Selected vfa articles in English language
The following points must be taken into account at European level:
- Better involve health technology developers
- Aim for common European evidence requirements
- Ensure lean processes and adapt to timeframes
- Create context-specific assessment methods
- Ensure capacity for scientific advice
Need for action
- Strengthen negotiations in the AMNOG process — abolish the anti-innovation "guard rails" of the GKV-FinStG and the combination discount
- Refine and evolve AMNOG for novel therapeutic approaches and the new European health technology assessment process
- Ensure reliable framework conditions to support Germany and Europe as hubs of innovative
research and production
Companies and research institutes are working on protective vaccines against the disease. Seven vaccines and four adapted variants of them have now been approved in the EU. Others could follow soon.
Germany has some strengths to show in the competition among locations for pharmaceutical R&D, but has nevertheless been falling behind internationally for some years. The study "Pharma-Innovationsstandort Deutschland" by Kearney and the vfa identifies key reasons for this, but also points to measures for reversing the trend. These include a roundtable on "Germany as a location for pharmaceutical innovation".
RNA technology is expected to play a major medical role in prevention and therapy in the future – and thus also a significant economic role. Germany has the best chances of playing an important role in this.
The definition of unmet medical need must remain comprehensive and unrestricted by additional gradations in order to address the diverse range of patients' unmet medi-cal needs. Rather than imposing restrictions, there should be more incentives for research and development to encourage innovation in Europe.
To date, two mRNA vaccines have been approved for vaccination against covid-19 worldwide, including in the EU. Many more are in development, also against other diseases. Here is an overview.
The recently published pharmaceutical package by the EU Commission raises concerns about its potential impact on research and development. Certain proposals for reforming the EU’s pharmaceutical legislation may have the unintended consequence of delaying patients' access to essential medicines and hindering efforts to foster innovation, thereby posing a risk to Europe's international competitiveness.
New active ingredients are invented in laboratories; often several laboratories are involved. A number of medicines developed in recent years contain active ingredients that were largely invented in German laboratories. This is shown in the following map.
Not only vaccines are being developed against the pandemic with the coronavirus SARS-CoV-2, but also medicines are being tested.
The vfa rejects the Commission's proposal for Extended Producer Re-sponsibility in the present form and proposes an alternative concept.
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.
The template is structured in five modules:
Module 1 contains a summary,
Module 2 contains general information about the new medicinal product,
Module 3 contains information on the patient population and cost analyses,
Module 4 is the core for the clinical assessment of the added...
Through consistency and more cooperation, EU HTA can provide faster access to new therapies. Implementation will be crucial to create real synergies and seize opportunities.
This year, three researchers have received the Nobel Prize in Chemistry for their pioneering work in the field of click chemistry and bioorthogonal chemistry. It is about the efficient linking of different molecular building blocks.
vfa research spokesperson Dr. Rolf Hömke reported in an interview with rbb Inforadio on July 16, 2022, on the status of omicron-adapted vaccine development.
The head of the EMA, Emer Cooke, expressed confidence in an interview with the Financial Times circulated Aug. 7, 2022, that her agency will...
The need for such an international pact arises, on the one hand, from the enormous damage caused by a pandemic: 6.3 million deaths worldwide, 530 million confirmed infections, consequential health damage (long covid) and, as a result of lockdowns, a sharp decline in economic output, disruption of...
Because vaccine production is one of the most demanding tasks in drug production. For this reason, cooperations that original manufacturers enter into with other competent companies are the logical way to rapidly expand production volumes.
The research-based pharmaceutical companies reject the abolition of patent protection, as research would be disincentivized and the problem of the still lacking production capacities would be aggravated.
Berlin (vfa). Within a week, one billion will become two billion in compulsory levies - this is what the current draft bill from the BMG provides for research-based pharmaceutical companies. vfa President Han Steutel says: "What a mess! When we hear from the Federal Minister of Health that we are to...
Given the large number of orphan diseases and because of the huge medical need for new therapeutic options especially for people with rare diseases, there is still a very great deal of work to be done in this area. vfa and vfa bio are strongly committed to rigorously promoting the development of new therapies for orphan diseases throughout the value chain.
vfa and vfa bio represent biopharmaceutical companies with proven expertise in research, development and production of biopharmaceuticals – original products and biosimilars. The competition among biopharmaceutical therapy options is an essential element in improving patient care. The use of biosimilars broadens the financial scope for the health care system, which in turn can be utilized for innovation pharmaceuticals.
The Covid 19 pandemic continues unabated in large parts of the world. New variants of the pathogen, the SARS-CoV-2 coronavirus, continue to emerge, also known as mutants. They have slightly altered proteins, which in some cases makes them even more contagious. Fortunately, vaccination with the...
Germany has a well-balanced regulatory framework for drug evaluation and reimbursement that gives patients access to innovative drugs faster than in other countries. In fact, Germany tops the European rankings on this score. Medicines are immediately and reliably reimbursed by health insurers in this country as soon as approved. In parallel, the new medicines undergo AMNOG benefit assessment and price negotiations.
The point is not to destabilize this established system, but to improve it with the measured input of all stakeholders. The main objectives must be to em-power innovation, strengthen the focus on delivering quality health care, and improve processes.
The WHO programme is primarily responsible for purchasing doses of vaccine from manufacturers and allocating them to all countries that have declared their participation, regardless of their purchasing power.
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.
The highly complex production of biopharmaceuticals is an area where Germany can make out its strengths. In terms of the number of active ingredients produced, Germany is the leader in Europe and ranks second worldwide. This favorable position should not be jeopardized by short-term cost-cutting measures such as those planned for biosimilars with automatic substitution in pharmacies planned as of 2022.
The safety review of Covid 19 vaccines does not end with their approval, but continues thereafter. How this is done is explained here.
The WHO program is primarily responsible for purchasing vaccine doses from manufacturers and allocating them to all states that have declared their participation, regardless of their purchasing power.
Never before has the public focus on medical biotechnology companies been as strong as since the beginning of the Covid 19 pandemic. However, medical biotechnology in Germany also plays an important role in medical progress, regardless of the acute pandemic situation.
For some years now, not only doctors and pharmacists have been able to report suspected cases of side effects, but also the users of medicines themselves. To do so, they have a choice of several routes, all of which lead to the EU's large database of adverse reactions.
The new biotech report describing the situation of medical biotechnology in Germany is now available. The focus of this year’s report is on the benefit of biopharmaceuticals for patients with autoimmune diseases.
By the end of Germany's ‘National Decade against Cancer’, cancers will be better controlled. Cancer patients will have much longer survival rates with a good quality of life. The goal of a cure is achieved in increasing numbers of cases.
Cancer prevention and screening that reduces the risk...
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).
How to recognise the new packages:
They have a tamper-evident feature, i.e. a closure that shows if anyone has opened it before. It may be an adhesive seal across the opening flap of a pack which, following removal, tears off some of the ink of the pack. Or the pack must be opened along a line...
In future, prescription medicines need packaging that cannot be opened and closed without leaving a trace. This ensures that possible manipulations of the content do not take place or are noticeable. There is, after all, the potential risk that criminals get hold of an original pack, exchange the...
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.
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.
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.
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.
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.
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.
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.
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.
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.
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),...
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.
For the first time, recommendations on model clinical trial agreements has been published. They are intended as a non-binding guide and starting point for the practical negotiation of contracts between all organizations in Germany participating in the conduct of a study.
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.
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.
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.
Eradicating hunger and combating disease are at the heart of overseas development policy. And they are linked in several ways.
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)...
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.
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.
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...
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.
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.