Selected vfa-articles in english language

vfa and vfa bio, representing biopharmaceutical companies with and without biosimilar activities, are committed to competition between biopharmaceutical therapy options so as to improve health care for patients. We advocate for general conditions for the quality-assured use of bio-pharmaceuticals - original products and biosimilars:

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Antibiotics – medicaments against harmful bacteria – are among the greatest achievements of medicine. It is thanks to them that lung infections, wound infections, scarlet fever, syphilis and many other diseases have lost their terror. Thus, today in Germany, bacterial infections rank far behind cardiovascular diseases and cancer as causes of death.

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In some African countries, hospitals live in constant fear that they are being supplied with fake medicines. If this remains unnoticed, patients are at risk. However, if it is recognized, those who have exposed the fake are at risk. After all, people who falsify medicines or sell such medicines with intent have no respect for human life. This is why an alarm network in which church-affiliated hospitals in 11 African countries give each other warnings of falsified products, never publish the hospital where the fake was detected. This was reported by Dr. Gisela Schneider, Director of the German Institute for Medical Mission (DIFAEM) at the workshop “Falsified and Sub-Standard Medicine – Initiatives and Activities to Secure Access to High Quality Medicines“ at the World Health Summit, a meeting of experts on global health which took place in Berlin from October 14 - 16. The workshop was hosted by vfa. Over 100 visitors attended the summit including African health ministers and doctors, health consultants, representatives of health organizations and companies.

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As soon as the patent protection of a biopharmaceutical drug ends, follow-on products, so-called “biosimilars”, are allowed to enter the market. Competition between different biopharmaceuticals for prescriptions in the same field of application is essential to improve patient care. Hence, the market launch of biosimilars can provide the health care sector with financial breathing space. In order to ensure the quality-approved use of biopharmaceutical it is however imperative that doctors retain their freedom to decide which patients receive what drug.

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Every month, 45 million packs of medicinal products make their way from the UK to the EU, while 37 million packs make their journey in the opposite direction across the Channel. There are no other figures that demonstrate so well the close interdependence between Great Britain and the other EU Member States. The United Kingdom is a particularly important global player in the pharmaceutical sector. Accordingly, its standing still remains high within the EU. A visible sign of this is the location of the European authorization authority EMA in London. But this is in the process of change. Following the Brexit vote by the British people, the European Medicines Agency has to relocate to Amsterdam in March 2019.

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Some of the infectious diseases that affect above all the poor in emerging and developing countries are referred to as "Poverty-associated, neglected tropical diseases (NTDs)". While they claim fewer deaths there than the "Big Three" (malaria, tuberculosis and HIV/AIDS), they still cause a great deal of suffering. Their geographical distribution is not always limited to the tropics.

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In the EU, a disease is called “rare” if no more than 5 out of 10,000 EU citizens (in other words: one out of 2,000 EU citizens) suffer from it. Nevertheless, it is not infrequent to come across a patient who suffers from one or another rare disease; the organization “Eurodis – Rare Diseases Europe“ estimates that 6 to 7 percent of the EU population are affected, pointing out that it is not just the patients themselves who suffer but also their families and friends.

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Nineteen out of forty-two member companies of the German Association of Research-Based Pharmaceutical Companies (vfa) are currently running laboratories to research active ingredients or galenics in Germany. Every year they spend around 5.5 billion euros on research and development (R&D) in Germany alone, equaling a daily spending rate of 15 million euros. This shows that for internationally active pharmaceutical companies Germany is one of the leading research locations.

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The current Biotech Report on the situation of medical biotechnology in Germany that has been produced for vfa by The Boston Consulting Group is now available. This is the only annually published report that includes all activities in the field of medical biotechnology in Germany, from start-ups to large companies. Apart from the 2017 key economic indicators in medical biotechnology in Germany, this year’s report focuses on the production of biopharmaceuticals as well as their benefit for patients with metabolic disorders.

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The digital transformation in culture, society and business is more than technological progress. It is a fundamental transformation process - even for our health system. It offers opportunities but also challenges. Yet, it can become a success story through cooperation, an open attitude towards innovation and political support.

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Falsified medicines represent a risk for the user even if there have only been individual cases of smuggling into regular pharmaceutical distribution so far. The distribution system is already being protected by a number of measures against falsified products. However, to provide an even better level of protection against this risk in the legal supply chain, an IT-based verification system is currently being implemented across the EU in which prescription medicines need to be checked for authenticity again, directly before the handover to the patient. The German part of this system is being set up by securPharm e.V., an alliance of associations in the pharmaceutical industry (vfa, BPI, BAH), pharmaceutical wholesalers (PHAGRO) and pharmacists (ABDA).

