Statement of the Slovak Association of Research-Based Pharmaceutical Companies (SAFS)
Regarding Visits of Medical Representatives from 6/12/2011
SAFS members will fully respect the new Act No. 362/2011 Coll. on Drugs and Medical Aids and on amendments to certain acts and that in the provision, which amended the Act on Advertising No. 147/2001 Coll. and on change and amendment of some acts and that §8 paragraph 6 “on the ban of practice of visiting persons authorized to prescribe drugs with the aim to promote drugs during their office hours“.
The Act No. 362/2011 Coll. on Drugs bans only the visits connected with drug promotion. However, all other visits connected with promotion of any other products or services are still allowed. SAFS called the attention of the lawmakers during the entire legislative process to the fact that such regulation may cause many suspicions and misunderstandings.
Our opinion has been repeatedly published in the media as well:
Press release 4/5/2011
SAFS: We are in favour of clear rules
The Health Care sector has recently prepared and publically presented several legislative intentions: in September 2010 and in February 2011 two different proposals of amendement to Act No. 577/2004 Corpus Juris on the Scope of Health Care and in March 2011 a completely new wording of the Drug Act. These two acts are the key acts equally for patients and doctors, and also for pharmaceutical industry and other involved participants.
SAFS considers alarming the fact that new legislation in the health care sector is prepared lately without dialogue and communication with external environment, which we consider to be the basic condition not only of transparency, but also democracy in general. It is desirable for Act amendments in the health care sector to be prepared with quality and to bring order and legal security into the system for all participating parties.
Read more in PDF
Press release 30/3/2011
Is Decision Making in Drug Policy INDEPENDENT?
The pharmaceutical industry associated in SAFS has been trying to be a constructive partner to the Ministry of Health of SR regardless its political orientation, because we believe we share the common goal – rid the patient of suffering caused by illnesses. Transparency, predictability and independence of processes regulating the drug policy is very important for producers, distributors and pharmacists as well. It helps effective spending of state means, health system as such and last but not least the patients. Some measures, which form a part of the proposed amendment to Act on the Scope of Health Care, will cause the decision making about public resources in the amount of approximately EUR 1.5 billion (SKK 45 million) annually to become non-transparent and secret.
Read more in PDF
• SAFS Statement on transparency of payments to health-care professionals.
SAFS member companies agreed on March 2011 General Assembly following common statement on transparency of payments and sponsorships to healthcare professionals:
" SAFS supports proposal to disclose data on providing any kind of financial remuneration and non-financial benefits to HC providers.
All subjects including non-pharma companies should provide the data in specified format to a body assigned by the law (f.e. State Insitute for Drug Control)."
• SAFS has new members
Since 1 April 2010 SAFS has two new members – pharmaceutical companies Actelion and UCB. Their membership in the association was agreed by the Board of directors of SAFS at its meetings held on 12 and 31 March. SAFS welcomes both companies as members and looks forward to the cooperation.
More
• SCRIP, March 9, 2010
Slovak pharma multinationals' association elects new board
Slovakia’s association of research-based pharmaceutical companies (SAFS) has elected a new board. Dr Pavol Trnovec of GlaxoSmithKline, who was previously its vice-chairman, will lead SAFS as chairman. He replaces Dr Miroslav Lednar of Sanofi-Aventis, who remained on the board; he will supervise SAFS members' compliance with ethical requirements in marketing.
More
•Slovak Association of Research-Based Pharmaceutical Companies elects new Board
Slovak Association of Research-Based Pharmaceutical Companies (SAFS) elected a new Board at its recent Annual Meeting. MUDr. Pavol Trnovec of GlaxoSmithKline has become the new SAFS Board Chairman. Other Board members include Daniel Weber of Novartis also elected as the Vice-chairman, MUDr. Miroslav Lednár of sanofi-aventis, MUDr. Dana Böhmová of Eli Lilly and Klaus Mittmann of Bayer.
More
•The Slovak Spectator (Dec. 14 – 20, 2009)
Treatment policy debated
More
•The Slovak Spectator (Dec. 7 - 13, 2009)
'Patent protection plays an irreplaceable role',
says pharmaceuticals body
More
• The Slovak Spectator (Nov. 30 - Dec. 6, 2009)
Medicines policy in Slovakia
More
•The Slovak Spectator (Oct. 12 – 18, 2009)
Developing new drugs is now taking much longer
More
• SAFS: “Cooperation with Professional Medical Community within Clearly Set Rules is a Necessity”
Following a positive response to previous activities concerning the cooperation of the pharmaceutical industry and representatives of the medical profession in the field of ethics, the SAFS has decided to compile a set of information to describe mutual relations between the industry and the professional medical community under the effective laws.
More
• MEPs and industry debate shared commitment to deliver 21st Century healthcare systems in times of crisis
European policymakers and the pharmaceutical industry need to work collaboratively to ensure the current financial crisis does not stand in the way of delivering healthcare systems fit for the 21st century. Representatives of EFPIA, the voice of the research-based pharmaceutical industry in Europe, and MEPs involved in healthcare issues discussed a common agenda to shape the future of healthcare in Europe.
