Supply of medicinal products in Switzerland “Out-of-stock requests are processed promptly when supply problems arise.”

Andreas Pfenninger heads the Stakeholder Engagement Division at Swissmedic. In other words, he coordinates the national and international activities – including those relating to the security of supply of medicines and vaccines in Switzerland. For Visible he presents the possible lifecycle of an antibiotic – including the potential supply bottlenecks.

General situation

"Problems due to supply bottlenecks and disruptions have been with us for a long time. The situation first came to a head around ten years ago. Since then, supply problems have escalated over the past three or four years and been experienced not just by stakeholders in healthcare but also by the general public. People have been tackling the supply situation and possible bottlenecks on a wide variety of levels. The situation has been further exacerbated by the coronavirus pandemic."

Antibiotics, for example: The initial phase

"The lifecycle of a medicine always follows a similar course. Let's take an antibiotic: It is first developed by a company. The company then applies for a patent for the active substance, usually for 20 years. So once development is concluded, the company has the exclusive right to market the product/preparation/active substance for eight to ten years. At the same time, the company must ensure that it is able to supply the market; consequently, supply bottlenecks rarely affect patent-protected medicines. When the patent expires, other manufacturers are allowed to market generics, i.e. medicines containing the same active substance. This often leads to a reduction in the sales price. At this point, the patent holder has to decide whether to withdraw its product from the market or continue producing the original product."

Antibiotics, for example: The consolidation phase

"If the market for the antibiotic is attractive, a wide range of suppliers and products becomes available once the market is opened up. The antibiotic booms and supplies are available. However, the older the product, the less it is manufactured. On the one hand, newer, better products emerge while, on the other, the manufacture of the older product is no longer cost-effective. This leads to a market shake-out, what is known as the consolidation phase."

Antibiotics, for example: possible bottlenecks

"When the consolidation progresses to the point where just one manufacturer remains at the end of the lifecycle, supply bottlenecks can occur. In the event of a quality defect, for example, the necessary quantities of the preparation cannot be produced. But unforeseen events such as a pandemic with a lockdown, or an earthquake or fire that destroys the manufacturing plant, can also be the cause of bottlenecks."

Antibiotics, for example: out-of-stock requests

"If the antibiotic can no longer be sourced in Switzerland, the marketing authorisation holder can submit an out-of-stock request to Swissmedic with the aim of importing, and temporarily distributing, an identical preparation from another European country. Such requests are processed promptly, and the comparable products can be repackaged in Switzerland or supplemented with a label and a Swiss package leaflet and then sold. This repackaging or new labelling is required to ensure patient safety. If a medicine is imported from Belgium, for example, this is labelled in French and Flemish. The package leaflet is written in these languages. The applicant must ensure that all the information relating to the medicine can be understood by professionals and patients in Switzerland."

Antibiotics, for example: foreign import

"If the authorised product is no longer being distributed in Switzerland, Swissmedic deletes the authorisation. In the case of medicines for small children, we can ask the manufacturer concerned to make the dossier available free of charge to a Swiss supplier. The manufacturer should also inform doctors and hospitals of therapeutic alternatives. Hospitals and doctors with the corresponding approval then have the option of importing similar products from another country."

Vaccine production capacities

"Currently, worldwide production capacities for many vaccines are not sufficient to satisfy the global demand. It normally takes five years or more to authorise and manufacture a vaccine. Constructing a new production site for vaccines takes even longer. Vaccines are generally produced economically – not least so that they can also be used in countries with restricted access to medicines, for example regions in Africa and Asia. As soon as Swissmedic receives an application for the authorisation of a vaccine, we start the review process. The vaccine is checked for quality, safety and efficacy. If Swissmedic considers that these all apply, the vaccine is authorised in Switzerland."

Supply bottlenecks

"In 2015, the Federal Office for National Economic Supply (FONES) published an ordinance that requires essential and supply-critical active substances and medicines to be notified. This ordinance is part of the National Economic Supply Act, which emerged in the period after the Second World War. This legislation requires manufacturers to notify the FONES of any supply bottlenecks. Together with the obligation to hold stocks of antibiotics, painkillers and vaccines, this helps prevent supply shortfalls. A report issued last year by the FONES stated that around 70 percent of supply disruptions are attributable to problems in the supply chain. Even a transport delay can lead to a supply bottleneck".

Local production

"One objective might be for manufacturers to produce medicines closer to us again – this applies both to Switzerland and across Europe. Swiss manufacturers should be given incentives to produce more active substances, medicines and vaccines locally. This could help stabilise the supply chain. Whether companies are to be offered such incentives is likely to be discussed in the near future by representatives from politics and business."

“I develop every day.”

Mr Pfenninger, what fascinates you about the subject of medicines and therapeutic products?

"I studied science and am a pharmacist. I love to get involved in as many areas as possible."

What does the head of Stakeholder Engagement do?

"I try to bring together a wide variety of partners from the authorities, politics and manufacturing and learn about their specific concerns and worries. At the same time, I have to determine where, and how, Swissmedic can make a contribution. As a result, I feel at home in many areas, am able to put all of my experience to good use, develop every day and am learning all the time."

What major goal do you still have to achieve?

"I want to do my bit to ensure that Swissmedic is viewed as an efficient, independent and competent authority. My major goal is to achieve the many minor goals and merge them to form one big overall picture."

Andreas Pfenninger