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Science20 Dialogue Forum

The science academies of the G20 countries met earlier on in March 2017 focusing on the topic of global health care in their recommendations to their countries’ governments. Under the auspices of the Leopoldina Akademie der Wissenschaften (German Academy of Sciences),...

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German industrial laboratories have been involved in the discovery of a whole range of drugs that have come onto the market in recent years: either the active ingredient was discovered in Germany or its pharmaceutical form was developed in German laboratories or even both took place in laboratories here.

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Diseases do not recognize European national borders, so why should the benefit assessment? Does someone living in Portugal have different disease symptoms from someone living in Germany? Hardly! So why should the benefit assessment be governed by a European's nationality? Certainly, there is a difference in cost of living between Germany and Portugal. So, there is some point in differentiating according to nationality when it comes to price negotiations but not as far as the medical assessment is concerned.

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Since ancient times, herbs and plant extracts have been used as a proven means of alleviating pain or healing certain diseases. But only in the last 120 years have pharmaceutical researchers been able to develop ever more effective medicines specifically based on individual active ingredients....

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Drugs are an important part of health care provision. This becomes particularly obvious when a drug that is about to be used is suddenly unavailable. In their own interest manufacturers are doing their utmost to be able to supply their customers at all times if possible. And if, despite everything, supply problems occur, they endeavor to overcome them as soon as possible. But, as in the case of other technically manufactured products, even in the world of drugs one cannot always prevent scenarios where the quantities required are temporarily unavailable.

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Erstmals sind Empfehlungen zur Vertragsgestaltung bei klinischen Prüfungen veröffentlicht worden. Sie sind als Orientierung und Ausgangspunkt für konkrete Vertragsverhandlungen zwischen allen an einer Studiendurchführung beteiligten Institutionen gedacht.

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On October 12, 2017, the "Prizes to promote research methods to replace or complement animal experiments" were awarded for the fourth time by the State of Berlin. The prizes were sponsored by the German Association of Research-Based Pharmaceutical Companies (vfa) and the Berlin Veterinary Association. The awards went to projects on animal-free identification of flu viruses and the development of a platform that uses brain tissue produced from human stem cells as a model for research into stroke disease. The prizes are worth a total of 25,000 euros.

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Medicines that are intended for men and women are also tested on men and women. This is a requirement of the licensing authorities and German law. Study results for both genders are compared and are also included in the early benefit assessment that each new medicine in Germany must undergo.

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There has been a recent shake-up in the field of publication of clinical study results: EU and US organizations, even pharmaceutical companies, have all implemented or announced plans to expand their publishing practices.

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Hardly any other product goes through more checks and controls during manufacture than a medicinal product. This certainly applies when all the production steps take place at the same company but even more so when several production concerns are involved – for example, a sub-supplier that synthesizes the substance and a pharmaceutical company that uses this substance to manufacture the finished medicine. A whole range of controls ensure that the quality is good and that pharmaceutical companies do not have any counterfeit products pushed on them.

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Eradicating hunger and combating disease are at the heart of overseas development policy. And they are linked in several ways.

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The tiny pieces of skin in the red nutrient solution are only the size of a fingernail. Yet in the future they could help to eliminate the need to test chemicals and drugs on guinea pigs and mice. For the development of his novel skin model, Professor Dr. Günther Weindl (Free University of Berlin)...

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The German Bundestag is implementing a number of pharmaceutical policy changes within the scope of the 14th law amending Book V of the German Social Code.

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When the legislature created the Act on the Restructuring of the Pharmaceutical Market (AMNOG), it has established a process that is as complex as it is complicated, and in some places it is questionable from a methodological standpoint. To facilitate an easier categorization of individual aspects of the procedure, we have developed an interactive information graphic in cooperation with ÄrzteZeitung that illustrates the process of the early benefit assessment, including the parties involved and the resulting problems and conflicts.

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In contrast to most other European countries, Germany’s economy performed very well in 2011. As a result, the social security funds – especially the health fund – are well funded and show surpluses. Due to the uncertainties induced by the European financial crisis, however, and the new...

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Ways to achieve health care savings are currently being discussed. Governmental policy and the health insurancers plan to create these savings primarily by way of prescription drugs. Legislative decisions should be based on facts. Here are some facts regarding prices and spending on medicines in Germany.

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Europe is in the lead when it comes to vaccines: This area covers two-thirds of industrial research and development activities, 60 percent of the employees and even 90 percent of worldwide production. A total of 84 percent of the European production is exported, half of it for humanitarian projects in developing countries.

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