Annual Report - Asociace inovativního farmaceutického průmyslu

Annual Report
Association of Innovative Pharmaceutical Industry
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A Word of Introduction
The second half of the 20th century brought
over a billion Czech crowns are invested in their
a major shift in the prevention and treatment
research and development every year.
of numerous serious diseases, which had
before been considered incurable. Innovative
medications
gave
hundreds
of
thousands
of patients a chance to get well, to see their
health condition improve, and to enjoy a better
quality of life.
However, there are still many diseases, such as
cancer, HIV/AIDS or some rare diseases and
diseases that contemporary medicine does not
know how to cure successfully. Therefore, the
innovative pharmaceutical industry relentlessly
works to develop new and more effective active
substances. Just in the Czech Republic alone,
PharmDr. Monika Horníková
AIFP President
GlaxoSmithKline
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Table of
Contents
Nevertheless, with new discoveries we also face
new obstacles and challenges. The financial
crisis has particularly impacted on the costs
of developing new pharmaceuticals, and we see
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A Word of Introduction
Table of Contents
Association Profile
Member Companies
Organization Structure
Working Groups
Contact and Identification Details
Balance Sheet
Auditor’s Statement
Major Projects
a rising share of generic drugs or counterfeit
drugs in the global markets.
In order to overcome these and other obstacles,
we need to continue to believe in the research
potential, promote transparent cooperation
between
the
manufacturers
of
innovative
medicines and the expert public, and ensure
that patients can get prompt access to modern
pharmaceuticals.
Mgr. Jakub Dvořáček
AIFP Executive Director
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Association Profile
Member Companies
In 2012, the Association of Innovative Pharmaceutical Industry (AIFP) associated 30 companies in the
Czech Republic that can develop and launch new, more effective, and safer medications.
Core Values
Trust
Benefits for
Patients
Innovation
Ethical Conduct
Strategic Pillars
The Association’s activities are based on three pillars. The first one is the Availability of Innovative
Medicines. The AIFP in particular promotes the fair and timely assessing of the benefits of innovative
pharmaceuticals and improving their availability to patients. In doing so, the association actively
communicates with professional organizations and their representatives as well as with representatives
of public administration authorities, patient organizations, and other stakeholders.
The second pillar is Ethics and Transparency. The Association’s and its members’ activities need
to adhere to the Code of Ethics. This document defines binding internal rules of self-regulation,
which are in most cases stricter and more specific than the existing Czech legislation. The AIFP also
promotes a wider application of these principles also to non-member pharmaceutical companies,
improvements in the standards of cooperation with the expert medical public, and better observance
of general principles in the Czech pharmaceutical market as well as in the healthcare sector.
The third pillar is Benefits for Society. By this we do not mean benefits for patients only, for whom
new medicines are often the only chance of improvement of their health condition. This pillar also
includes increasing the society’s awareness and knowledge of medicine in respect of pharmaceutical
development and clinical trials conducted. Last but not least, there are benefits for the Czech
economy as well. New medicines can namely shorten the duration of hospitalization, reduce the
number of required interventions, and make it possible for patients to return to normal life earlier. We
believe that the results of our research and development, i.e., innovative drugs, can bring significant
cost reductions in the social and pension system, thus improving our country’s competitiveness.
International Cooperation
The AIFP is a member of the European Federation of Pharmaceutical Industries and Associations
(EFPIA) and intensely cooperates with the International Federation of Pharmaceutical Industries and
Associations (IFPMA) and Pharmaceutical Research and Manufacturers of America (PhRMA).
