Switzerland

PHARMACEUTICAL COUNTRY PROFILE

ii

Switzerland

Pharmaceutical Country Profile Published by the Swiss Federal Office of Public Health in collaboration with the

World Health Organization

September 2011

Any part of this document may be freely reviewed, quoted, reproduced, or translated in full or in part, provided that the source is acknowledged. It may not be sold, or used in

conjunction with commercial purposes or for profit.

This document was produced with the support of the World Health Organization (WHO) Switzerland Country Office, and all reasonable precautions have been taken to verify the

information contained herein. The published material does not imply the expression of any opinion whatsoever on the part of the World Health Organization, and is being distributed

without any warranty of any kind – either expressed or implied. The responsibility for interpretation and use of the material lies with the reader. In no event shall the World Health

Organization be liable for damages arising from its use.

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Foreword

The 2011 Pharmaceutical Country Profile for Switzerland has been produced by

the Swiss Federal Office of Public Health, in collaboration with the World Health

Organization.

This document contains information on existing socio-economic and health-

related conditions, resources; as well as on regulatory structures, processes and

outcomes relating to the pharmaceutical sector in Switzerland. The sources of

data for each piece of information are presented in the tables that can be found

at the end of this document.

On behalf of the Swiss Federal Office of Public Health, I wish to express my

appreciation to Alexandre von Kessel from the Swiss Federal Office of Public

Health for his contribution to the process of data collection and the development

of this profile.

It is my hope that partners, researchers, policy-makers and all those who are

interested in the Switzerland pharmaceutical sector will find this profile a useful

tool to aid their activities.

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Table of Contents

Foreword .......................................................................................................... iii

Table of content ................................................................................................... iii

Introduction ...........................................................................................................1

Section 1 - Health and Demographic Data ........................................................3

Section 2 - Health Services ................................................................................5

Section 3 - Policy Issues ....................................................................................8

Section 4 – Medicines Trade and Production.................................................11

Section 5 – Medicines Regulation ...................................................................13

Section 6 - Medicines Financing......................................................................20

Section 7 - Pharmaceutical procurement and distribution in the public

sector ..............................................................................................25

Section 8 - Selection and rational use of medicines......................................26

Section 9 - Household data/access .................................................................28

1

Introduction

This Pharmaceutical Country Profile provides data on existing socio-economic

and health-related conditions, resources, regulatory structures, processes and

outcomes relating to the pharmaceutical sector of Switzerland. The aim of this

document is to compile all relevant, existing information on the pharmaceutical

sector and make it available to the public in a user-friendly format. In 2010, the

country profiles project was piloted in 13 countries

(http://www.who.int/medicines/areas/coordination/coordination_assessment/en/in

dex.html). During 2011, the World Health Organization has supported all WHO

Member States to develop similar comprehensive pharmaceutical country

profiles.

The information is categorized in 9 sections, namely: (1) Health and

Demographic data, (2) Health Services, (3) Policy Issues, (4) Medicines Trade

and Production (5) Medicines Regulation, (6) Medicines Financing, (7)

Pharmaceutical procurement and distribution, (8) Selection and rational use, and

(9) Household data/access. The indicators have been divided into two categories,

namely "core" (most important) and "supplementary" (useful if available). This

narrative profile is based on data derived from both the core and supplementary

indicators. The tables in the annexes also present all data collected for each of

the indicators in the original survey form. For each piece of information, the year

and source of the data are indicated; these have been used to build the

references in the profile and are also indicated in the tables. If key national

documents are available on-line, links have been provided to the source

documents so that users can easily access these documents.

The selection of indicators for the profiles has involved all technical units working

in the Essential Medicines Department of the World Health Organization (WHO),

as well as experts from WHO Regional and Country Offices, Harvard Medical

School, Oswaldo Cruz Foundation (known as Fiocruz), University of Utrecht, the

Austrian Federal Institute for Health Care and representatives from 13 pilot

2

countries. The compiled data comes from international sources (e.g. the World

Health Statistics1,2), surveys conducted in the previous years and country level

information collected in 2011.

Data collection in all 193 member states has been conducted using a user-

friendly electronic questionnaire that included a comprehensive instruction

manual and glossary. Countries were requested not to conduct any additional

surveys, but only to enter the results from previous surveys and to provide

centrally available information. To facilitate the work of national counterparts, the

questionnaires were pre-filled at WHO HQ using all publicly-available data and

before being sent out to each country by the WHO Regional Office. A coordinator

was nominated for each of the member states. The coordinator for Switzerland

was Alexandre von Kessel. More information about the Pharmaceutical Country

Profile is available on WHO web site at:

http://www.who.int/medicines/areas/coordination/coordination_assessment/en/in

dex.html.

