Health: Drugs: Bundestag decides on anti-bottleneck law

The range of important medicines, especially for children, should be better secured against supply bottlenecks. This is the aim of legislative plans by Federal Minister of Health Karl Lauterbach (SPD), which the Bundestag is to adopt today.

Among other things, there should be specifications for stocks for several months as a safety buffer. In addition, price rules are to be changed to make deliveries to Germany more lucrative for manufacturers. The traffic light coalition also attaches other regulations to the law – for example on sick leave by telephone and drug checks.

A good 490 reports of bottlenecks

The drug plans got under way after a wave of infections in the Advent season, when delivery problems with children’s medicines such as fever and cough syrups escalated. However, there have been general supply risks for some time. Drugs for adults were also affected, such as cancer drugs and antibiotics.

The Federal Institute for Drugs and Medical Devices currently has a good 490 reports of bottlenecks. At the end of April, the Federal Ministry of Health also identified a shortage of antibiotic-containing juices for children, which temporarily allows more flexible reactions.

The law with the abbreviation “ALBVVG”, i.e. the “Drug Supply Bottleneck Combating and Supply Improvement Act”, should now provide basic safeguards. An overview of key points:

safety buffer

For all medicines with discount contracts from the health insurance companies, manufacturers should have to stock up – and one as large as an average delivery quantity for six months. Initially, a three-month buffer was planned. The association of manufacturers of off-patent drugs, Pro Generika, has already warned that there is a lack of production capacity for this. In addition, warehousing causes more costs – and that intensifies the cost pressure as a reason for exits from production.

funds for children

There should no longer be any discount agreements for children’s medicines, with which prices for the health insurers as bulk buyers are pushed down. Manufacturers should also be allowed to raise their sales prices once by up to 50 percent of the last applicable “fixed amount” – i.e. the maximum amount that the statutory health insurance companies have paid for a preparation so far. There should then no longer be any new fixed amounts for children’s medication. In addition, a delivery quantity for four weeks should generally be kept in stock at wholesalers.

pharmacies and cash registers

For pharmacies, an exchange for similar preparations should be easier. With hospital pharmacies, they should also be able to exchange simple medicines with each other in the event of bottlenecks. The Federal Institute for Drugs should get more information from the market and set up an early warning system. European pharmaceutical manufacturers should have more of a say in the tenders of the funds. Overall, the cash registers expect annual additional costs “at least in the high three-digit million range,” as the central association warned. This is offset by the mere expectation of security of supply.

sick leave

After the end of a special corona regulation in April, sick leave by phone should also be possible permanently without visiting the doctor’s office – provided that it is about illnesses without severe symptoms and you are already known to the doctor from previous treatments. This should relieve practices and patients, especially parents with children. The joint federal committee of doctors, health insurers and clinics is to work out the exact regulation.

addiction policy

Offers to examine the ingredients of drugs (“drug checking”) should be possible nationwide. On the other hand, the ban on “substance analysis” by staff in drug consumption rooms in the Narcotics Act should be abolished. The federal states should be able to allow pilot projects “if the analysis is associated with a risk assessment and health education”.

The Greens politician Linda Heitmann said that adults could use drugs “with less risk”. In this way, you can also reach consumers in the club and festival culture, provide information and reduce health risks. “In many federal states, carriers are already in the starting blocks.”

drug advertising

In commercials and advertisements for medicines, the well-known, prescribed warning text is to be changed and in future read: “Read the package leaflet about risks and side effects and ask your doctor or your pharmacy”. According to the draft, this should “take into account aspects of equal opportunities policy”. The end of the sentence “… and ask your doctor or pharmacist” which has been in use for three decades is to be replaced.