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GlaxoSmithKline
Monika Horníková
GlaxoSmithKline
1st Vice-President
Organization Structure
General Meeting
Board
Executive Team
President
Monika Horníková
GlaxoSmithKline
Executive Director
Jakub Dvořáček
Audit Committee
Ethics Committee
Chairman
Jean-Phillipe Duc
Amgen
Chairman
Patrik Kastner
Baker & McKenzie
Petr Janíček
Lundbeck
Pavel Kovář
Pfizer
Marco Pierini
Pfizer
Martin Pospíšil
Lundbeck
1st Vice-President
Secretary General
Aneta Dostálová
Fraser Hall
Novartis
Office Manager
Zuzana M. Dizaai
1st Vice-President
Michaela Hrdličková
Biogen Idec
Project Management:
Lenka Poleková
Celgene
Project Manager R&D
Kateřina Mrkvičková
Eva Koňáková
Merck
Project Manager
Patient Organization
Academy
Michal Bernard
Václava Zimová
Actelion
(till 31 August 2012)
2ⁿd Vice-President
Michaela Poleková
Celgene
Member
Ivo Žídek
Sanofi
Martin Cikhart
Janssen-Cilag
Member
Beata Hauser
Ipsen
Daniel Bělík
Amgen
Member
Daniela White
Novo Nordisk
Antonio Payano
Bayer
Karel Rychna
Novo Nordisk
Member
(from 13 September 2012)
Jean-Phillipe Duc
Amgen
Václav Špičák
Allergologist and Clinical
Immunologist
Baker & McKenzie
Patrik Kastner
Baker
& McKenzie
Pavel Kovář
(till 31 August 2012)
Pfizer
1st Vice-President
Pavel Kovář
Fraser
Hall
(till 31 August 2012)
Pfizer Pospíšil
Novartis
Martin
Fraser Hall
Lundbeck
Novartis
Martin Pospíšil
1st
Vice-President
Lundbeck
Michaela Hrdličková
Lenka
Poleková
1st
Vice-President
Biogen
Idec supreme steering body
ProjectofManagement:
Celgene five times
The
the Association is the General Meeting, which convenes
Michaela Hrdličková
Lenka Poleková
a year.
representatives
of all member companies.
Biogen
Idec It is attended byProject
Management:
Celgene
2ⁿd Vice-President
Manager R&D
Eva Koňáková
Michaela Poleková
Kateřina Mrkvičková
Merck
2ⁿd Vice-President
Managerbody.
R&D The Board meets twice a month and
Eva decides
Koňákováon all
Celgene
The Board represents Project
our executive
Michaela Poleková
KateřinaManager
Mrkvičková
Merck
Project
of the Association’s matters
unless the Articles of the AIFP stipulate that particular Václava
mattersZimová
are to be
Celgene
Member
Patient Organization
Actelion
Project
Manager
Václava
Ivo Žídek
decided by the GeneralAcademy
Meeting.
The Association is represented toward third parties
by itsZimová
Executive
Member
PatientBernard
Organization
ActelionCikhart
Sanofi
Michal
Martin
Director.
Ivo Žídek
Academy
Janssen-Cilag
Sanofi
Michal Bernard
Martin Cikhart
Member
The financial performance of the AIFP is supervised by the Audit Committee, which Daniel
is an independent
Janssen-Cilag
Beata Hauser
Bělík
Member
Ipsen
Amgen
body whose 3 members are always elected for a term of two financial years. The last elections took
Beata Hauser
Daniel Bělík
Ipsen place in February 2012.
Amgen
Member
Antonio Payano
Daniela White
Bayer
Member
Antonio Payano
Novo
Nordisk
The Ethics Committee sees to it that the AIFP’s Code of Ethics is observed, checks randomly
selected
Daniela White
BayerRychna
Karel
non-intervention studies conducted by the member companies, deals with complaints
and,
if a breach
Novo Nordisk
Member
Novo
Nordisk
(from 13 September 2012)
Karel Rychna
occurs, it is authorized to impose a penalty on the company in question. The Ethics Committee is an
Member
Jean-Phillipe
Duc
Novo Nordisk
Václav
Špičák
(from
13
September 2012)
Amgen
independent
multi-disciplinary body consisting of 11 members, two of which are external
members.
Allergologist
and Clinical
Jean-Phillipe Duc
Václav Špičák
Immunologist
2012.