The completed questionnaires were then used to generate individual country

profiles. In order to do this in a structured and efficient manner, a text template

was developed. Experts from member states took part in the development of the

profile and, once the final document was ready, an officer from the Swiss Federal

Office of Public Health certified the quality of the information and gave formal

permission to publish the profile on the WHO web site.

3

Section 1 - Health and Demographic Data

This section gives an overview of the demographics and health status of

Switzerland.

1.1 Demographics and Socioeconomic Indicators

The total population of Switzerland in 2008 was 7,541,000 with an annual

population growth rate of 0.6%1,3. The annual GDP growth rate is 1.78%4. The

2009 GDP per capita was US$ 63,535 (at the current exchange ratei)3. Sixteen

percent (16%) of the population is under 15 years of age, and 23% of the

population is over 60 years of age. The urban population currently stands at 73%

or the total population. The fertility rate in Switzerland is1.5 births per woman.

The income share held by the lowest 20% of the population is 7.55% (as a % of

national income). The adult literacy rate for the population over 15 years is 99%.

1.2 Mortality and Causes of Death

The life expectancy at birth is 80 and 84 years for men and women, respectively.

The infant mortality rate (i.e. children under 1 year) is 4/1,000 live births. For

children under the age of 5, the mortality rate is 5/1,000 live births. The maternal

mortality rate is 5/100,000 live births1.

The top 10 diseases causing mortality in Switzerland are

[World Health Organization, "Mortality Country Fact Sheet, 2006: Switzerland",

http://www.who.int/whosis/mort/profiles/mort_euro_che_switzerland.pdf]:

Disease Deaths (000) % of deaths

1 Ischaemic heart disease 10 18%

2 Cerebrovascular disease 4 7

3 Trachea, bronchus, lung cancers 2 5

4 Alzheimer and other dementias 2 5

i The exchange rate for calculation for NCU is 1.08, which is consistent with the timing of the collection of related NHA data.

4

5 Lower respiratory infections 2 4

6 Chronic obstructive pulmonary

disease 1 3

7 Diabetes mellitus 1 3

8 Colon and rectum cancers 1 3

9 Prostate cancer 1 3

10 Hypertensive heart disease 1 2

The adult mortality rate for both sexes between 15 and 60 years is 60 / 1,000

population, while the neonatal mortality rate is 3 / 1,000 life births. The age-

standardized mortality rate by non-communicable diseases is 360 / 100,000

population.

5

Section 2 - Health Services

This section provides information regarding health expenditures and human

resources for health in Switzerland. The contribution of the public and private

sector to overall health expenditure is shown. Data on human resources for

health is limited for Switzerland, and data for the pharmaceutical sector is not

available.

2.1 Health Expenditures

In Switzerland, the total annual expenditure on health (THE) in 2008 was 57,071

million CHF (US$ 52,844 million)5. The total annual health expenditure was

10.7% of the GDP. The total annual expenditure on health per capita was 7,568

CHF (US$ 7,007)6.

The general governmentii health expenditure (GGHE) in 2008, as reflected in the

national health accounts (NHA), was 33,648 CHF (US$ 31,156). This

government spending represents 58.9% of the total expenditure on health in

Switzerland, with a total annual per capita public expenditure on health of 4,462

CHF (US$ 4,131). The government annual expenditure on health represents

19.8% of the total government budget. Private health expenditure covers the

remaining 41% of the total health spending.

Of the total population, 100% is covered by a public health service, public health

insurance or social insurance, or other sickness funds, and 29.5% is covered by

a private health insurance. Social security expenditure makes up 72.15% of

government expenditure on health. The annual growth rate of total

pharmaceutical market value is 4.9%.

ii According to the NHA definition, by "government expenditure" means all expenditure from public

sources, like central government, local government, public insurance funds and parastatal companies.

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Private out-of-pocket expenditure as percent of private health expenditure is

75.04%. Premiums for private prepaid health plans are 22.59% of total private

health expenditure.

2.2 Health Personnel and Infrastructure

The health workforce is described below in Table 1 and Figure 1.

In Switzerland, there are 4,269 (5.6 /10,000 population) licensed pharmacists,

30,166 (38.2 /10,000 population) physicians and 81,754 (105 /10,000 population)

nursing and midwifery personnel in Switzerland1. The ratio of doctors to

pharmacists is 7.1.

