site (www.digemid.minsa.gob.pe) and the terms vary according to product category. No information on patented drugs is given.

2. DIGEMID Health Authorization Division is in charge of enforcing registration procedures. 3. There is no DIGEMID division that provides information to companies and users in general

on technical interpretation of the standards. Pre-qualification for files undergoing the drug registration process is not performed.

4. There is the SI-DIGEMID, a data base of valid marketing approvals. See Annex 5 to view the entire discussion of point 1.1.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

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1. In 2009, 26,832 files were presented for obtaining a marketing approval of which 17,219 were processed, leaving 9613.

2. Right now, file evaluation exceeds periods set up by the law. 3. There are 20,584 drugs approved for marketing. 4. Increased communication between DIGEMID and pharmaceutical companies is needed so

technical questions may be answered in time to comply with evaluation periods. This may be accomplished through workshops or a customer service center.

5. DIGEMID-provided drug registration data still cannot be accessed by outside users, so it must improve its digital access..

See Annex 5 to view the entire discussion of point 1.1.

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1.2 Good Manufacturing Practices (GMP) for national and international manufacturers

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. Manufacturers must comply with GMP, and distributors and importers with GWP (Good Warehousing Practices), at which time they receive a certificate to those effects.

2. DIGEMID publishes GMP and GWP on its website. 3. No legal provisions exist for GMP inspections of raw material manufacturers. 4. The 2009 Drug and Medical Equipment Act does provide for the DIGEMID performing GMP

inspections of factories in Peru owned by foreign companies that are not from countries with superior health monitoring standards. This law is not yet being enforced.

See Annex 5 to view the entire discussion of point 1.2.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. DIGEMID’s administrative procedures lay out GMP and GWP certification requirements. 2. DIGEMID is responsible for both certifications. 3. DIGEMID enforces GMP and GWP procedures through inspections, most of these being

unannounced. See Annex 5 to view the entire discussion of point 1.2.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

1. DIGEMID handles its own records on the GMP situation. 2. Barriers depend upon the type of information published. Most information DIGEMID internally

manages. 3. GMP and GWP certificates are used by implementing units to procure drugs using public

funds. See Annex 5 to view the entire discussion of point 1.2.

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1.3 Quality assurance processes in the public and non-profit sectors

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. Laws for these sectors cover a broad area, from granting marketing approval to health control and monitoring in the market.

2. There are no quality assurance laws specific to the non-profit sector, just those that touch upon pharmaceutical establishment operations.

3. For public sector procurement, potential suppliers must be GMP and GWP certified. 4. There are no laws on supplier prequalification regarding standards of quality.

See Annex 5 to view the entire discussion of point 1.3.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. Public sector may purchase drugs using the corporate procurement method for which the DIGEMID draws up technical specifications on the products in question and publishes them per procurement process on the SEACE (State Procurement and Hiring Electronic System) website.

2. Most government warehouses are not GWP certified. 3. Quality assurance procedures fall under SISMED procedures for the MoH public health

service network and therefore are stated in each entity’s procurement rules. See Annex 5 to view the entire discussion of point 1.3.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

1. Technical specifications have been drawn up, but they need to be distributed to implementing units.

2. More technical specifications need to be drawn up. 3. Public procurement information is published on the SEACE web site, but it needs to be

systematized and spread to a wider audience. See Annex 5 to view the entire discussion of point 1.3.

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1.4 Quality assurance data during marketing approval process or sales

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. Drug quality is assured through applying the General Heath Act, its regulations, and GMP and GWP, all of which are published on the DIGEMID web site.

2. The DIGEMID Health Control and Monitoring Division assesses registered drug quality during its sale.

3. Under Law 29316, which amended General Health Act article 50, a new directive concerning Pharmaceutical Product Stability has been issued that establishes much stricter requirements for marketing approvals.

4. No bioavailability and bioequivalence studies on generic drugs are available, but Law 29316 requires their inclusion.

See Annex 5 to view the entire discussion of point 1.4.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. For public drug procurements, technical quality requirements are specified as per the rules of each tender process and are published on the SEACE website. OSCE is the supervisory body.