AmgenThe members are always elected for two years. The last elections took place in February
Allergologist and Clinical
Immunologist
Jakub
Dvořáček
Secretary
General
Aneta Dostálová
Secretary General
Aneta Dostálová
Office
Manager
Zuzana M. Dizaai
Office Manager
Zuzana M. Dizaai
Amgen
Jean-Phillipe Duc
Amgen
Petr Janíček
Lundbeck
Petr Janíček
Lundbeck
Marco
Pierini
Pfizer
Marco Pierini
Pfizer
The high quality and specialized content of the materials currently prepared by the AIFP for both the
lay and the expert public is the fruit of our Working groups, formed by volunteers from our member
companies. Expert discussion Platforms are a source of themes and ideas, as well as a place for
sharing experience.
Availability of
Innovativeof
Availability
Medicines
Innovative
Medicines
Governmental
Affairs
Working Group
Governmental Affairs
Health Economy Working
Working Group
Group
Health Economy Working
Medical Working Group
Group
- Registration
-Medical
ClinicalWorking
Trial
Group
- Pharmacovigilance
Registration
- Medical
Clinical Trial
- Pharmacovigilance
- Medical
Working Groups in 2012
Working Groups in 2012
Ethics and
Transparency
Ethics and
Transparency
Transparency & Compliance
Working Group
Transparency & Compliance
Working Group
Benefits for
Societyfor
Benefits
Society
Value of Innovation
Working Group
- Orphan
Drugs
Value
of Innovation
- Vaccines
Working
Group
- Orphan Drugs
- Vaccines
Platforms in 2012
Platforms in 2012
Working Groups in 2012
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Availability of
Innovative
Medicines
Governmental Affairs
Ethics and
Transparency
Transparency & Compliance
Benefits for
Society
Value of Innovation
Public Relations
Platform
Public
Relations
Platform
Human Resources
Platform
Human
Resources
Platform
Chief Financial
Officers
Platform
Chief Financial
Officers Platform
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Working Groups
Governmental Affairs Working Group
In 2012, this Working group was led by Lenka Poleková.
The Governmental Affairs Working Group primarily dealt with the
pricing and reimbursement regulation of pharmaceuticals. In 2012,
they particularly focused on issues pertaining to the methodology
of collecting data on treatments with highly innovative medicines
(HIM), commitments for the purpose of determining temporary
HIM reimbursements, criteria for determining permanent HIM
reimbursements, and the lack of action on the part of the State Institute
for Drug Control in a proceeding on prices and reimbursements.
The group continued to prepare the AIFP’s position document
on the maximum prices of pharmaceuticals, and cooperated on preparing position documents
on orphan drugs and on health technology assessment (HTA). Last but not least, the group dealt
with a draft amendment of the statutory definition of HIM and with system changes in the pricing
Health Economy Working Group
In the first half of 2012, this Working group was led by Fraser Hall,
and in the second half of the year the group met together with the
Governmental Affairs Working Group led by Lenka Poleková.
In 2012, the Health Economy Working Group participated in preparing
the AIFP’s position document on health technology assessment (HTA)
in relation to its impacts on the innovative pharmaceutical industry,
and also monitored the process of HTA methodology preparation at
the Ministry of Healthcare.
The group had the following members in 2012: Alena Blechová,
Jan Branda, Tomáš Březina, Lenka Bulejová, Magdalena Cook, Jan Doležel, Filip Dostál, Hana Foitová,
Zbyněk Gregor, Petr Hájek, Michaela Hrdličková, Pavel Karásek, Aleš Kmínek, Zdeněk Kučera, Jiří
Lamka, Zdenka Ledvinková, Pavlína Pavlíková, Lucie Pomajslová, David Skalický, Robert Sýkora, Šárka
Veselá, Ivo Žídek, and Jana Žížalová.
Value of Innovation Working Group
and reimbursement regulation of pharmaceuticals.
Every two months the group met for an internal “working breakfast”, where they discussed topical
issues with key stakeholders.