Table 1: Human resources for health in Switzerland

Human Resources Number (per 10,000

population)

Licensed pharmacists (all sectors) 4,269 (5.6 /10,000)1

Physicians (all sectors) 30,166 (38.2 /10,000)1

Nursing and midwifery personnel (all sectors)

81,754 (104.9 /10,000)1

Figure 1: The density of the Health Workforce 2009 in Switzerland (all

sectors)

105

38

6

0 20 40 60 80 100 120

Nursing and

Midwife Personnel

Physicians

Pharmacists

Per 10,000 Population

Source: World Health Organization (WHO), World Health Statistics 2010

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In Switzerland, a strategic plan for pharmaceutical human resource development

is not in place7.

The health facility structure is described in the table below and in Table 2. In total,

there are 313 hospitals and 1731 licensed pharmacies in Switzerland.

Table 2: Health centre and hospital statistics

Infrastructure Number (2009)

Hospitals 3138

Hospital beds (per 10,000 population) 551

Licensed pharmacies 1,7318

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Section 3 - Policy Issues

This section addresses the main characteristics of the pharmaceutical policy in

Switzerland. The many components of a national pharmaceutical policy are taken

from the WHO publication “How to develop and implement national drug policy”

(http://apps.who.int/medicinedocs/en/d/Js2283e/). Information about the capacity

for manufacturing medicines and the legal provisions governing patents is also

provided.

3.1 Policy Framework

In Switzerland, a National Health Policy does not exist7, nor does an associated

National Health Policy implementation plan7. The cantons are competent for

healthcare in Switzerland and a non binding national dialog exists between

Confederation and cantons on health policy. A national strategy for better quality

in the health sector was also adopted by the Swiss Federal Council in 2009 and

current discussion focuses on activities and provisions for implementation of this

strategy.

An official National Medicines Policy (NMP) document exists in Switzerland9 and

was updated in 2007. A NMP implementation plan also exists and was most

recently updated in 20079.

Policies regarding pharmaceuticals exist, as detailed in Table 3. Pharmaceutical

policy implementation is regularly monitored/assessed by the Swiss Federal

Office of Public Health, Section Evaluation and Section for Pharmaceutical

Products Law.

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Table 3: Scope of the Switzerland NMP9

Aspect of policy Covered

Selection of essential medicines No

Medicines financing Yes

Medicines pricing Yes

Medicines Procurement Yes

Medicines Distribution Yes

Medicines Regulation Yes

Pharmacovigilance Yes

Rational use of medicines --

Human Resource Development Yes

Research Yes

Monitoring and evaluation Yes

Traditional Medicine --

A policy relating to clinical laboratories exists and was updated in 19967. An

associated National clinical laboratory policy implementation plan, developed in

1996, also exists7. Access to essential medicines/technologies as part of the

fulfillment of the right to health, is not recognized in the constitution or national

legislation as the EML is not relevant in Switzerland. However, more than 2,500

medicines are on the reimbursement list of the pharmaceutical specialties7.

There is not a national good governance policy in Switzerland7. The Federal

Department of Home Affairs (FDHA), Federal Office of Public Health (FOPH),

and Swissmedic are the agencies responsible for oversight in Switzerland.

A policy is not in place to manage and sanction conflict of interest issues in

pharmaceutical affairs. There is a formal code of conduct for public officials

regarding conflicts of interests

(http://intranet.infopers.admin.ch/arbeitgeber/01212/index.html?lang=fr&amtid=2).

However there is no whistle-blowing mechanism that allows individuals to raise

concerns about wrongdoing occurring in the pharmaceutical sector of

Switzerland7. Although there is a Regulatory Authority for the authorization of

pharmaceutical products on the national level, due to the distinct federalism in

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Switzerland, the use and distribution of pharmaceutical products is predominantly

in the competence of the cantons.

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Section 4 – Medicines Trade and Production

4.1 Intellectual Property Laws and Medicines

Switzerland is a member of the World Trade Organization10. Legal provisions for

granting patents to manufacturers exist and cover pharmaceuticals, medical

supplies, and medical equipment.

Intellectual Property Rights are managed and enforced by the Swiss Federal

Institut of Intellectual Property [www.ige.ch]7.

National Legislation has been modified to implement the TRIPS Agreement and

contains TRIPS-specific flexibilities and safeguards11, presented in Table 4.

