Regulatory and pricing systems
Regulation
Switzerland's regulatory agency is called Swissmedic and is based in Bern. Although Swissmedic is linked to Switzerland's
Federal Department of Home Affairs, it is independent and has its own budget and, as with many other regulatory agencies,
it is funded from the fees it charges for regulatory applications and payments from the government for public services.
The agency cooperates closely with foreign agencies, including the EMA. Indeed, the EMA has had a mutual recognition agreement
in place with Switzerland since 2002 (12). In principle, the agreement is to avoid duplication of procedures when Swiss and
EMA requirements are deemed equivalent, but the nature of acceptable processes is frequently updated. In 2010, the EMA and
Swissmedic updated their agreement regarding GMP inspection and batch certification to account for advanced therapy medicinal
products, such as those in the field of transplants. This update was made because new regulations on advanced therapy medicinal
products had separately come into force in the EU and Switzerland since 2007, but had not been considered in the context of
the original mutual recognition agreement (12). The 2010 discussions between the agencies were designed to close any loopholes
and avoid potential, regulatory misunderstandings regarding these types of products. The original agreements state the equivalence
of the two GMP systems, so that a manufacturer in the EU or in Switzerland can release a batch of medicinal product for sale
or supply into the market of either party. Although the agreement does relax some of the requirements for operating in the
other market, manufacturers must still have an effective batch-recall system to ensure that products can be recalled at any
time when so required (12).
Another example of the two agencies cooperating on an area of mutual interest was during the 2009 H1N1 influenza pandemic.
This collaboration was renewed in February 2011, with the two agencies agreeing to share confidential information about the
authorisation and safety of medicines used in the context of H1N1 pandemic influenza.
Pricing
Swissmedic's work covers registration and approvals, but it is the Swiss federal government that decides on the maximal allowable
public price for drugs in the country. This price is calculated from the ex-factory manufacturer price, distribution costs
and a valueadded tax rate of 2.5% (2). The Federal Office of Public Health (FOPH) is the final decision-making body for pricing
and reimbursement of approved drugs. The FOPH bases its decisions on product cost-effectiveness and also benchmarks prices
with those in Germany, the UK, Denmark, the Netherlands, France and Austria. If the FOPH gives a positive reimbursement decision,
then a drug is listed in a positive drug list called the Spezialitätenliste within 30 days. The pricing and reimbursement
status of drugs is reviewed every three years and after patent expiry, but drugs that are considered particularly innovative
can receive a discretionary additional 20% price reward (2). From 2012, generics can also be included in the Spezialitätenliste,
if their ex-factory price is 10–60% lower than the Swiss reference product after patent expiry.
Summary
Being one of the EU's major trade partners, Switzerland is a huge force in the European pharmaceutical market. In 2010, 41.5%
of EU pharmaceutical imports came from Switzerland (3), which means that the performance of the Swiss pharmaceutical industry
has a strong bearing on what happens to the pharmaceutical sector in the rest of Europe.
References
1. Swissinfo, "Cheaper Prices Slow Down Pharma Market Growth" (Switzerland),
http://www.swissinfo.ch/, accessed 8 June 2011.
2. International Society for Pharmacoeconomics and Outcomes Research (ISPOR), "Switzerland–Pharmaceutical" (NJ, USA),
http://www.ispor.org/, accessed 8 June 2011.
3. EFPIA, "The Pharmaceutical Industry in Figures" (Belgium),
http://www.efpia.org/, accessed 8 June 2011.
4. SGCI Chemie Pharma Schweiz, "Die schweizerische chemisch-pharmazeutische Industrie" (Switzerland),
http://www.sgci.ch/, accessed 8 June 2011.
5. SIA
http://workpermit.com/, "Switzerland Relaxes Immigration Laws for Most European Nations" (Location of publishing source, 2007),
http://www.workpermit.com/, accessed 8 June 2011.
6. Espicom, "The Pharmaceutical Market: Switzerland" (Chichester, UK, March 2011).
7. Novartis, "Novartis en Suisse" (Switzerland),
http://www.novartis.ch/, accessed 8 June 2011.
8. Roche, "Our Company" (Switzerland),
http://www.roche.ch/, accessed 8 June 2011
9. G. Roth, "2010 Top 20 Pharmaceutical Companies Report," Contract Pharma, online,
http://www.contractpharma.com/contents/view/33747 (9 July 2010), accessed 8 June 2011.
10. A. Langley, "Novartis's Stake in Roche Fuels Merger Speculation," New York Times online,
http://www.nytimes.com/ (23 June 2003), accessed 8 June 2011.
11. "Roche Changes Raise Novartis Takeover Question," Inpharm online,
http://www.inpharm.com/ (29 March 2011) accessed 8 June 2011.
12. EMA, "Switzerland. European Medicines Agency" (UK), accessed 8 June 2011).
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