More
• Pharmaceutical Sector Inquiry - highlights regulatory shortcomings and need for a strong, effective patent system in Europe
Final report tones down earlier language, makes constructive policy recommendations.
More
• SAFS with Re-elected Board of Directors
Slovak Association of Research-Based Pharmaceutical Companies (SAFS) has a new Board of Directors. At its annual meeting held at the end of January, the members of the association confirmed MUDr. Miroslav Lednár and MUDr. Pavol Trnovec in the office after the end of their office terms. Ing. Štefan Mesároš, MUDr. Vladimír Pacholík and Klaus Mittmann continue as the other members of the Board of Directors.
More
• EFPIA – Myths about pharma industry (A. Higgins)
If we truly want to look after the health of European patients and enhance the competitiveness of Europe by supporting one of its most vital industry sectors, then I believe that we should stay focused on the facts rather than the myths. In this spirit, let me now address some myths and share with you the facts...
More
• EFPIA – EC Pharmaceutical Sector Inquiry
Preliminary report fails to address real issues impeding patient access to innovative medicines and the urgent need for a more efficient generic market in Europe.
More
• Pharma invests more in R&D than any other sector
The European pharmaceutical industry association EFPIA has today released the 2008 Edition of “Pharmaceutical Industry in Figures”, which shows that the pharmaceutical industry accounts for no less than 19% of global business R&D expenditure and 5.8% of EU manufactured exports. The industry employs more than 643,100 people in Europe of which 107,000 work in R&D units.
More
• Annex to the Code of Conduct valid for SAFS members only from April 17th, 2008
To the Code of Conduct of Pharmaceutical Industry in Slovakia has been from SAFS initiative processed Annex valid for SAFS members only.
The Annex came into force on April 17th, 2008.
More
• SAFS has new Board
Bratislava, 26 February 2008 - Slovak Association of Research-Based pharmaceutical Companies (Slovak abbr.: SAFS) has new Board since February 2008. Chairman of SAFS is Miroslav Lednár and vice-chairmen are Štefan Mesároš and Pavol Trnovec. Other members of SAFS Board are Vladimír Pacholík and Klaus Mittmann.
More
• Servier Slovensko as a new member of SAFS
The Slovak Association of Research Based Pharmaceutical Companies (SAFS) was joined by a new member – the company Servier Slovensko. Number of member companies of SAFS was thus extended to become twenty-two.
More
• “We’re grateful for the chance to help”
SAFS has donated its 2007 proceeds from the sale of the book A Mosaic of Slovak Medicine to the Plamienok Children's Hospice. The donation was presented by symbolic cheque in the value of 50.000 Sk to the hospice director and the book’s “godmother”, MUDr. Mária Jasenková.
More
• A Mosaic of Slovak Medicine for Ministry of Health
During Christmas period, SAFS donated gift of books to the Ministry of Health of the SR. 50 copies of the book A MOSAIC OF SLOVAK MEDICINE accepted General Director of Section of Health MUDr. Adam Hochel from Executive Director of SAFS Soňa Strachotová.
More
• Gift of Books for Foreign Affairs Ministry of the SR
In December 2007, SAFS donated 50 copies of the book A MOSAIC OF SLOVAK MEDICINE to the Foreign Affairs Ministry of the Slovak Republic. Ing. Vasiľ Grivna, ambassador and director of external affairs, accepted the gift from the PR and Communication Manager Ing. Štefánia Cicková.
More
• FAQ
After more than a yearly existence of Joint declaration between SLK (Slovak Medical Chamber), SLS (Slovak Medical Society) and SAFS there have been several questions raised on how some provisions of the declaration can be understood in practice.
That was the reason for creating a brochure of Frequently Asked Questions (FAQ). You can find the material in Slovak language here
 Don‘t miss!
A Mosaic of Slovak Medicine you can already buy via internet. All the revenues from the sale of the book will go to the Plamienok Children’s hospice. More information you can find on www.martinus.sk.
Newsletter
SAFS started to publish an email Newsletter in Slovak language with articles about the association, pharmaceutical industry and healthcare sector.
The Newsletter will be distributed every four months.
If you would like to receive the Newsletter or read previous issues (in Slovak), subscribe HERE, please.
Annex No. 3 to the Ethical Code
Annex No. 3 to the Ethical Code of pharmaceutical industry in Slovakia has been processed upon the suggestions of Ethical Committee. The Amendment comes into force on July 1st, 2007.