Switzerland is not eligible for the transitional period to 2016.

Table 4: TRIPS flexibilities and safeguards are present in the national law

Flexibility and safeguards Included

Compulsory licensing provisions that can be applied for reasons of public health

Yes

Bolar exceptionsiii Yes

Parallel importing provisions Yes

The country is engaged in capacity-strengthening initiatives regarding Intellectual

Property Rights in order to contribute, inter alia, to innovation and promote public

health, for the benefit of the overall sustainable socio-economic development of

the countries concerned.

iii Many countries use this provision of the TRIPS Agreement to advance science and technology. They

allow researchers to use a patented invention for research, in order to understand the invention more fully. In addition, some countries allow manufacturers of generic drugs to use the patented invention to obtain marketing approval (for example from public health authorities) without the patent owner’s permission and before the patent protection expires. The generic producers can then market their versions as soon as the patent expires. This provision is sometimes called the “regulatory exception” or “Bolar” provision. Article 30 This has been upheld as conforming with the TRIPS Agreement in a WTO dispute ruling. In its report adopted on 7 April 2000, a WTO dispute settlement panel said Canadian law conforms with the TRIPS Agreement in allowing manufacturers to do this. (The case was titled “Canada - Patent Protection for Pharmaceutical Products”) [In: WTO OMC Fact sheet: TRIPS and pharmaceutical patents, can be found on line at: http://www.wto.org/english/tratop_e/trips_e/tripsfactsheet_pharma_2006_e.pdf]

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4.2 Manufacturing

There are 468 licensed pharmaceutical manufacturers in Switzerland.

Manufacturing capabilities are presented in Table 5 below.

Table 5: Switzerland manufacturing capabilities7

Manufacturing capabilities

Research and Development for discovering new active substances

Yes

Production of pharmaceutical starting materials (APIs) Yes

The production of formulations from pharmaceutical starting material

Yes

The repackaging of finished dosage forms Yes

There are 468 manufacturers that are Good Manufacturing Practice (GMP)

certified.

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Section 5 – Medicines Regulation

This section details the pharmaceutical regulatory framework, resources,

governing institutions and practices in Switzerland.

5.1 Regulatory Framework

In Switzerland, there are legal provisions establishing the powers and

responsibilities of the Medicines Regulatory Authority (MRA). The MRA is

Swissmedic, the Swiss Agency for Therapeutic Products. Refer to Table 6 for

details. The MRA has its own website, which can be found at this URL:

www.swissmedic.ch/index.html?lang=en

Table 6: Functions of the Switzerland National MRA12

Function

Marketing authorisation / registration Yes

Inspection Yes

Import control Yes

Licensing Yes

Market control Yes

Quality control Yes

Medicines advertising and promotion Yes

Clinical trials control Yes

Pharmacovigilance Yes

Other: Surveillance of Medical Devices Legal Prosecution

Yes Yes

As of 2011, there were 325 permanent staff (Full Time Equivalents, FTE) working

for the MRA. The MRA is involved in harmonization/collaboration initiatives as

Swissmedic's 2011-2014 mandate states that it works with international

authorities on areas for which it is responsible and, if appropriate, collaborates on

national and international projects as long as these contribute towards fulfilling its

legal mandate or the service agreement.

14

Funding for the MRA comes from fees for procedures, fees on sales prices and

governmental contribution. The Regulatory Authority retains revenues derived

from regulatory activities. Swissmedic utilizes a computerized information

management system to store and retrieve information on processes that include

registrations, inspection, etc7.

5.2 Marketing Authorization (Registration)

In Switzerland, legal provisions require marketing authorization (registration) for

all pharmaceutical products on the market, however exceptions/waivers for

registration do exist9,13. Mutual recognitions mechanisms are in place as

specified in Article 13 of the Law on Therapeutic Products14. Explicit and publicly

available criteria exist for assessing applications for marketing authorization of

pharmaceutical products14. In 2011, there were 7,500 pharmaceutical products

registered in Switzerland. There are legal provisions requiring the MRA to make

the list of registered pharmaceutical products publicly available and update it

regularly. The updated list can be accessed through http://www.swissmedic.ch.

Medicines are always registered by their INN (International Non-proprietary

Names) or Brand name + INN. Legal provisions require a fee to be paid for

Medicines Market Authorization (registration) based on applications14.