In 2012 the group had the following members: Alena Blechová, Tomáš Březina, Magdalena Cook,
Filip Dostál, Luboš Dvořák, Hana Foitová, Zbyněk Gregor, Jiří Hladík, Monika Horníková, Michaela
Hrdličková, Lenka Kaška, Aleš Kmínek, Jolana Kubátová, Zdeněk Kučera, Petr Likavec, Simona
Masílková, Filip Mavrov, Pavol Mazan, Pavlína Pavlíková, Kateřina Pechová, Lucie Pomajslová, Martin
Pour, Jan Příborský, David Skalický, Robert Sýkora, Jana Šimonová, Šárka Veselá, Eva Veverková,
Magdalena Vyhnánková, and Jana Žížalová.
In 2012, this Working group was led by Michaela Hrdličková.
The Working group’s main activities included supporting and
promoting current trends in innovative research and its benefits for
Czech patients. At its regular sessions, the Working group worked
to implement projects, prepare the AIFP’s position documents, and
to organize press conferences.
In 2012, the group organized five press conferences: on the occasion
of the World Rare Disease Day, on the topic of the chronic patient,
and on clinical trials. Another two meetings with journalists were
dedicated to the project of the “Patient Organization Academy”
(see below) and the “Industry Meets Academia” R&D conference (see below).
The group had the following members in 2012: Lenka Kaška, Eva Koňáková, Radek Korbel, Jana
Mádlová, Filip Mavrov, Martin Pospíšil, Eva Vaverková, and Magdalena Vyhnánková.
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Orphan Drugs Subgroup
In November 2012, the group met in a wider plenum that included representatives of all AIFP member
companies, where new developments in the legislation and the AIFP’s activities were presented.
The Orphan Drugs Subgroup met twice in 2012 on an ad-hoc basis to prepare the AIFP’s position
document on orphan drugs, on which it cooperated with the Governmental Affairs Working Group.
The group had the following members in 2012: Michaela Hrdličková, Radek Korbel, Jana Mádlová,
In 2012, the group had the following members: Petr Abrman, Michaela Cibulová, Jana Doksanská,
Hana Horáková, Pavel Kovář, Luboš Melichar, Zuzana Rothová, Karel Tichý, and Vlasta Trojanová.
and Lenka Poleková.
Transparency & Compliance Working Group
Vaccination subgroup
In 2012, the Vaccination Subgroup was led by Monika Horníková.
In 2012, this group was led by Beata Hauser.
The subgroup dealt with vaccination issues in the Czech Republic
The Working group in particular prepared projects and documents
and worked on a uniform communication strategy.
pertaining to the AIFP Code of Ethics and the promotion
of a transparent environment in the Czech healthcare sector. The
The group had the following members in 2012: Lumír Bobek,
activities were communicated and/or implemented in cooperation
Romana Hengalová, Igor Kohl, Tomáš Kvasnička, Pavol Mazan, Radka
with key stakeholders, such as the Czech Medical Association of Jan
Šíchová, and Karel Torner.
Evangelista Purkyně (ČLS JEP), Transparency International, etc.
The first project in which the Working group was involved was
the Disclaimer – a joint statement by the AIFP and ČLS JEP, which
regulates and makes significantly more transparent the cooperation
between the pharmaceutical industry and experts or authors of articles in specialized magazines and
Medical Working Group
journals. The actual project implementation is scheduled for 2013.
During the year the group prepared documents and other materials to comment on the amended
acts on pharmaceuticals and on advertising regulation. In connection with both amendments, the
In 2012, this Working group was led by Daniela White.
AIFP became a partner of the autumn expert conference organized by Mladá fronta under the title
“Does new legislation help the Czech healthcare sector?”, which focused on the key changes and
The Working group met in 2012 in particular to discuss the draft
amendment to the Pharmaceuticals Act, which has impacted on
the registration of medicinal products and pharmacovigilance.
They also cooperated in presenting and implementing an EFPIA
project, which follows up on the EU Anti-Counterfeiting Directive
their potential impacts on the healthcare sector.
