Pharmaceutical manufacturer
Pharmaceutical manufacturers (also known as pharmaceutical companies and collectively known as the pharmaceutical industry or pharmaceutical industry ) are entrepreneurs or companies that manufacture drugs . The spectrum of activities includes research and development for new active ingredients and dosage forms , the manufacture of pharmaceuticals ( original preparations or generics ) and the placing on the market under one's own name (as authorization holder or as co-distributor).
Business models
In general, pharmaceutical manufacturers can be divided into two groups: original and generic manufacturers.
The original manufacturers (see also original preparation ) are also referred to as research-based manufacturers and are characterized by pharmaceutical research and the development of new drugs. As a rule, original manufacturers specialize in selected indication areas in which they are market leaders . They typically invest heavily in branding and sales.
Generic manufacturers , on the other hand, usually do not conduct any research, but use active ingredients for which patent protection has already expired. Due to the low research and development costs, it is possible for generic drug manufacturers to offer drugs of the same quality at significantly lower prices than the research-based manufacturers. Most generic manufacturers appear on the market as full-range suppliers and offer as many different active ingredients as possible.
In many cases, original manufacturers work with subsidiaries that produce generics or cooperate with external generics manufacturers in order to improve the value-added cycle of their active ingredients.
Manufacturers of biosimilars are breaking through the classic distinction between business models. The by-products of biopharmaceuticals whose patent protection has expired are not generics in the traditional sense. Since they are not identical to the original preparation, they are not subject to the aut-idem principle (same active ingredient), but rather the aut-simile principle (similar active ingredient). The biosimilar manufacturers must therefore carry out numerous studies before approval, which is why they are sometimes referred to as research-based generic manufacturers .
Products
The product range of the pharmaceutical companies includes a wide variety of drugs for both human and veterinary medicine : such as finished drugs , blood preparations , serums , vaccines , in vivo diagnostics , allergen preparations and drugs for novel therapies (for example, gene therapeutics , somatic cell therapeutics , biotechnologically processed tissue products ).
Medicines do not include medical devices such as B. bandages , catheters , in-vitro diagnostics or artificial joints, even if some of these are manufactured by pharmaceutical companies.
Medicines are either manufactured by the pharmaceutical company themselves, but can also be produced by contract manufacturers (English. Contract Manufacturing Organization ).
Legal
Pharmaceutic entrepreneur
The German Medicines Act defines a pharmaceutical company as an entrepreneur who is the owner of the authorization or registration for medicinal products that are subject to authorization or registration or who markets medicinal products under his name.
According to the Austrian Medicines Act , a pharmaceutical company is an entrepreneur based in a contracting party to the EEA Agreement who is authorized to market, manufacture or wholesale medicines under his name.
Pharmaceutical companies are subject to special drug law obligations (implementation of a pharmacovigilance - and risk management systems, quality management system in accordance with the Good Manufacturing Practice , preclinical and clinical trials ) to improve the quality, effectiveness and safety to ensure their products.
Drug manufacturing
The German Medicines Act defines manufacturing processes as follows: “Manufacturing is the extraction, manufacture, preparation, treatment or processing, transferring including filling, packaging, labeling and approval; The mixing of finished medicinal products with feed by the animal keeper for direct administration to the animals kept by him is not considered to be manufacturing. "
Pharmaceutical companies require an official permit (manufacturing permit ) in accordance with Article 40 Paragraph 1 of Directive 2001/83 / EC or Section 13 of the German Medicines Act for the production of medicinal products or certain medicinal substances.
The market entry for generics is restricted by various legal norms, see Generic # Legal barriers for the market entry of generics .