5.3 Regulatory Inspection

In Switzerland, legal provisions exist allowing for appointment of government

pharmaceutical inspectors14. Legal provisions exist permitting inspectors to

inspect premises where pharmaceutical activities are performed, such

inspections are required by law and are a pre-requisite for the licensing of public

and private facilities14. Where inspections are legal requirements, these are the

same for public and private facilities14. Inspections are carried out on a number of

entities, outlined in Table 7.

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Table 7: Local entities inspected for GMP compliance14

Entity Inspection Frequency

Local manufacturers Yes Every 2-3 years

Private wholesalers Yes Every 2-3 years

Retail distributors Yes --

Public pharmacies and stores Yes --

Pharmacies and dispensing points if health facilities

Yes --

5.4 Import Control

Legal provisions require authorization to import medicines. Laws exist that allow

the sampling of imported products for testing. Legal provisions also require

importation of medicines through authorized ports of entry. Regulations or laws

allow for inspection of imported pharmaceutical products at authorized ports of

entry14.

5.5 Licensing

In Switzerland, legal provisions require manufacturers to be licensed14. Legal

provisions also require manufacturers (both domestic and international) to

comply with Good Manufacturing Practices (GMP) that are published by the

government14.

Legal provisions require importers, wholesalers and distributers to be licensed14.

Additionally, legal provisions require wholesalers and distributors to comply with

Good Distributing Practices (see Table 8).

Table 8: Legal provisions pertaining to licensing14

Entity requiring licensing

Importers Yes

Wholesalers Yes

Distributors Yes

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Good Distribution Practices are published by the government14. Legal provisions

require pharmacists to be registered. Legal provisions also require both private

and public pharmacies to be licensed14. By law, a list of all licensed

pharmaceutical facilities is required to be published.

5.6 Market Control and Quality Control

In Switzerland, legal provisions exist for controlling the pharmaceutical market14.

A laboratory for Quality Control testing exists in Switzerland and is a functional

part of the MRA14. Services are also contracted to other Official Medicines

Control Laboratories (OMCLs) and to the private service providers as needed.

However, less than 1% of the total workload is outsourced.

Existing national laboratory facilities have been accepted for collaboration with

the WHO pre-qualification Programme, including TSA for MMR, OPV, Rubella

and Yellow Fever7.

Medicines are tested for a number of reasons, summarized in Table 9.

Table 9: Reason for medicines testing7

Medicines tested:

For quality monitoring in the public sectoriv --

For quality monitoring in the private sectorv Yes

When there are complaints or problem reports Yes

For product registration Yes

For public procurement prequalification Yes

For public program products prior to acceptance and/or distribution

Yes

Samples are collected by government inspectors for undertaking post-marketing

surveillance testing7. In the past 2 years, 1679 samples were taken for quality

iv Routine sampling in pharmacy stores and health facilities

v Routine sampling in retail outlets

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control testing. Of the samples tested, 149 (or 8.8%) failed to meet the quality

standards. The results are publicly available14.

5.7 Medicines Advertising and Promotion

In Switzerland, legal provisions exist to control the promotion and/or advertising

of medicines. The Federal Act on Therapeutic Products and the ordinance for

advertising of medicinal products constitute the legal base. Swissmedic is

responsible for the control of medicines incl. thepromotion and/or advertising of

medicines. Details on legislation governing therapeutic products in Switzerland

can be found here:

http://www.swissmedic.ch/rechtstexte/00201/00203/index.html?lang=en.

Legal provisions prohibit direct advertising of prescription medicines to the public.

Pre-approval for medicines advertisements and promotional materials is required

for electronic media (TV, radio) and defined groups of drugs (including sedatives,

analgetics, laxatives, anorexics, somnifers). Guidelines and Regulations exist for

advertising and promotion of non-prescription medicines. There is a national

code of conduct concerning advertising and promotion of medicines by marketing

authorization holders that applies to both domestic and multinational

manufacturers. The Pharmakodex is a voluntary national code from the

pharmaceutical industry and not a federal code. Adherence is voluntary, but the

code contains a formal process for complaints and sanctions. A list of the

complaints and sanctions for the last two years is not publicly available14.

5.8 Clinical Trials

In Switzerland, legal provisions require authorization for conducting Clinical Trials

by the MRA. There are additional laws requiring the agreement by an ethics

committee or institutional review board of the Clinical Trials to be performed.

Clinical trials are also required to be entered into an

international/national/regional registry, by law14.

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Legal provisions exist for GMP compliance of investigational products. Sponsor

investigators are legally required to comply with Good Clinical Practices (GCP).