Last but not least, the group prepared educational lectures for professional associations and students
of medical and pharmaceutical faculties, and they continuously managed a unique database of the
AIFP’s congresses (see below).
and aims at preventing the entry of falsified medicines in the official
The group had the following members in 2012: Veronika Bártová, Milada Brabcová, Patrik Kastner,
supply chain in the Czech Republic. The Medical Working Group
Pavel Kovář, Jan Ledecký, Tereza Ošancová, Martin Pospíšil, and Silvia Přitasilová.
actively communicated the outcomes of an Ernst & Young study
that monitored the benefits of clinical trials for the Czech Republic.
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Contact and Identification Details
Auditor’s Statement
For the stockholders of the company /general meeting/
Asociace inovativního farmaceutického průmyslu Praha
Association of Innovative Pharmaceutical Industry
IBC Building
Tel.: +420 224 832 551
Pobřežní 3
Fax: +420 224 832 554
186 000 Prague 8
www.aifp.cz
Established:
24 November 1993
Legal form:
A special-interest association of legal entities
Registration No.:
70970173
VAT ID:
CZ70970173
Registered with the City Hall of the Capital City of Prague,
Trade Licensing and Civil Law Department, under No. 99/98.
We have audited the accompanying financial statements of the company AIFP , IBC Pobřežní 3 , Prague 8, IČ 70970173,
which comprise the balance sheet as of 31 December 2012, and the income statement for the year then ended 31.12.2012, and
a summary of significant accounting policies and other explanatory notes. Information about company AIFP is presented in
Note 1 to these financial statements.
Statutory Body’s Responsibility for the Financial Statements
The statutory body of company AIFP Prague is responsible for the preparation of financial statements that give a true and fair
view in accordance with Czech accounting regulations and for such internal control as statutory body determines is necessary
to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.
Auditor’s Responsibility
Our responsibility is to express an opinion on these financial statements based on our audit. We conducted our audit in accordance
with the Act on Auditors and International Standards on Auditing and the related application guidelines issued by the Chamber
of Auditors of the Czech Republic. Those laws and regulations require that we comply with ethical requirements and plan and
perform the audit to obtain reasonable assurance whether the financial statements are free from material misstatement.
An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements.
The procedures selected depend on the auditor’s judgment, including the assessment of the risks of material misstatement of the
financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control
relevant to the entity’s preparation of the financial statements that give a true and fair view in order to design audit procedures
that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entity’s
internal control. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness
of accounting estimates made by management, as well as evaluating the overall presentation of the financial statements.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.
Balance Sheet
The Association generated a loss of CZK 1,653,075.74 in the year 2012. This loss will be covered from
the retained earnings of previous years. A decision on how the loss is to be covered is going to be
made at the Association’s General Meeting.
This Annual Report includes:
• • Financial Statements, which consist of the account inventory as of 31 December 2012,
Balance Sheet, Profit and Loss Statement, and Annex to the Financial Statements for 2012.
Auditor’s Statement on the Financial Statements.
Opinion
In our opinion, the financial statements give a true and fair view of the financial position of company AIFP Prague as
of 31 December 2012, and of its financial performance for the year then ended 31.12.2012 in accordance with Czech
accounting regulations.
We have audited the annual report of company AIFP Prague for consistency with the financial statements for the year ended 31
December 2012 which are included in this Annual Report . The correctness of the annual report is the responsibility of company
AIFP’s statutory body. Our responsibility is to express an opinion on the consistency of the annual report and the financial
statements based on our audit.
We conducted our audit in accordance with International Standards on Auditing and the related application guidelines issued by
the Chamber of Auditors of the Czech Republic. Those standards require that the auditor plan and perform the audit to obtain
reasonable assurance about whether the information included in the annual report describing matters that are also presented in
the financial statements is, in all material respects, consistent with the relevant financial statements. We believe that our audit
provides a reasonable basis for our opinion.
In our opinion, the information included in the annual report of Company AIFP for the year ended 31 December 2012
is consistent, in all material respects, with the financial statements referred to above.
Prague 22.4.2013
AUDIT IB, s.r.o.