Lists of the largest pharmaceutical manufacturers
Global
2014
Source: PharmExec
1995
| Rank 1995 | Companies | 1995 sales (billion $) |
|---|---|---|
| 1 | Novartis | 9.7 |
| 2 | Glaxo Wellcome | 9.6 |
| 3 | Maximum | 7.8 |
| 4th | MSD | 7.7 |
| 5 | Bristol-Myers Squibb | 6.8 |
| 6th | American Home Products | 6.5 |
| 7th | Johnson & Johnson | 6.2 |
| 8th | Pfizer | 6.1 |
| 9 | Hoffmann-La Roche | 5.7 |
| 10 | SmithKline Beecham | 5.5 |
1980
| Rank 1980 | Companies | 1980 sales (billion $) |
|---|---|---|
| 1 | Maximum | 1.6 |
| 2 | Ciba-Geigy | 1.4 |
| 3 | MSD | 1.4 |
| 4th | American Home Products | 1.2 |
| 5 | Hoffmann-La Roche | 1.2 |
| 6th | Smith Kline | 1.1 |
| 7th | Boehringer Ingelheim | 1 |
| 8th | Sandoz | 1 |
| 9 | Pfizer | 1 |
| 10 | Bristol-Myers | 0.9 |
According to sales in Germany
Top 10 in Germany (2015)
According to IMS Health , the following pharmaceutical manufacturers were among the top 10 in Germany in 2015 (according to sales of prescription drugs on the German market, sorted in descending order):
Pharmaceutical associations
International
The most important global umbrella organization is the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). Some of the world's largest pharmaceutical companies are organized in it. In the USA, Pharmaceutical Research and Manufacturers of America (PhRMA) is the most influential association in which not only large corporations, but also biotechnology companies are organized. In Europe, the European Federation of Pharmaceutical Industries and Associations (EFPIA) is an umbrella organization for national pharmaceutical associations. PhRMA and EFPIA are also founding members of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), in which, together with the responsible pharmaceutical authorities, essential aspects of drug approval between the European Union, the USA and Japan were harmonized. European parallel trade is specifically represented by the EAEPC ( European Association of Euro-Pharmaceutical Companies ). Another European umbrella organization for pharmaceutical companies is the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE). The interests of the manufacturers of OTC drugs are represented at the European level by the Association of the European Self-Medication Industry (AESGP) and at the international level by the World Self-Medication Industry (WSMI).
In Germany
The pharmaceutical manufacturers in Germany are organized in a number of associations. Many medium-sized companies belong to the Federal Association of Drug Manufacturers (BAH) with the largest number of members . Under the umbrella of the Association of the Chemical Industry , the manufacturers of prescription drugs are organized in the Federal Association of the Pharmaceutical Industry (BPI) and in the Association of Research-Based Pharmaceutical Manufacturers (VFA). The VFA also represents German companies in the European umbrella organization EFPIA. Generics manufacturers are organized in the Pro Generika Association, which also includes a working group for biosimilars manufacturers (AG Pro Biosimilars). Various companies and associations are members of the voluntary self-regulation for the pharmaceutical industry and are subject to its codes of conduct to monitor cooperation with specialist groups and patient organizations.
In Switzerland
Interpharma represents the interests of research-based pharmaceutical companies in Switzerland.
In Austria
The Pharmig represents some 120 companies from the pharmaceutical industry in Austria. In addition, almost 30 international pharmaceutical companies with research and development in Austria came together to form the Forum of the Research-Based Pharmaceutical Industry (FOPI).
Employees
Germany
The pharmaceutical industry in Germany has around 114,000 employees (as of 2015).
Development:
- 1995: 122,900 employees
- 1996: 120,776 employees (−1.7%)
- 1997: 115,298 employees (−4.5%)
- 1998: 113,914 employees (−1.2%)
- 1999: 113,029 employees (−0.8%)
- 2000: 113,950 employees (+ 0.8%)
- 2001: 114,267 employees (+ 0.3%)
- 2002: 114,990 employees (+ 0.6%)
- 2003: 118,720 employees (+ 3.2%)
- 2004: 113,989 employees (−4.0%)
- 2005: 113,002 employees (−0.9%)
- 2006: 113,234 employees (+ 0.1%)
- 2010: 103,208 employees (−4.6%)
- 2011: 105,435 employees (+ 2.2%)
- 2012: 110,006 employees (+ 4.3%)
- 2013: 110,036 employees (+ 0.1%)
- 2014: 112,475 employees (+ 2.2%)
- 2015: 114,069 employees (+1.4%)
- 2020: 119,994 employees
Switzerland
In 2014, a total of around 41,800 employees were directly employed by pharmaceutical companies, which corresponds to a good 1% of all Swiss employees. Indirectly, another 182,000 people were employed in the production of intermediate inputs via supplier industries.