National GCP regulations are published by the Government. Legal provisions

permit the inspection of facilities where clinical trials are performed.

5.9 Controlled Medicines

Switzerland is a signatory to a number of international conventions, detailed in

Table 10.

Table 10: International Conventions to which Switzerland is a signatory14

Convention Signatory

Single Convention on Narcotic Drugs, 1961 Yes

1972 Protocol amending the Single Convention on Narcotic Drugs, 1961

Yes

Convention on Psychotropic Substances 1971 Yes

United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988

Yes

Laws exist for the control of narcotic and psychotropic substances, and

precursors. The annual consumption of Morphine is 35.74 mg/capita15.

Figures regarding the annual consumption of certain controlled substances in the

country are outlined in Table 10S below.

Table 10S: Annual consumption of selected controlled substances in

Switzerland16

Controlled substance Annual consumption

(mg/capita)

Morphine 35.740220

Fentanyl 1.67

Pethidine 22.523273

Oxycodone 10.831985

Hydrocodone 0.38

Phenobarbital --

Methadone 44.057950

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5.10 Pharmacovigilance

In Switzerland, there are legal provisions in the Medicines Act that provide for

pharmacovigilance activities as part of the MRA mandate. Legal provisions also

exist requiring the Marketing Authorization holder to continuously monitor the

safety of their products and report to the MRA. Laws regarding the monitoring of

Adverse Drug Reactions (ADR) exist in Switzerland14.

A national pharmacovigilance centre is part of the MRA in Switzerland.

The pharmacovigilance centre has 9 full-time staff members. And the centre has

published an analysis report in the previous two years (Swissmedic) and it

regularly publishes an ADR bulletin. An official standardized form for reporting

ADRs is established in Switzerland. Information pertaining to ADRs is stored in a

national ADR database. The ADR database currently comprises 45,500 ADR

reports, of which 10,350 have been submitted in the past 2 years. These reports

are also sent to the WHO collaborating centre in Uppsala7. In the past 2 years

10,350 ADR reports from the database have been forwarded to the WHO

collaborating centre. Swissmedic has access to all reports available in the WHO

database.

There is not a national ADR or pharmacovigilence advisory committee. The

technical assistance or causality assessment, risk assessment, risk management,

case investigation and, where necessary, crisis management including crisis

communication is in Switzerland in the responsibility of Swissmedic. A clear

communication strategy for routine communication and crises communication

exists.

A number of steps are being considered in order to enhance the

Pharmcacovigilance system, including activities between Swissmedic and the

UMC to enhance the PV system by the introduction of an electronic submission

capability for ADRs for companies as well as primary reporters.

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Section 6 - Medicines Financing

In this section, information is provided on the medicines financing mechanism in

Switzerland, including the medicines coverage through public and private health

insurance, use of user charges for medicines, and the existence of public

programmes providing free medicines. Policies and regulations affecting the

pricing and availability of medicines (e.g. price control and taxes) are also

discussed.

6.1 Medicines Coverage and Exemptions

In Switzerland, concessions are made for certain groups to receive medicines

free of charge (see Table 11). Furthermore, the public health system or social

health insurance schemes provides medicines free of charge for particular

conditions (see Table 12).

Table 11: Population groups provided with medicines free of charge7

Patient group Covered

Patients who cannot afford them Yes

Children under 5 Yesvi

Pregnant women Yes

Elderly persons No

In Switzerland, patients who cannot afford medications can be supported by the

social assistance offices. There is no special category of people free from the co-

payment of medical care, including drugs, with the exception of pregnant women

for regular follow-up pregnancy-related care. Refer to Article 103 of the ordinance

on sickness insurance KVV available under

http://www.admin.ch/ch/d/sr/c832_102.html. There is a general 10% co-payment,

up to a maximum of 700 CHF/year for adults and 350 CHF annually for children.

vi *There is no franchise for children between 0 and 18 years of age. However, there is a co-payment of

10% also for children, even if its maximum has been set at a lower level than that for adults: 350 francs

instead of 700 francs as for adults (see quotation of article 103 of the ordinance of sickness insurance KVV)

21

There is a franchise amount below which medical care are not reimbursed, which

can vary according to the premium per month the patient selects

Table 12: Medications provided publicly, at no cost7

Conditions Covered

All diseases in the EML No

Any non-communicable diseases No

Malaria No

Tuberculosis No

Sexually transmitted diseases No

HIV/AIDS No

Expanded Program on Immunization (EPI) vaccines for children Yes

Other – HPV vaccination is free of charge, all other vaccines are included in the reimbursement list

Yes

A public health service, public health insurance, social insurance or other

sickness fund provides at least partial medicines coverage. It provides coverage

for medicines that are on the Essential Medicines List (EML) for inpatients and

outpatients. The EML, however, is not relevant in Switzerland; the list of

reimbursed pharmaceutical specialties is relevant and offers coverage for all the

conditions mentioned and additional diseases including almost all diseases and

for orphan drugs. All residents in Switzerland are compelled to have sickness

insurance, and there are many insurance companies and rather than a single

national insurance. However, tariffs and drug prices in the basic insurance

system are regulated.