2. Post-registration, DIGEMID performs inspections on establishments and evaluates drugs to see if they comply with approved quality standards.

See Annex 5 to view the entire discussion of point 1.4.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

1. The DIGEMID Health Control and Monitoring Division publishes the list of products that failed quality control testing on its website.

2. From 2002 to 2006, DIGEMID found that 31% of all brand name drugs and 36% of generic drugs evaluated did not meet quality assurance standards (from a 2008 study performed by Coral titled “Calidad de Productos Farmacéuticos y Afines comercializados en el mercado peruano pesquisados por DIGEMID del 2002 al 2006”)

3. There is no data base of drugs with quality control issues during public procurement processes.

See Annex 5 to view the entire discussion of point 1.4.

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1.5 Routine quality testing and adverse reaction monitoring

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. DIGEMID Health Control and Monitoring Division investigates products on the market and carries out routine quality tests after drugs have been registered. The Access to and Rational Use of Medicine Division Pharmacovigilance Team monitors adverse reactions in registered drugs.

2. Pharmacovigilance and quality control standards are on the books (See Annex 1.5) 3. The National Health Institute’s National Quality Control Center or one of the network’s quality

control labs runs quality control tests. See Annex 5 to view the entire discussion of point 1.5.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. DIGEMID publishes laws concerning quality control investigation and results on its web site. 2. DIGEMID’s Pharmacovigilance Team does not have an official publication covering adverse

reaction monitoring procedures. 3. Adverse reactions are reported voluntarily through what is called the “Hoja Amarilla” (yellow

alert sheet). 4. Peru’s social security network (EsSalud) health centers report adverse reactions to the

regional Pharmacovigilance Committees, which analyze them and then send them on to the Central Pharmacovigilance Committee.

5. The National Police of Peru (PNP) health network writes its own pharmacovigilance reports and sends them to DIGEMID.

See Annex 5 to view the entire discussion of point 1.5.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

4. Up to 2008, DIGEMID’s Pharmacovigilance Team was publishing a pharmacovigilance newsletter.

5. DIGEMID emits warnings and safety reports to inform health care professionals and companies about adverse reactions that need to be included in package inserts.

6. Barriers include 1) voluntary nature of adverse reaction reporting, which translates into there being just a few reports, and 2) information is restricted to certain institutions.

See Annex 5 to view the entire discussion of point 1.5.

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2. Availability of drugs

2.1 Standardized treatment guidelines

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. There are laws that set policies and procedures for drafting and updating the guidelines: MoH resolution 826-2005/MINSA “Procedures for drafting normative documents” and MoH resolution W 422-2005/MINSA, which approved NT 027-MINSA/DGSP-V.01 “Technical standard for drafting clinical practice guidelines”.

2. MoH publishes disseminating procedures for these guidelines on its website (www.minsa.gob.pe).

3. People’s Health Division is responsible for drafting the guidelines. 4. EsSalud statutes on these guidelines are laid out in the General Health Act, Law 27222, and

1997 Supreme Decree 010-97-SA: Regulations on Pharmaceutical and Similar Product Registration, Control, and Health Monitoring and its amendments.

See Annex 6 to view the entire discussion of point 2.1.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. MoH publishes guideline drafting procedures on its website, monitors their quality, and provides technical assistance.

2. MoH has a Standardized Treatment Guideline Committee. 3. EsSalud adapts MoH Standardized Treatment Guidelines to its health service network and

publishes them on its website and intranet portal. 4. Each part of the PNP health service network drafts its own set of guidelines.

See Annex 6 to view the entire discussion of point 2.1.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

1. Barriers include 1) limited number of printed copies for key services and 2) inadequate ongoing distribution to public health services.

2. Promoting their use can be accomplished through 1) ongoing dissemination to the different health services and to the academic world, 2) online course or degree offerings that include recognition of credit hours, and 3) submitting these guidelines to universities for consideration as bibliographic documents for professional and specialist development.