Austria
In 2017, around 28,850 people were employed by biotechnology and pharmaceutical companies in Austria (research and development, production, suppliers, service companies, sales).
criticism
The influence of pharmaceutical companies on medicine , academic pharmaceutical research and public opinion - and, as a result, expectations regarding the use or prescription of drugs - is viewed by some critics as problematic, and their influence is viewed as problematic by medical and industry insiders - such as Chief Detective Uwe Dolata , Peter C. Gøtzsche , Peter Sawicki or John Virapen - often described as “all-encompassing” or “organized criminal”. The criticism results, among other things, from the following context: The greater the financial and other interests in a scientific area, the less likely it is that the research results are true ( positive predictive value decreases).
Methodology and target groups of influence by pharmaceutical companies
The Frontal21 - Documentation Das Pharmakartell by Christian Esser and Astrid Randerath (ZDF, 2008) criticizes based on interviews with critical insiders such as Bruno Müller-Oerlinghausen , Uwe Dolata , Peter Schönhöfer , Leonhard Hansen ; John Virapen and Wolf-Dieter Ludwig use criminal methods. This includes the concealment of serious and fatal side effects for up to decades , the disappearance or non-publication of unacceptable study data or blackmailing of those who know it .
In addition to attempts at bribery, there are also threats of violence against decision-makers ( e.g. within the Association of Statutory Health Insurance Physicians , as reported by Leonhard Hansen , or in the IQWiG institute ) as well as the corruption of politicians, doctors and health professions and, in some cases, self-help groups themselves . According to Peter Schönhöfer , co-editor of the Arznei-Telegram , “ rent mouths ” would “sell drugs and their side effects in abundance”. Purchased medical luminaries , especially professors, are targeted by the pharmaceutical industry in the area of the German “eminence belt” - so the “pharmaceutical jargon” according to the author Gunter Frank . Purpose used. According to research by the authors of Das Pharmakartell, near- patient health magazines such as the Apotheken Umschau would also be corrupted and would therefore publish unchecked representations of the drugs as “professional advice” in accordance with the specifications of the industry, in which such “experts” would sometimes be “accommodated”.
Criticism of high marketing expenses
In public, representatives of the pharmaceutical companies on the one hand often emphasize their function as "research-based pharmaceutical manufacturers", which would result in high costs , for example , and continue to do so due to active ingredients that have to be purchased. The reality - based on figures published by the corporations - appears in a different light. According to the medical journalist and author Hans Weiss on Deutschlandradio Kultur, spending on research amounts to around 15 percent of sales, while marketing costs 50–55 percent, that is: "more than three times as much" . Accordingly, the prices would be “in no relation to the research expenditure”. In the case of the cancer drug Taxol from the manufacturer Bristol-Myers Squibb , for example, “a pack of an infusion would cost 676.70 euros”, with the proportion of the active ingredient costs at the external active ingredient manufacturer being “just one euro” according to his research. Overall, despite the highest marketing expenditure, there is “no industry” that “makes as high profits as that”. 20 to 30 percent of sales are "pure profit".
Corruption and influencing of control authorities
Critics criticize the supposed practice of pushing high-risk products onto the market or keeping them there, which on the one hand results in high numbers of deaths and serious damage, as well as frequent withdrawals after approval and market launch . This is possible through financial influence and bias of decision-making authorities with regard to the classification of infectious diseases as z. B. epidemics or pandemics or on the other hand drug authorities when approving their preparations. Transparency International Germany warns that national and international control authorities for pandemics are now under the influence of the pharmaceutical industry.