Private health insurance schemes provide medicines coverage7. They are not

required to provide at least partial coverage for medicines that are on the EML.

6.2 Patients Fees and Copayments

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Co-payments or fee requirements for consultations are levied at the point of

delivery. Furthermore, there are copayments or fee requirements imposed for

medicines. Revenue from fees or from the sale of medicines is not used to pay

the salaries or supplement the income of public health personnel in the same

facility. The co-payment is set at 10% of the costs including drugs, up to 700

CHF per year9.

6.3 Pricing Regulation for the Private Sector

The true private sector of additional (not basic) insurance is not regulated - there

is free pricing and also free insurance.

Previously mentioned pricing rules apply, therefore only affect the reimbursement

of presentations, including drugs by the basis insurance schemes offered by

private insurers, under the supervision of the Federal Office of Public Health and

are regulated by law and ordinances.

The following paragraphs apply to the basic insurance system which, although

covered in part by private insurance companies, is regulated by law and

ordinances

Drug pricing of the basic insurance for all residents in Switzerland is negotiated

between providers (e.g., pharmaceutical companies) and the Federal Office of

Public Health, with the assistance of the Federal Medicines Commission, which

includes representation from stakeholders including physicians, pharmacists,

insurers and industry.

The speciality list (list of pharmaceutical specialities) with the ex-factory prices

and public prices (including distribution margins) to be reimbursed by the basic

insurance schemes is available at :

http://www.bag.admin.ch/themen/krankenversicherung/00263/00264/00265/index

.html?lang=fr

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The distribution margin is also regulated for the drugs listed on this specialty list,

and set at the level of the ordinance KLV Article 35a. This distribution margin is

to be shared between wholesalers and pharmacists, who can negotiate

individually how the margin is distributed.

The government runs an active national medicines price monitoring system for

retail prices. Regulations exist mandating that retail medicine price information

should be publicly accessible9. There is a positive list for pharmaceutical

specialties with external and public prices, the later of which includes distribution

margin and VAT of 2.5% for medicines.

6.4 Price Components and Affordability

A survey on medicine price components has been conducted in Switzerland in

the last 5 years. The median cumulative percentage mark-up between the

Manufacturer Selling Price (MSP)/Cost Insurance and Freight (CIF) price and

final medicine price for a basket of key medicines was 27% in the public sector7.

Table 12S1: Additional pricing and mark-up and fee information

Percent (%)

Median manufacturer selling price (CIF) as percent of final medicine price for a basket of key medicines (%)

66.4%

Median wholesaler selling price as percent of final medicine price for a basket of key medicines (%)

71.4%

Median pharmacist mark-up or dispensing fee as percent of retail price for a basket of key medicines (%)

8.9%

6.5 Duties and Taxes on Pharmaceuticals (Market)

Switzerland does not impose duties on imported active pharmaceutical

ingredients (APIs) or on imported finished products. Value-added tax or other

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taxes are imposed on finished pharmaceutical products, however the VAT is

lower for pharmaceuticals than other goods.

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Section 7 - Pharmaceutical procurement and distribution in the

public sector

This section provides a short overview on the procurement and distribution of

pharmaceuticals in the public sector of Switzerland.

7.1 Public Sector Distribution

There is no public sector distribution system in Switzerland.

7.2 Private Sector Distribution

Legal provisions exist for licensing wholesalers and distributors in the private

sector. There are national guidelines on Good Distribution Practices (GDP). A list

of GDP certified wholesalers and distributors exists in the private sector7.

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Section 8 - Selection and rational use of medicines

This section outlines the structures and policies governing the selection of

essential medicines and promotion of rational drug in Switzerland.

8.1 National Structures

A National Essential Medicines List (EML) does not exist. National Standard

Treatment Guidelines (STGs) for the most common illnesses are not produced or

endorsed by the MoH in Switzerland.