3. EsSalud staff has access to the guidelines.

See Annex 6 to view the entire discussion of point 2.1.

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2.2 Essential drug list

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. January 2010 MoH resolution 062-2010 approved the latest essential drug list that is published on the DIGEMID website.

2. The General Health Act and National Drug Policy (approved through MoH resolution 1240-2004) encourage list updating.

3. Supranational policies, such as the 2009 Andean Drug Policy, incorporate drug selection and their rational use.

4. DIGEMID has developed list updating procedures. 5. EsSalud has had such a list since 2006, and it is available on its website

(www.essalud.gob.pe). See Annex 6 to view the entire discussion of point 2.2.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. DIGEMID Access to and Rational Use of Medicine Division encourages list use. See Annex 6 to view the entire discussion of point 2.2.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

1. Barriers include lack of health professional training on rational use and selection of drugs. 2. Promoting list use requires providing technical assistance to health service’s

pharmacological committees, drafting complementary material for promoting adherence to the lists, and ongoing supervision and control.

See Annex 6 to view the entire discussion of point 2.2.

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2.3 Pharmaceutical patents in Peru

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. The INDECOPI (National Institute for the Defense of Competition and Protection of Intellectual Property) is in charge of regulating Peruvian patent policy.

2. Related laws include: 1) Andean Community Decision 468, 2) Paris Convention for the Protection of Industrial Property, and 3) Legislative Decree 1075 approving Decision 486 complementary provisions.

3. The INDECOPI publishes laws that deal with patents on its website (www.indecopi.gob.pe). 4. A 5 year test data protection period has been incorporated into pharmaceutical regulation

since passage of the U.S. – Peru FTA. 5. Peru is a signatory of the WTO’s TRIPS agreement. 6. Provisions in the Peruvian Constitution, Civil Code, Penal Code, General Administrative

Procedures Act, and Contentious Administrative Proceedings Act also deal with this matter. See Annex 6 to view the entire discussion of point 2.3.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. The INDECOPI Inventions and New Technologies Division has produced procedures for intellectual property and pharmaceutical patent registration, all of which are available to the public.

2. Annex 6 lists URL’s that take you to INDECOPI patent information pages. See Annex 6 to view the entire discussion of point 2.3.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

1. Neither the INDECOPI nor DIGEMID (since it has no jurisdiction) has a publically accessible data base that provides information on the status of pharmaceutical patents.

2. The INDECOPI and DIGEMID are neither connected administratively nor do they share information when it comes to pharmaceutical patents.

3. Interested parties must pay for patent status data, the amount having been established in the INDECOPI’s administrative procedures.

4. Information flow between the INDECOPI and DIGEMID needs to be set up. See Annex 6 to view the entire discussion of point 2.3.

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2.4 Public and non-profit sector procured drug volume and value

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. Most important law dealing with public drug procurement is the State Hiring and Procurement Act and its regulations.

2. OSCE (Government Contracts Supervisory Agency) is the governing body. 3. Law 27806 is the Transparency and Public Access to Information Act. 4. No law obliges publication of drug procurement budgets for either sector.

See Annex 6 to view the entire discussion of point 2.4.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. OSCE and SEACE publish the annual procurement plan per government agency on their websites.

2. MoH publishes its list of drugs to be purchased on the DIGEMID website. 3. PNP health services internally manage this information.

See Annex 6 to view the entire discussion of point 2.4.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

1. No exact 2010 drug procurement budget information was available because there is no central agency that systematizes it.

2. Certain public agencies internally manage the information. 3. Non-profit sector only handles information internally. 4. MoH manages information on the volume of purchased drugs through SEACE and its own

data, which is made available on both organizations’ websites. 5. A proper virtual platform needs to be created and relations with the Ministry of the Economy

and Finances to be initiated. See Annex 6 to view the entire discussion of point 2.4.

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2.5 Private sector supplied drug volume and value

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. Current law does not require private sector disclosure of its supplied drug volume and value information.