"Diverse interdependencies between the WHO pandemic experts and the drug and vaccine manufacturers" are the cause of the inexplicable and almost identical negligence of numerous Europe-wide approval and control authorities, who were content with "incomplete study data" on the part of the corporations. In fact, the alleged antiviral efficacy of the drugs sold to numerous governments is "not detectable in the full study data". Likewise, the alleged pandemics were actually not - as had been predicted by "independent scientists". As a result - apart from the risk of adverse drug effects - "the storage of unnecessary and unsuitable antiviral drugs on the occasion of the pandemic false alarms 2005 and 2009" would have cost Germany "budget funds in the three-digit million range" ( pandemic plans by the federal government and federal states with oseltamivir ( Tamiflu®) and Zanamivir (Relenza®), costs of 330 million euros). “In the event of a new pandemic alert”, Transparency International therefore demanded, among other things, a “neutral scientific assessment”.
Transparency International Germany refers to the Cochrane Collaboration and the British Medical Journal , which provides detailed information on this and put all its correspondence with Roche online as part of an "Open Data Campaign". The Süddeutsche Zeitung and the Tages-Anzeiger also reported extensively on it. According to the Tagesanzeiger , “detailed documentation” shows how the “health authorities around the globe” were “satisfied with incomplete documents from the pharmaceutical company” when they bought Tamiflu for “billions of taxpayers' money”.
Bias and influence on medical research and universities
Conflicts of interest ( bias ) are not uncommon in medical research and can call the integrity of research into question. German universities are also affected by the influence: from the commercial sector - including pharmaceutical companies - more than 1.3 billion euros flow to German universities every year (twice as much as ten years ago). The TAZ , the anti-corruption organization Transparency International Germany and the nationwide student union “ Free Association of StudentInnenschaften ” (FZS) demand that all cooperation agreements between business and science be published as well as regular sponsorship reports from all universities.
Further criticisms
- A Canadian study from 2007 found that US pharmaceutical companies spend more money on advertising than on research - in 2004 € 39.3 billion were invested in advertising and € 21.5 billion in research and development. They cite market research institutes and the American National Science Foundation as sources .
- The fact that pharmaceutical companies do not always work properly with regard to their sales is shown by high fines, especially in the USA. According to the Handelsblatt , the pharmaceutical company GlaxoSmithKline announced additional charges of 400 million US dollars (312 million euros) as a result of investigations into unauthorized distribution methods. The big pharmaceutical companies Pfizer and Eli Lilly had previously announced high provisions. Pfizer has agreed to a settlement that will result in a record $ 2.3 billion fine. Eli Lilly was fined $ 1.4 billion in January 2009.
- In 2008, the EU Commission initiated an investigation into the conditions that may distort competition in the pharmaceutical sector. The aim should be to find reasons why at that time fewer new medicines to the European market came (1995-1999 new, on average 40 molecular entities per year from 2000 to 2004, however, only 24) and the introduction of cheaper is why generics in the length pulled . The investigation was initiated on the basis of European competition law. The final report for 2009 came to the conclusion, among other things, that companies that hold the patent rights are using a wide variety of strategies and measures to maintain cash flows through the drug trade. These practices can delay the introduction of generic drugs, causing consumers to pay more. The instruments included: strategic patenting, indictments of patent infringements against generic drug producers, but also agreements with generic drug producers, as well as manipulation of national authorities and long-term planning for market domination through the introduction of successor drugs. This approach cost the health insurers around 3 billion euros in the examined sample alone between 2000 and 2007. A monitoring program is in progress regarding agreements in the event of patent disputes.
See also
- pharmacy
- List of high-profile incidents related to the development, marketing or use of pharmaceuticals
- Pharmaceutical consultant
- Pharmaceutical wholesaling
- Pharmaceutical representative
literature
- Dagmar Fischer, Jörg Breitenbach: The pharmaceutical industry: insight - perspective - perspectives. 4th edition. Springer Spectrum, Berlin / Heidelberg 2013, ISBN 978-3-8274-2923-0 .
