Drug supply economic efficiency law

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Basic data
Title: Law to improve
profitability in the supply of pharmaceuticals
Short title: Drug supply economic efficiency law
Abbreviation: AVWG
Type: Federal law
Scope: Federal Republic of Germany
Legal matter: Social law
Issued on: April 26, 2006
( BGBl. I p. 984 )
Entry into force on: May 1, 2006
Please note the note on the applicable legal version.

The Drug Supply Economy Act (AVWG) was passed by the German Bundestag on February 17, 2006 with the votes of the CDU / CSU and SPD . April 1, 2006, originally intended for the law to come into force, could not be adhered to due to the appeal of the mediation committee by the Federal Council . The mediation committee, however, passed the law back to the Bundestag without any changes, which passed it again on April 7, 2006, so that it could come into force on May 1, 2006.

Aim of the law

With the AVWG, the federal government pursued the goal of reducing drug expenditure in the area of statutory health insurance . The target for 2006 was savings of around EUR 1 billion. The VAT increase in 2007 led to a reduction in these targets to around EUR 500 million annually. In the course of the introduction of the AVWG, changes were made to the Fifth Book of the Social Security Code . This particularly affected paragraphs 31, 35 and 71 ff. Further changes were made in the Therapeutic Products Advertising Act .

After the introduction of the AVWG, the growth in pharmaceutical spending decreased. In July, spending was 1.8% below the previous month. By November 2006, spending fell from 10.6 percent in the first quarter of the year to 1.9 percent. By July 2007, the co-payment obligation was no longer applicable for 11,226 preparations.

The most important regulations

From April 1, 2006 to March 31, 2008 there will be a two-year price freeze for drugs that are prescribed at the expense of statutory health insurance companies. The fixed amount limits for the reimbursement of medicines by the statutory health insurance are being redefined. For off- patent drugs with the same ingredients that are offered by several companies ( generics ), a discount of 10 percent of the manufacturer's price is charged. However, the health insurance companies can conclude a special drug discount agreement with the manufacturers . The discount contracts only have a greater effect through the 2007 health reform ( GKV-WSG ): If a doctor does not expressly exclude the exchange, only packs from the discount partners may be handed in. The AOK was the first to make greater use of this new option and concluded discount agreements for 43 active ingredients / active ingredient combinations with several manufacturers, which must be implemented in pharmacies from April 1, 2007. All health insurance companies are now negotiating with drug manufacturers and concluding large-scale discount agreements.

The distribution of free pharmaceutical packs (discounts in kind) by pharmaceutical companies and wholesalers to pharmacies is to be prevented. Practice software that is to be used in medical practices may only be approved by the Association of Statutory Health Insurance Physicians if it allows a manipulation-free price comparison.

The so-called bonus-malus rule applies to doctors . The targets for drug expenditure for certain high-turnover active ingredients and active ingredient groups are determined with the aid of the average costs per defined dosage unit on the basis of defined daily doses ( DDD ). These defined daily doses are set by DIMDI in Germany . If these targets are exceeded by 10 percent, the prescribing doctor has to reimburse the medication costs proportionately. If the drug expenditure falls below the specified amount, the health insurance companies pay a bonus to the associated association of statutory health insurance physicians. When a patient is discharged, hospitals should prescribe drugs that are appropriate and economical even when prescribed in statutory health care.

Medicines with prices of 30 percent and more below the fixed amount can be exempted from co-payment by resolution of the central associations of the health insurance companies . This gives those insured in statutory health insurance the opportunity to receive the most affordable fixed-price drugs without additional payment.

criticism

The introduction of the law led to criticism from pharmaceutical companies, pharmacists, doctors and patient self-help associations.

The associations of pharmaceutical companies anticipate a drop in sales as a result of the law and the associated job losses and a decline in innovative drugs. The North Rhine-Westphalian pharmacists fear that the introduction of the law will result in financial losses for pharmacists, which would lead to a loss of quality in the supply of medicines.

The National Association of Statutory Health Insurance Physicians criticizes in particular the bonus-malus system and the additional administrative costs associated with the law. The bonus-malus system would lead to uncertainty among contract doctors and plunge them into an ethical dilemma. The trusting relationship between doctor and patient could be impaired. According to a study by Refaconsult, the additional bureaucratic costs are estimated at between 494.5 and 531.3 million euros.

The MEDI working group considers the orientation towards daily therapy costs to be wrong, since the DDD is only a guide and should not be confused with a therapeutic or recommended dose.

The Federal Working Group on Self-Help for People with Disabilities and Chronic Illnesses and their relatives fears further stigmatization of expensive patients, especially the disabled and the chronically ill, through the introduction of the bonus-malus rule. The German Multiple Sclerosis Society sees the supply of chronically ill patients with pharmaceuticals as endangered by the increased co-payments due to the lowering of the fixed amounts. She also fears a more restrictive prescribing practice to the detriment of the patient.

The planned changes through this law led to the largest medical demonstration in the history of the Federal Republic on May 19, 2006.

Impact of the law on practice software

Due to a change in the federal contract, from July 1, 2008, the contracted doctor may only use drug databases including the electronic programs (software) required for their application, which guarantee manipulation-free prescription of drugs. These must be certified by the National Association of Statutory Health Insurance Physicians. To this end, the central associations of health insurance companies and the National Association of Statutory Health Insurance Physicians have drawn up a catalog in which the requirements for the drug modules are defined. The implementation of these criteria is the prerequisite for certification. (H028: Catalog of requirements AVWG)

Web links

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  1. ^ "Pharmaceutical expenditure in June slightly declining" Article in the Deutsche Apothekerzeitung on July 30, 2006, accessed on March 9, 2019
  2. ^ ABDA: Members - ABDA - Federal Association of German Pharmacists' Associations January 3, 2007.
  3. ↑ Pharmaceutical compacts: More and more drugs free of additional payments report, GKV portal Krankenkassen.de, accessed on March 9, 2019
  4. ^ See on the new discounting Kai P. Purnhagen, discount granting for pharmacy-only drugs according to the law for the improvement of economic efficiency in the drug supply (AVWG), Medizinrecht 2006, 315-320
  5. ^ Cerstin Gammelin : Patented profit . In: The time . April 6, 2006.
  6. ↑ North Rhine Pharmacists : North Rhine-Westphalian pharmacists warns of an emergency for patients ( memento of February 25, 2014 in the Internet Archive ) January 3, 2007.
  7. ↑ KBV: http://daris.kbv.de/daris/doccontent.dll?LibraryName=EXTDARIS^DMSSLAVE&SystemType=2&LogonId=ee823139482fd06b2a436a4f95b93dfc&DocId=003749779&Page=1  ( page no longer available , searching web archives )  Info: The link is automatically considered defective marked. Please check the link according to the instructions and then remove this notice. (dead link) January 3, 2007.@1@ 2Template: Toter Link / daris.kbv.de  
  8. ↑ Refaconsult: http://www.refaconsult.de/uploads/media/Bonus-Malus-Regelung.pdf (dead link) January 3, 2007.
  9. ↑ Ute Burtke: AVWG: Nonstop nonsense when prescribing ( Memento from September 28, 2007 in the Internet Archive ) In: Ärztliche Praxis . May 9, 2006.
  10. ^ BAG self-help: archive link ( Memento from May 23, 2006 in the Internet Archive ) (dead link) June 17, 2006.
  11. ↑ DMSG: Savings Act: more efficient care for patients? Medical advisory board takes a critical position ( memento from January 6, 2007 in the Internet Archive ) January 3, 2007.