See Annex 6 to view the entire discussion of point 2.5.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. IMS handles data on imported, manufactured, or sold drug volume and value (broken down by region, therapeutic category, or supply system level).

See Annex 6 to view the entire discussion of point 2.5.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

1. IMS provides data on private sector purchased drug volumes. 2. IMS information is expensive so only pharmaceutical companies buy it. 3. Private sector information is difficult to access since it is confidential and restricted. 4. Barriers include 1) lack of legal obligations for the private sector to divulge information on its

drug volume and value, 2) IMS being the exclusive source for this information, 3) elevated information cost, and 4) lack of any available information.

5. Promoting its use requires 1) amendments to legislation and 2) effective partnerships with the Peruvian Drug Price Observatory so pricing information can be published.

See Annex 6 to view the entire discussion of point 2.5.

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2.6 Availability of drugs for consumers

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. Provisions in these laws cover availability of drugs: 1) General Health Act, 2) National Drug Policy, and 3) SISMED Directive (MoH resolution # 1753-2002-SA/DM) which approves the integrated drug and surgical equipment supply system – SISMED) plus its most recent amendment through MoH resolution #367-2005 on availability of drugs and other matters.

2. There are other related laws: Comprehensive Health Insurance Act and Universal Health Care Coverage Act.

3. The law does not discuss non-profit sector. See Annex 6 to view the entire discussion of point 2.6.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. DIGEMID publishes laws on its website. 2. MoH is informed on important drug stocks through the DISA’s (Department of Health) and

the DIRESA’s (Regional Department of Health) distribution network. See Annex 6 to view the entire discussion of point 2.6.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

1. DIGEMID publishes availability information by region and by drug on the web page “Sala de Situación de Acceso a Medicamentos” (Drug Access Situation Room); data is mapped by a geo-referencing system that includes all health establishments.

2. In 2008, the public sector began implementing the WHO/HAI drug price surveying method, after its adaptation to Peru.

3. No private sector essential drug data is known since it does not have to provide it. 4. Promoting its use requires 1) informing a wider audience of the Observatory, 2) constructing

drug access situation room website for each DIRESA, and 3) drafting and distributing newletters.

See Annex 6 to view the entire discussion of point 2.6.

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2.7 Routine audits of public, private, and non-profit sector POS

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. The DIGEMID Health Control and Monitoring Division is responsible for auditing pharmacies and warehouses for all three sectors.

2. Related laws include: General Health Act, Law 29316, Supreme Decree 021-2001-SA: Pharmaceutical Establishment Regulations, and Supreme Decree 010-97-SA: Regulations on Pharmaceutical and Similar Product Registration, Control, and Monitoring.

3. Other standards include GWP, GDP (Good Distribution Practices), and inspection guidelines for pharmaceutical and similar product warehouses and distribution centers.

4. All the above are available on the DIGEMID website. See Annex 6 to view the entire discussion of point 2.7.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. Pharmacy audits are performed by the DISA’s in Lima and respective DIRESA’s across the country.

2. Pharmaceutical wholesaler audits are performed by DIGEMID to verify GWP compliance. 3. DIGEMID only has jurisdiction over Lima-based government warehouses.

See Annex 6 to view the entire discussion of point 2.7.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

1. DIGEMID manages a GWP compliance database with information of inspections and audits. 2. Primary barrier is that inspection results are restricted.

See Annex 6 to view the entire discussion of point 2.7.

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3. Drug prices

3.1 Drug prices for consumers and distributors in the public, private, and non-profit sectors

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. Private and non-profit sector final consumer prices are not regulated. 2. Drug prices for MoH hospitals and health centers are thus regulated: prices under the

corporate procurement method are set at a maximum of 25% of the purchase cost as laid out by the SISMED and MoH resolutions 1753-2002/MINSA and 367-2005/MINSA. DIGEMID makes price list public.

3. Nov. 25, 2009 Law 29459 establishes that economically priced drugs are essential for universal access to them, so it provides for implementation of a drug price information system (still in the works).

