EU framework agreement: Medical industry warns of bottlenecks from June | Switzerland

SWITZERLAND [NEWS SERVICE] ⋅ In the midst of the biggest health crisis of the last hundred years, Switzerland is threatened with supply bottlenecks for medical products, warns the industry. She calls for the federal government to make imports easier.

Peter Walthard

The Federal Council has not yet signed the institutional framework agreement with the EU. If nothing changes by May 26th, Switzerland will face consequences as early as the summer, warn various representatives of the medical industry. Then the Mutual Recognition Agreement (MRA) with the EU will expire. This regulates the trade in medical products. If this is not renewed, for which the EU requires the ratification of the framework agreement, significant disruptions in medical care in the EU internal market with direct effects on patient care in Switzerland and the EU are to be expected, according to an open letter published on Wednesday Federal Councilor Alain Berset.

The senders include the FMCH Surgeons Association, Die Spitler Schweiz, the Zrcher Hospitals Association, the Umbrella Association of Swiss Patient Agencies and the Association of Swiss Pharmaceutical Companies. Your demand: The federal government should unilaterally relax the regulations for imports of medical goods from the EU in order to ensure the supply.

The Swiss market is too small for many providers

The administrative effort and regulatory requirements are to be minimized and the requirements for labeling and product documentation are to be reduced to the bare essentials, the letter says. Particularly against the background of the Covid-19 pandemic, it must be ensured that there are as few supply bottlenecks as possible with medical devices

Industry surveys have shown that because of import barriers, every eighth medical product used may no longer be available after the MRA expires. For many providers, the Swiss market is too small to seek separate approval for their products in Switzerland. As long as the MRA applies, EU approval is sufficient. According to this, the federal government must define the framework conditions with its own Swiss Medical Device Ordinance (MepV).

Only if the framework agreement is reached could the MRA be extended in good time before the end of May. The framework agreement with the EU is domestically, however, more controversial than ever. The Federal Council has State Secretary Livia Leu with renegotiations instructed. On the part of the EU, however, it can be heard that there is no further room for negotiation give.

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