Market development

Generics are cost-effective treatment alternatives to medicines with the same active substances whose patent protection has expired. The quality testing and the manufacturing of the generic substance is according to the same strict specifications as the original product. To be included on the specialities list at all, generics must be approved as a preparation with a known active substance and the bioequivalence with the original or reference product must be tested and confirmed verifiably. Furthermore, as generics contain the same quantity, concentration and administration form of the active substance as the original medicine, they are in principle equally effective and are usually interchangeable without any problems.

In the year 2016, 971 million francs of generics covered by health insurance were sold in Switzerland, 4.7 percent more than a year before. In the same time period, the consumption increased to 1.347 million daily doses, which represents an increase of 4.2 percent. The market for generics has therefore developed more dynamically than the reimbursement market overall for all medicines covered by health insurance. With market shares of 19 percent in terms of value and 33 percent in terms of volume, generics have caught up nationally, but have not reached the significance achieved in many other European countries.

Generics now exist for 274 active substances or fixed substance combinations, whereby the strong concentration on few suppliers is especially noticeable. Two companies constitute around 73 percent of the turnover and in many indications with primarily small prescription volumes, the number of suppliers is restricted to one or two approval holders. This circumstance is also reflected by the traditionally high market entry barriers, especially the special legal requirements, the strong fragmentation of therapeutic demand and the specific regional circumstances.

In the past, the funders profited especially from the patent expiry for substances with a strong turnover. The direct savings from the generic substitution reached a new peak last year with 363 million francs. The efficiency gains could have been even higher if generics had been prescribed consistently instead of the more expensive original medicines. Owing to the thus saved resources, a “headroom for innovation” can be activated that helps to guarantee quick access to new, innovative and usually cost-intensive treatments. Great savings potential is also attributed to the future biosimilars, such as those of Etanercept and Adalimumab for treating rheumatic disorders and psoriasis, or the monoclonal antibody Rituximab and Trastuzumab, or the haematopoietic growth factor Pegfilgrastim in the field of oncology.

On average, in the year 2016 the treatment costs for generics were 72 centimes per daily dose at reimbursement prices.

«Not only doctors and pharmacists have the duty to use generics for treatment whenever possible – patients should also play their part and speak up.»

Observer

Generics figures in 2016

Savings of millions of francs through generics

Millions of francs worth of generics covered by health insurances sold

Billions of francs of savings in total (direct and indirect)

Market approval

A generic medicine must first be tested at the Swiss Agency for Therapeutic Products Swissmedic. Swissmedic issues the registration (market approval) if the scientific and medical requirements are fulfilled. As a second step, an application is submitted for health insurance coverage. The health insurance coverage is confirmed by the Federal Office of Public Health (BAG) if the generic product is up to 60 % lower priced than the original preparation, depending on the market size. In the case of niche products, which means for originals an annual turnover of 4 million CHF or less, the required price gap is 10 %.

Substitution

According to the legal basis of the Federal Health Insurance Law (KVG) Art. 52a Substitution Law, pharmacists may replace the original products of the specialities list with the cheaper generics on this list, if the doctor or the chiropractor does not explicitly request the administering of the original product. The condition is the agreement of the patient and the information from the prescribing specialist.