4. Jan. 17, 2010 MoH resolution 040-2010/MINSA orders that public and private establishments shall set up a drug price information system.

5. Above laws are available on the DIGEMID website. See Annex 7 to view the entire discussion of point 3.1.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. DIGEMID web site will be the host for the Drug Price Observatory. 2. MoH resolution1753-2002/MINSA (found on the DIGEMID website) provides public sector

drug pricing procedures. 3. SISMED monitors public sector prices, while IMS data covers the private sector. 4. Of the three sectors, only the public makes its final prices available. 5. The DIGEMID Access to and Rational Use of Drugs Division performed a study on access to

drugs. See Annex 7 to view the entire discussion of point 3.1.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

1. The Comprehenisve Health Insurance Plan publishes its drug prices on its web site. 2. Barriers include 1) non-dissemination of prices and 2) computer illiteracy. 3. Promoting its use requires 1) improved communication strategies, 2) cultural adaptation, and

3) user empowerment vis-à-vis their right to access to drugs. 4. Pharmacies, the establishment where most people purchase their drugs, are not open to

providing drug prices. This is being dealt with as the observatory is being set up. 5. The magazine, Kairos, supplies prices of private sector products on sale in pharmacies, but

problems include 1) data not being differentiated by market segment or region, 2) no regard being given to each establishment’s economy of scale, and 3) private sector failure to update and to spread its pricing information.

6. The non-profit sector does have a price list.

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See Annex 7 to view the entire discussion of point 3.1.

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3.2 Public sector drug procurement

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. Procurement procedures are laid out in the State Procurement and Hiring Act available on the SEACE and OSCE websites.

2. OSCE is in charge of monitoring government procurements. 3. EsSalud, PNP, and Armed Forces health services do not have specific price policy laws.

See Annex 7 to view the entire discussion of point 3.2.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. SEACE publishes government procurement data on its website (www.osce.gob.pe). 2. The observatory is under construction in the DIGEMID web site.

See Annex 7 to view the entire discussion of point 3.2.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

1. Government drug procurement price information is being transferred to the observatory. 2. EsSalud procurement price information is not publicly available. 3. Barriers include Internet illiteracy. 4. Promoting its use requires 1) more accessible and user friendly tools and 2) a DIGEMID drug

price database that the soon to be operational Price Observatory will manage. 5. Additional information on different governmental agency procurement processes and their

audit results are also needed. See Annex 7 to view the entire discussion of point 3.2.

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3.3 Drug price components in the public, private, and non-profit sectors

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. No law regulates drug price increases in any of the three sectors. 2. MoH prices are regulated by the SISMED. 3. Antiretroviral, cancer, and diabetes drugs are sales tax and tariff free, according to current

legislation. See Annex 7 to view the entire discussion of point 3.3.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. DIGEMID performs no audits on margins for the drug supply chain. 2. There is no data price components (taxes, rates, margins, and other charges) for the primary

essential drugs, whether produced in or outside of Peru (by region, sector, care level, and therapeutic class).

3. EsSalud relies on its own internal controls. See Annex 7 to view the entire discussion of point 3.3.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

1. DIGEMID has not researched WHO/HAI price components. 2. Public sector barriers include 1) zero systematization, 2) incomplete data disclosure, 3)

product confidentiality, 4) marketing chain, and 5) no trustworthy and transparent data. 3. Even though EsSalud is part of the public sector, price component data is unavailable. 4. Primary private sector barrier is data confidentiality. 5. Promoting its use requires 1) making the observatory operational, 2) having viable

technology, and 3) empowering patients. 6. While 200 cancer drugs are sales tax and tariff free, this had no effect on lowering the final

price (from the study “Evaluación de los Potenciales Efectos sobre Acceso a Medicamentos del Tratado de Libre Comercio que se negocia con los Estados Unidos de América” by Valladares & col., 2005).

See Annex 7 to view the entire discussion of point 3.3.

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4. Drug Promotion

4.1 Industry practices, regulations, and policies for drug promotion

Sources:

Policy: Are there any laws/ policies? Are they published? Are there any related regulations?