There is not a public or independently funded national medicines information

centre providing information on medicines to prescribers, dispensers and

consumers9. A survey on rational use of medicines has been conducted in the

previous two years7. There is not a national programme or committee, involving

government, civil society, and professional bodies, to monitor and promote

rational use of medicines.

A written National Strategy for containing antimicrobial resistance exists, and was

last updated in year7.

As noted previously, there is no EML in Switzerland. Rather, there is a much

larger list of more than 2,500 reimbursed medications which are therefore

available for all residents in Switzerland.

(http://www.bag.admin.ch/themen/krankenversicherung/00263/00264/00265/inde

x.html?lang=fr)

8.2 Prescribing

Legal provisions exist to govern the licensing and prescribing practices of

prescribers9. Prescribers in the private sector dispense medicines7. Legal

provisions restricting or limiting dispensing by prescribers exist in some Swiss

cantons, but in others, the physicians are allowed to sell drugs in their offices

which are privately owned.

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There are not regulations requiring hospitals to organize/develop Drug and

Therapeutics Committees (DTCs)7.

The training curriculum for doctors and nurses is made up of a number of core

components detailed in Table 13.

Table 13: Core aspects of the medical training curriculum7

Curriculum Covered

The concept of EML --

Use of STGS --

Pharmacovigilance Yes

Problem based pharmacotherapy Yes

Mandatory continuing education that includes pharmaceutical issues is required

for physicians.

Prescribing by INN name is not obligatory in the either the private or public

sector7.

8.3 Dispensing

Legal provisions in Switzerland exist to govern dispensing practices of

pharmaceutical personnel7. The basic pharmacist training curriculum includes a

spectrum of components as outlined in Table 14.

Table 14: Core aspects of the pharmacist training curriculum

Curriculum Covered

The concept of EML Yes

Use of STGS Yes

Drug information Yes

Clinical pharmacology Yes

Medicines supply management Yes

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Substitution of generic equivalents at the point of dispensing is allowed in both

private and public sector facilities7. Neither antibiotics nor injectable medicines

are sold over-the-counter without a prescription.

29

List of key reference documents:

1 World Health Organization (WHO) (2010), “World Health Statistics 2010”, WHO Press, Geneva.

Available online: http://www.who.int/whosis/whostat/2010/en/index.html.

2 World Health Organization (WHO) (2009), “World Health Statistics 2009”, WHO Press, Geneva.

Available online: http://www.who.int/whosis/whostat/2009/en/index.html.

3 International Monetary Fund (IMF) (2009) World Economic Outlook Database, Available online:

http://www.imf.org/external/pubs/ft/weo/2011/01/weodata/index.aspx

4 World Development Indicators, The World Bank. April 2009. Available online:

http://data.worldbank.org/data-catalog/world-development-indicators

5 National Health Accounts 2007, available online: http://www.who.int/nha/country/che/en/

6 Calculated based on data provided in World Health Organization (WHO) (2010), “World Health

Statistics 2010”, WHO Press, Geneva. Available online:

http://www.who.int/whosis/whostat/2010/en/index.html; and National Health Accounts 2007,

available online: http://www.who.int/nha/country/che/en/ 7 Ministry of Health, Switzerland (2011)

http://www.bag.admin.ch/themen/krankenversicherung/index.html?lang=en

http://www.bag.admin.ch/themen/krankenversicherung/index.html?lang=fr

8 Switzerland Federal Statistical Office (2009), Available online:

http://www.bfs.admin.ch/bfs/portal/en/index.html

9 World Health Organization (WHO) (2009), "Country pharmaceutical situations, fact book on

WHO Level 1 indicators 2007", WHO Press, Geneva. Available online:

http://apps.who.int/medicinedocs/documents/s16874e/s16874e.pdf

10 World Trade Organization (1995), Member list available online:

http://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm

11 Swiss Federal Institut of Intellectual Property. Available online: https://www.ige.ch/en/legal-

info/organizations/wtotrips.html

12 Swissmedic, (2011) Law on Therapeutic Products. Available online:

http://www.swissmedic.ch/rechtstexte/00201/00203/index.html?lang=en

13 Swissmedic - Swiss Agency for Therapeutic Products. Available online:

http://www.swissmedic.ch/

14 International Narcotics Control Board, 2010. Available online:

http://www.incb.org/incb/en/annual-report-2010.html

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15

International Narcotics Control Board, 2010. Available online:

http://www.incb.org/incb/en/annual-report-2010.html