- Wolf-Dieter Müller-Jahncke , Christoph Friedrich : History of drug therapy . Deutscher Apotheker Verlag, Stuttgart 1996, ISBN 3-7692-2038-2 .
Web links
Individual evidence
- ↑ a b c d Hermann Hofmann, Oliver Schöffski: Generics and Biosimilars . In: Oliver Schöffski, Frank-Ulrich Fricke, Werner Guminski (Eds.): Pharmabetriebslehre . 2nd Edition. Springer, Berlin / Heidelberg 2008, ISBN 978-3-540-79550-6 , pp. 397-412, here p. 398.
- ↑ Hermann Hofmann, Oliver Schöffski: generics and biosimilars . In: Oliver Schöffski, Frank-Ulrich Fricke, Werner Guminski (Eds.): Pharmabetriebslehre . 2nd Edition. Springer, Berlin / Heidelberg 2008, ISBN 978-3-540-79550-6 , pp. 397-412, here p. 399.
- ↑ Law on the Marketing of Medicinal Products, Section 4 (18)
- ↑ Federal Act on the Manufacture and Marketing of Medicinal Products (Medicines Act), Section 2 (13a)
- ↑ Law on the Marketing of Medicinal Products, Section 4 (14)
- ^ Taking Flight: Pharm Exec's Top 50 Pharma Companies . PharmExec, July 14, 2015 (English).
- ↑ Global top 10 pharmaceutical companies 1980–2011 , p. 24
- ↑ Kirsten Sucker-Sket: The pharmaceutical companies with the highest sales in Germany: Gilead and AbbVie oust Stada . In: Deutsche Apotheker Zeitung , February 25, 2016, accessed on June 28, 2017.
- ^ Website of the forum of the research-based pharmaceutical industry in Austria. Retrieved October 17, 2019 .
- ↑ Pharma data - important facts about the industry and health care at a glance , on the website of the Federal Association of the Pharmaceutical Industry (BPI).
- ↑ Kirsten Sucker-Sket: "Pharmaceutical manufacturers are stability anchors for Germany and Europe". In: Deutsche Apotheker Zeitung. June 3, 2020, accessed June 14, 2020 .
- ↑ The increasing importance of the pharmaceutical industry as an employer , at www.interpharma.ch, accessed on October 29th
- ↑ Life Science Report Austria 2018. Retrieved on October 17, 2019 (English).
- ↑ Gunter Frank: Bad medicine. A rage book. 3. Edition. Knaus-Verlag, 2012, ISBN 978-3-8135-0473-6 , pp. 70–79 and in total.
- ↑ Klaus Hartmann: Vaccination until the doctor comes. When pharmaceutical companies make profit over health. 1st edition. Herbig, 2012, ISBN 978-3-7766-2694-0 .
- ↑ Hans Weiss: Corrupt Medicine. Kiepenheuer & Witsch, Cologne 2008.
- ↑ Sawicki criticizes the pharmaceutical lobby. ( Memento of the original from April 24, 2015 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. In: Deutsches Ärzteblatt. January 26, 2010, ärzteblatt.de about the former head of the Institute for Quality and Efficiency in Health Care (IQWiG), Peter Sawicki.
- ↑ Peter C. Gøtzsche : Deadly Medicine and Organized Crime: How the Pharmaceutical Industry Corrupts Our Health Care System. Riva, Munich 2014, ISBN 978-3-86883-438-3 .
- ^ GA Jelinek, SL Neate: The influence of the pharmaceutical industry in medicine . In: Journal of Law and Medicine . tape 17 , no. 2 , October 2009, p. 216-23 , PMID 19998591 ( PDF ).
- ^ The influence of the pharmaceutical industry. (PDF) House of Commons Health Committee, Fourth Report of Session 2004–2005, Volume I, March 22, 2005, accessed December 2, 2018 .
- ^ John Ioannidis : Why Most Published Research Findings Are False . In: PLoS Medicine . tape 2 , no. 8 , March 19, 2017, p. e124 , doi : 10.1371 / journal.pmed.0020124 , PMID 16060722 , PMC 1182327 (free full text).