More
A Mosaic of Medicine introduces Slovak doctors
A SPLASH of sparkling wine sent the book A Mosaic of Slovak Medicine on its voyage into the Panta Rhei book store in Bratislava’s Polus City Centre shopping mall on April 26. SAFS together with authors of interviews (Dagmar Krištofičová and Gustav Bartovic) tried to remove the white jackets from 16 prominent personalities of Slovak medicine to uncover the person behind the profession. More
Annex No. 2 to the Ethical Code
Annex No. 2 to the Ethical Code of pharmaceutical industry in Slovakia has been approved by members of Ethical Committee at January’s assembly. The Annex comes into force on April 1st, 2007. More
Principles for partnership between the pharmaceutical industry and patient organisations
The pharmaceutical industry represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and patient organisations have important areas of common interest. As a result, many companies and industry associations have developed constructive partnerships with patient organisations. EFPIA proposed and up-dated the principles for partnership between the pharmaceutical industry and patient organisations, which were originally endorsed in 1998.
The purpose of the up-date is to further improve the transparency of such partnerships and to encourage diversification of funding sources for patient groups.
These points serve as overarching guiding principles at a European level as well as at a national level for the relationships between the pharmaceutical industry and patient groups. More
Annex to the Ethical Code
Annex No. 1 to the Ethical Code of pharmaceutical industry in Slovakia has been processed upon the suggestions of Ethical Committee. The Amendment entered into force on May 4th, 2006. More
Joint Declaration on the cooperation between the medical profession and the pharmaceutical industry
Slovak Medical Chamber and Slovak Association of Research Based Pharmaceutical Companies have come to an agreement and signed „Joint declaration on the cooperation between the medical profession and the pharmaceutical industry“.
The joint declaration deals with regulations of product information and promotion of approved medicines, sponsorship, clinical research, consulting services and relationship between medical profession and pharmaceutical industry. More
Up-dated version of Ethical Code of Pharmaceutical Industry in Slovakia is valid from April, 1st 2006
Since April, 1st 2006 up-dated version of Ethical Code of Pharmaceutical Industry is valid. The Code is divided into 2 parts: Ethical Code and Statute of Ethical Committee together with Operating Procedures of Ethical Code.
Ethical Code is prepared in accordance with standards of Ethical Code of EFPIA (The European Federation of Pharmaceutical Industries and Associations). Adherence of the Code is supervised by Ethical Committee. The Committee has nine members, six of them are representatives of member associations and three members are external – one is pharmacologist, one doctor with active practice and person emerging in the field of medical ethics. More
ADHERENCE OF ETHICAL PRINCIPLES IN PRIORITY
From October 2004, the pharmaceutical industry in Slovakia has a common Ethical Code and Ethical Committee.
Bratislava, 19 October 2004 – From October 2004, the pharmaceutical companies in the Slovak market have a common Ethical Code and Ethical Committee. It was promoted on the execution of a common declaration by the chairmen of three associations operating in the pharmaceutical industry: Association of Drug and health Devices Supplierrs Association (ADL); Association of Generic medicines Producers (GENAS) and Slovak Association of Research Based Pharmaceutical Companies (SAFS), which basically organize all of the pharmaceutical companies operating in Slovakia. More
Consumption and availability of medical drugs in Slovakia from the point of view of initiative G-10 of the European Commission on the need to maintain a stimulating economic space for innovation in Europe
Bratislava, July 14, 2004 – Availability of medical drugs is one of the most important topics for patients, doctors, pharmaceutical industry, insurance companies, as well as regulatory bodies. European Commission, which within a G-10 initiative deals with some principal issues related to the performance and prosperity of pharmaceutical industry in the European area in favor of the citizens of the European community, also considers it very important. Access to new drugs is not only important for producers, but also for doctors and patients who need these drugs. The G-10 initiative aims at speeding up the access of patients to new medicines, improvement of the supply system (flows of products within the common EU market) and the availability of new drugs in the sense of possible consumption. Access to new drugs also means access to better health for all European Union inhabitants. More
How much for hope?
Debates on the protection of intellectual property have appeared ever since the institute was introduced - not only in the area of research and development of drugs. Prices of new drugs, their effectiveness, and necessity are a frequent attractive topic because they relate to an area sensitive for all of us - health. More
Research and development of a drug in the legislative environment in the light of changes which will be brought about by Slovakia’s entry into the EU
Intellectual property plays an important role in the
pharmaceutical industry, because research and development
of original drugs is a very demanding process both in
terms of finance and time. Investments devoted to research
and development of new drugs must have a secured rate
of return. More
Enlargement of the European
Union - a challenge for pharmaceutical industry
Bratislava, April 30, 2003 - Negotiations between European
Federation of Pharmaceutical Companies and Slovak Association
of Pharmaceutical Companies in Bratislava. More
No generics without originals
Considering prices of original drugs it is necessary
to realise that although the economic aspect of this
issue is very important, we always have to study patient's
needs firstly. More
Drug Policy in Slovakia
At present SAFS associates 23 pharmaceutical
producers oriented to the research and development of
new drugs, operating all around the world (producers
of innovative - so-called osriginal drugs). Our objective
is with the utilisation of international experiences
in the area of drug policy to contribute to such solutions
that will lead in a short-term, but particularly a long-term
perspective, to the improvement of the situation in
Slovak health service. In this context we offer the
possibility of the regular cooperation and consultations
in all aspects of the drug policy. More
|