Com. No. 146
Janovského 12
Praha 7
Ivana Podhráská
Com. No. 564
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Major Projects
In 2012, the Association carried out various activities for members of the expert public, representatives
of public administration authorities, research centres, journalists, AIFP member companies, and other
stakeholders. Below is a list of major projects, grouped by the strategic pillars described above.
Ethics and Transparency
Educational Lectures
In 2012, a follow-up was made of popular educational presentations for the expert public and
students of medical and pharmaceutical faculties, this time dedicated to the ethics in the doctor–
pharmaceutical corporation relationship. The lectures were held by the Chairman of the AIFP Ethics
Committee and/or AIFP Executive Director. In total, 9 presentations were held all over the Czech
Republic in 2012.
Database of Congresses
The Association regularly updated its own, publicly accessible database of congresses that were
attended by experts sponsored by the AIFP member companies. For more information including an
overview of the congresses held in 2012, please visit www.lekarskekongresy.cz.
Industry Meets Academia; source: Senate Office Archives
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Availability of Innovative Medicines
“Industry Meets Academia” Conference
On 27 November 2012, a conference was organized at the Senate of the Czech Parliament under
the title “Industry Meets Academia”. The objective was to promote cooperation of academic research
centres, small and medium-sized enterprises, and pharmaceutical corporations in the research and
development of innovative drugs. The conference was attended by a hundred participants from the
Czech Republic and abroad.
The conference was accompanied by a press conference with the title “Where is the biological
development in the Czech Republic headed?”, which introduced the present journalists to the latest
developments in biotechnology and its use, benefits for patients, and current research projects.
Clinical Trial Analysis
In 2012, Ernst & Young analyzed the benefits for the Czech Republic of clinical trials conducted by the
member companies. The results were presented to media representatives during a press conference
with the title “Clinical Trial Benefits for the Czech Republic”, held on 17 October 2012. The analysis
became one of the key documents mapping the significance of clinical trials for the Czech expert
public, patients, and centres for biomedical research in the Czech Republic.
Coding and Serialization Seminar
The Association also organized a seminar for its member companies and members of the expert
public, dedicated to the transposition of the EU Anti-Counterfeiting Directive in the Czech legislation
and the related prevention of entry of falsified drugs in the Czech market. The seminar was held
on 15 March 2012 and was attended by experts from abroad as well.
Patient Organization Academy
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Benefits for Society
Informal Meetings on World Rare Diseases Day
On 21 February 2012, an informal meeting took place with journalists on World Rare Disease Day.
The purpose of the meeting was to make the journalists familiar with the topic of rare diseases
and the problems they pose, with the 2010-2020 National Strategy for Rare Diseases, and the
related European recommendations. The discussion also touched on treatment issues and current
therapeutic options.
Patient Organization Academy
This Academy has been established in cooperation with the Pharmaceutical Research and
Manufacturers of America (PhRMA) foundation and the Czech Coalition for Health association. The
purpose was to promote independence, a professional approach and permanent development
of patient associations. As part of the Academy, the Association organized interactive, educational
seminars and workshops complemented with practical exercises led by experienced lecturers. Patient
organizations could participate in the seminars free of charge. The costs of operating the Academy,
which average at around CZK 60,000 per person, were fully covered by the AIFP. The project also
includes an informative website that maps the available financial calls appropriate for patient
organizations in the Czech Republic and the EU. Patient organizations also used the opportunity to
consult specialists in project management and non-profit organization management.
A total of 8 presentations were held in 2012, which were attended by 41 patient organizations. The
project is going to continue in 2013.
For more information on the project, please refer to www.pacientskaakademie.cz.
“Chronic Patient” Press Conference
On 13 November 2012, a press conference was held under the title “Chronic Patient”. The purpose
was to present to the media representatives the issues, financial and social aspects connected with
providing care to chronic patients, and the impact on their families and the government.
Patient Organization Academy
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Association of Innovative Pharmaceutical Industry
www.aifp.cz
IBC, Pobřežní 3, Prague 8, Post Code 186 00
Tel.:+420 224 832 551, Fax: +420 224 832 554