1. No law or regulation directly addresses drug promotion and advertising control, yet dispositions imbedded in some health-related laws do touch upon the matter. (See Annex 4.1).

2. November 25, 2009 Law 29459 includes a chapter with four articles on promotion and advertising, yet its entrance into force is pending.

3. DIGEMID publishes related legislation on its web page.

See Annex 8 for full discussion of point 4.1.

Practice: Are procedures published? How are they enforced? What data exists? Who has access to it?

1. The DIGEMID Advertising Control Team inspects drug ads for compliance with current legislation.

2. INDECOPI applies penalties according to DIGEMID’s claims of violations of said laws. 3. The DIGEMID website contains these pages: a) Advertisement Quality Observatory

(updated on April 2007), b) list of approved ads (updated to date), and c) INDECOPI’s list of actions and penalties for advertising infractions (updated to 2007).

See Annex 8 for full discussion of point 4.1.

Results: What data is available? Who uses it? List barriers to using it. What can be done to promote its wider use?

1. Laws are available to the public, but DIGEMID’s only lists current approved ads on its website.

2. The Peruvian Consumers Association (ASPEC) and Peruvian Pharmaceutical Society for Regulatory Affairs (SOPAFAR) are the only organizations that have requested this data.

3. Barriers include a) information location, b) lack of updated information, c) lack of published grounds for non-compliance, and d) DIGEMID can only report infractions since the INDECOPI has jurisdiction for issuing resolutions.

4. DIGEMID and INDECOPI should coordinate more closely. Regulatory agencies, civil society, pharmaceutical industry associations, and the academic community should share information and provide more training in order to inform more widely on ethics in drugs advertising and on current national and international legislation.

See Annex 8 for full discussion of point 4.1.

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ANNEXES: ANNEX 4.1

DRUG ADVERTISING-RELATED LEGISLATION 1. General Health Act articles 69 – 72 (Law 26842 – July 20, 1997)

2. Ministry of Health Law (27657 – January 29, 1992)

3. Supreme Decree 010-97/SA: Regulations on Pharmaceutical and Similar Product

Registration, Control, and Monitoring (December 24, 1997)

4. Supreme Decree 023-2005/SA article 55, a, f, g, i, l, and m (Regulations for Ministry

of Health Organization and Functions)

5. Legislative Decree 691-91-INDECOPI article 29 and its amendment, Legislative

Decree 807-96

6. Supreme Decree 023-2001/SA: Regulations for Narcotic Drugs, Psychotropic

Substances, and Others Subject to Supervision and Control

7. Law 29459: Pharmaceutical Products, Medical Devices, and Health Products Act.

Chapter X. (November 25, 2009)

ANNEX 1.5

QUALITY CONTROL AND ADVERSE REACTIONS MONITORING LAWS 1. General Health Act articles 69 – 72

2. Supreme Decree 010-97/SA: Regulations on Pharmaceutical and Similar Product

Registration, Control, and Monitoring

3. Supreme Decree 018-2001/SA

4. Supreme Decree 021-2001/SA. Regulations for Pharmaceutical Establishments

5. Ministry of Health Resolution 502-98-SA/DM

6. Ministry of Health 239-99-SA/DM

7. Ministry of Health 431-2001-SA/DM

8. DIGEMID Director’s Resolution 354-99-DG-DIGEMID on establishing a Peruvian

Pharmacovigilance System

9. DIGEMID Director’s Resolution 993-99-DG-DIGEMID

10. DIGEMID Director’s Resolution 813-2000-DG-DIGEMID

11. Law 29459: Pharmaceutical Products, Medical Devices, and Health Products Act.

Chapter X.

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Peru Assessment of Pharmaceutical Data Disclosure

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ANNEX 5

AREA 1: DRUG REGISTRATION AND QUALITY ASSURANCE

ANNEX 6

AREA 2: AVAILABILITY OF DRUGS

ANNEX 7

AREA 4: DRUG PRICES

ANNEX 8

AREA 4: DRUG PROMOTION