Examined

Innovation at Swissmedic "We can help close a gap."

Swissmedic is investing in the future. Advanced therapy medicinal products (ATMPs) offer a beacon of hope for many patients in Switzerland in relieving and curing previously incurable diseases. Swissmedic is creating an innovation-promoting framework by bundling all the activities to do with this category of medicinal products in a new division. The aim is to give patients the fastest possible access to effective, high-quality and safe ATMPs. Philippe Girard, Head of Licensing at Swissmedic, explains the background.

ATMP category

"Innovative ATMP treatments are attracting considerable attention. Not only from scientists and patients, but also from the business world. Numerous incubators*, start-ups and small and medium-sized companies are launching research and development projects in this area. As a regulator and supervisory authority, we want to promote innovations in the therapeutic products sector. At the start of the year, Swissmedic therefore set up a separate division for ATMPs, because their assessment requires specialist knowledge. We are expanding our existing skills in this area so that we can then offer our support to researchers and companies even in early development phases. Our general objective is to learn about, and be able to assess, these medicinal products and their technologies at an early stage, without waiting until an application for authorisation is submitted. If we learn about a product already in the clinical trials phase or in connection with inspections, it makes the assessment in an authorisation procedure simpler and more efficient." * Incubators are organisations that help entrepreneurs in the process of starting a company.

Inventive spirit

"We note that the field of novel treatments involves an active scene of innovative start-ups and small companies that are unable to make progress with their ideas for, in some cases, pioneering medicines. This is often due to regulatory weaknesses. Licensing and authorisation processes are very demanding . That is how it should be and is designed to protect the health of people and animals. But in future, we would like to increasingly approach the companies at an early stage and enable them to avoid making mistakes that might otherwise cause promising treatments to fail due to lack of data or failure to comply with legal requirements. In doing so, we want to promote the inventive spirit in universities, in companies and wherever innovations arise."

Pioneering role

"We want to create an innovation-promoting framework and consciously take on a new role in which we make it easier for small companies and start-ups also to access our knowledge and experience. The law can delay innovation. Because for many new technologies, the appropriate regulation is still lacking. As an internationally recognised and extensively networked authority, we are familiar with the legal framework. We can actively make an important contribution here by making our knowledge available and showing what requirements need to be fulfilled for a licence to be granted or an application approved. Patients should not have to wait for a law to be passed."

ATMPs Advanced therapy medicinal products: The explanation

ATMPs are complex medicinal products for innovative treatments based on genes (gene therapy products), tissues (tissue-engineered products) or cells (somatic cell therapy products). These can be human or xenogeneic (from a different species, alien) in origin and combined with medical devices. ATMPs are subject both to the Transplantation Act and therapeutic products legislation. They offer new, innovative opportunities for the treatment of diseases, injuries or functional disorders in the human body including, for example, certain cancer treatments or mRNA/ viral vector vaccines against COVID-19 or Ebola. That's why it's particularly important to consider the scientific advances made in this area. At Swissmedic, the new ATMP division created at the beginning of the year is responsible for reviewing the quality, safety and efficacy of ATMPs.

Support

"Today, companies can already receive scientific and regulatory advice from Swissmedic as part of the 'Scientific Advice' procedure. In a pilot project, we plan to bundle these support services together and offer them through what we call the Innovation Office. This Innovation Office is not an actual office, but rather a single point of contact where all the information sources converge. We will be testing this pilot strategy in connection with all issues relating to ATMPs. If it proves successful, we will roll out the Innovation Office across all Swissmedic sectors. It is intended to serve as the central point of contact where our experts answer questions relating, for example, to regulatory aspects, clinical trials, the planning of a production plant or the conditions and documentation required for an authorisation."

Quality assurance

"We are the regulator and act as an arbitrator. Only those who are able to prove that their manufactured product is of impeccable quality, effective and safe can receive the authorisation needed from Swissmedic to place it on the market in Switzerland. We know exactly what critical points we need to look at when we license or approve something. We are a stringent and strict authority, and we make no compromises when it comes to patient safety. This also applies to innovations."

Access

"Word has already spread quickly about our plan to set up our Innovation Office as a point of contact for ATMP issues. We want to try and dismantle the barriers and make it easier to access us as the regulator. At the moment, we are interacting with Examinedother authorities, talking to universities and asking small companies about their needs. We are not competing with pharmaceutical consultants, our role is different: we point out what we ultimately need to receive, we point out the destination. The route to that destination has to be worked out by every company itself or with the support of external consultants."

Interaction

"We are planning a communications offensive. Already this year, we will be actively approaching research groups in universities, incubators and start-ups, as well as other stakeholders. Numerous drivers of innovation are located in the Zurich area and around Lake Geneva in particular.

We go where the ideas are, where innovations arise. We are inviting the relevant contacts to approach us with their concerns and questions so that we can actively support them, always with the aim of making modern medicines, or even pioneering treatments, available to patients in Switzerland as quickly as possible."

Resistance

"Some people have a tendency to worry about new approaches in medicine, for example gene therapy. But when they are ill, they are often grateful and happy to be able to rely on these technologies. We must take these worries seriously and show all potential patients that the processes at Swissmedic ensure that only high-quality, safe and effective therapeutic products are authorised by us. In connection with market surveillance, we also ensure that, once authorised, products are constantly monitored. We include any new findings in our benefit-risk evaluation and adjust any granted authorisations accordingly. This also applies in relation to innovative treatments. A medicinal product, vaccine or treatment only receives approval in Switzerland when we have checked everything: the research, the development and the production. And only when we are convinced that this product is safe, effective and of impeccable quality is it made available to patients in Switzerland."

"Swissmedic is a 'knowledge campus' when it comes to the authorisation and licensing of therapeutic products."

Capacity for innovation

"Even a regulatory authority can be innovative, by offering innovative services. Although the legal framework is always slow to change, when we understand, at an early stage, the technologies that underlie the medicinal products that will be submitted for authorisation in future, we can regulate these appropriately and review them faster. The team in the newly formed ATMP division is made up of scientists with different types of specialist know-how. They will be able to answer new, complex questions – and these will always arise when it comes to ATMPs – based on scientific evidence, by working together as a team from the outset. Starting with the research and development, right through to the authorisation and production. Because before we can grant a licence or authorisation, all the specified criteria must be fulfilled. Swissmedic is a 'knowledge campus' when it comes to the authorisation and licensing of therapeutic products. That the Swiss therapeutic products agency is innovative is illustrated by the fact that patients in Switzerland benefit from fast access to new types of treatment and the latest medicines. Perhaps even increasingly before anywhere else in the world. That is our goal."