- ↑ a b Leonhard Hansen on Arztwiki.de ( Memento from February 20, 2015 in the Internet Archive )
- ↑ Drugs Commission of the German Medical Association - Scientific Committee of the German Medical Association, short biography: Prof. Dr. med. Wolf-Dieter Ludwig , accessed on February 17, 2015.
- ↑ Gunter Frank: Bad Medicine - Ein Angerbuch . 3rd edition Knaus, 2012.
- ↑ "There is no industry that makes such high profits - medical journalist Weiss about the pharmaceutical industry and drug prices". Hans Weiss in conversation with Joachim Scholl. March 12, 2010, Deutschlandradio Kultur, accessed on February 27, 2015.
- ↑ The storage of unnecessary and unsuitable antiviral drugs on the occasion of the pandemic false alarms in 2005 and 2009 cost Germany budget funds in the three-digit million range , press release of February 13, 2015, accessed on December 2, 2018.
- ↑ Tamiflu: the battle for secret drug data In: British Medical Journal. 2012, vol. 345, e7303, doi: 10.1136 / bmj.e7303 .
- ↑ a b F. Godlee, M. Clarke: Why do not we have all the evidence on oseltamivir? In: BMJ. Vol. 339, 2009, pp. B5351-b5351, doi: 10.1136 / bmj.b5351 .
-
↑ Tamiflu correspondence with Roche
Tamiflu correspondence with the World Health Organization
Tamiflu correspondence with the Centers for Disease Control and Prevention
Correspondence with the European Medicines Agency - ↑ The Tamiflu scandal - blind trust in the dubious flu drug, cover page on the topic on Süddeutsche.de , accessed on February 17, 2015.
- ↑ Doubts about Tamiflu - The pressure on Roche is increasing. In: Tages-Anzeiger , January 26, 2013 (viewed online on January 28, 2013).
- ^ Bernard Lo: Serving two masters - conflicts of interest in academic medicine . In: New England Journal of Medicine . tape 362 , no. 8 , February 2010, p. 669-71 , doi : 10.1056 / NEJMp1000213 , PMID 20181969 .
- ↑ SN Young: Bias in the research literature and conflict of interest: an issue for publishers, editors, reviewers and authors, and it is not just about the money . In: J Psychiatry Neurosci . tape 34 , no. 6 , November 2009, p. 412-7 , PMID 19949717 , PMC 2783432 (free full text).
- ↑ PRESS RELEASE: Universities are receiving more and more third-party funding from industry - the Internet portal Hochschulwatch.de takes stock. , Transparency International Deutschland eV, February 17, 2015, accessed on December 2, 2018
- ↑ Hochschulwatch - power, economy, university . Retrieved December 2, 2018 . , hochschulwatch.de, an initiative of Transparency International Germany; Free association of student bodies (FZS) and “die Tageszeitung” (TAZ), accessed on February 17, 2015.
- ↑ New internet portal hochschulwatch.de collects examples of questionable connections between business and science . fzs.de, January 24, 2013, accessed December 2, 2018 .
- ↑ Current: Hochschulwatch Relaunch - Macht, Wirtschaft, Uni ( Memento from March 3, 2015 in the Internet Archive ), fzs.de, accessed on February 17, 2015.
- ^ Spiegel Online: More money for advertising than for research , January 3, 2008.
- ↑ Record buses for the pharmaceutical company Pfizer. In: Neue Zürcher Zeitung. September 3, 2009, accessed March 20, 2010 .
- ↑ Official website of the EU: FAQ on the preliminary investigation into the conditions that may distort competition in the pharmaceutical sector of 28 November 2008.
- ↑ Official website of the EU: FAQ on the preliminary investigation into the conditions that may distort competition in the pharmaceutical sector of 16 January 2008.
- ↑ Official website of the EU: Fact sheet on the preliminary report on the conditions that may distort competition in the pharmaceutical sector (PDF; 29 kB).
- ↑ Official website of the EU: Overview website to investigate the conditions that may distort competition in the pharmaceutical sector
