Medicines discount agreement
A drug discount agreement is a contractual agreement between individual drug manufacturers and individual German statutory health insurances on the exclusive supply of health insured persons with individual drugs from the manufacturer. These direct supply contracts were made possible by the Contribution Rate Protection Act (BSSichG) that came into force in January 2003. The Medicines Supply Economic Efficiency Act (AVWG), which came into force in May 2006, and the Statutory Health Insurance Competition Enhancement Act extended the possibilities of the health insurance companies from April 1, 2007. At the same time, many statutory health insurers started supplying their insured with pharmaceuticals with the help of the new discount contracts. The goal pursued by the federal government with the two laws and the resulting drug discount agreements is to reduce the costs of drug spending by statutory health insurances. This reduction in expenditure is intended to help lower non-wage labor costs.
Legal basis and hoped for effects
The contribution rate guarantee law (BSSichG), which came into force on January 1, 2003, enabled the statutory health insurance companies in Germany to conclude contracts with one or more pharmaceutical manufacturers . In expectation of a larger sales volume, the manufacturers grant the health insurance companies discounts , which should help to relieve the health insurance budget. The discount agreements could refer to the entire range (no longer possible since 2011) of a manufacturer or to individual active ingredients . Even discount agreements for individual dosage forms of an active ingredient and individual pack sizes are possible. However, the practical implementation and the actual start of this new form of drug supply for those with statutory health insurance only succeeded through the GKV Competition Strengthening Act (GKV-WSG), which mostly came into force on April 1, 2007, and which many statutory health insurance companies immediately took effect applied. It was only with the GKV-WSG that the manufacturers could be guaranteed (as far as possible) exclusive dispensing of their drugs by the health insurance company .
The federal government hoped that the drug discount agreements would lower the ancillary wage costs by reducing the contributions of employees and employers to statutory health insurance. To this end, the CDU / CSU - SPD federal government under Angela Merkel implemented the 2007 health reform, the basis of which had been worked out by Gerhard Schröder's previous government through the parties SPD and Bündnis 90 / Die Grünen . In 2010, the health insurance companies saved 1.3 billion euros through contractual agreements. However, this does not take into account the transaction costs of the health insurance companies or possible savings through structural shifts in the market.
Furthermore, the Federal Ministry of Health (BMG) hoped that “the quality of care could be improved, profitability increased through more transparency, more intense competition and less bureaucracy and, above all, that the options for the insured could be expanded” . At least the drug discount contracts, however, resulted in an at least temporarily reduced quality of supply due to supply bottlenecks at the contract drug manufacturers with a previously low market share. The transparency of the supply decreased significantly, since the contract contents of the discount contracts are only known to the contractual partners. The hoped -for reduction in bureaucracy was reversed for all those involved in the healthcare system (see below, under “Consequences of the drug discount agreements”). The options and decision-making options of the insured persons have not been expanded, at least with regard to drugs, since the health insurance company's contract design now generally determines the manufacturer of the drug that the patient will receive from now on. The doctor who prescribed it remains responsible and liable for the medication received; he is the only one who has the option of specifying a specific manufacturer of the drug; the pharmacy is bound by the discount agreements. The pharmacist may only dispense another drug in justified exceptional cases (e.g. no divisibility of a drug form, acute care in the emergency service). In this case, this must be documented on the prescription.
Not only some institutions involved in the health system, but also political advisors who were involved in the legislative process, are dissatisfied with the effects of the Statutory Health Insurance Competition Enhancement Act and consider the attempt by the federal government to use the GKV-WSG and the AVWG to view drug discount agreements as cost-cutting instruments establish as failed. Meanwhile, there are increasing voices calling for a restriction of discount contracts or their abolition in favor of more practicable supply models. However, major health insurance companies and their umbrella association have announced that they want to keep the discount agreements, as they believe they have contributed to a successful reduction in drug spending.
Consequences of the drug discount agreements
Consequences for health insurance companies
The statutory health insurance companies select one or more contractual partners. You are bound by the requirements of the procurement law for public clients (law against restraints of competition, GWB). They agree with them for an agreed period (preferably two years) which drugs the contract manufacturer will exclusively dispense to the insured persons of the health insurance company. The health insurance companies benefit from discount payments from contract manufacturers.
In 2015, the statutory health insurance companies received rebate payments of around 3.61 billion euros from pharmaceutical companies.
Consequences for patients
substitution
If the doctor does not prohibit the exchange in his prescription of the drug , the patient in the pharmacy will not receive the drug from the manufacturer named on the prescription, but a drug with the same active ingredient, the same dosage , the same pack size , the same indication range and a comparable one Dosage form from one of the manufacturers who have signed a discount agreement with the patient's health insurance company. Some patients, especially those who have taken medicines from one manufacturer for a very long time, find this change difficult. In these cases, the doctor can insist on the dispensing of the usual drug, but must note this on the prescription (exclusion of aut idem ). However, if the doctor refuses to do this, the patient can only receive the medicine they are used to if he pays the full sales price of the medicine. The patient concerned is only partially reimbursed for these costs retrospectively by his health insurance company, so in this case the previous drug is almost always exchanged for that of the discount contract manufacturer.
If the discount medicinal product determined is a previously uncommon preparation from a new contract manufacturer, the delivery of the medicinal product may be delayed. However, thanks to the rapid distribution system of public pharmacies, the drug is in most cases in the patient's hand in less than half a day. Some health insurance companies have concluded discount agreements with practically all major manufacturers, so that there is once again freedom of choice for doctors and pharmacists.
There are also health insurance companies that allow the manufacturer up to four months from the validity of the discount contract before they can deliver the discount drug (peace obligation), so that the pharmacies must prove unavailability during this period in order to be able to dispense another drug.
Co-payment
A drug that is dispensed on the basis of a drug discount agreement is not automatically exempt from the additional payment . It is at the discretion of the health insurance company whether it would like to waive the patient's co-payment in full or in half ( Section 31, Paragraph 3, Sentence 5, SGB V). Some health insurances grant the co-payment exemption to improve patient acceptance of the discounted drugs. The exemption based on the fixed price only applies as long as the drug fulfills this price condition. If the health insurance associations or the Federal Ministry of Health reduce the fixed amount or if the manufacturer increases the sales price, this exemption from the obligation to pay co-payments no longer applies . This can change every two weeks if the price change data has been included in the Lauer-Taxe , the price list for drugs and pharmacy-standard goods.
Consequences for the drug manufacturer
The introduction of discount agreements in the German health system resulted in some massive shifts in market shares among drug manufacturers. This is mainly a consequence of the round of discounts by the Allgemeine Ortskrankenkassen (AOK), in which the large generic manufacturers of 2007 did not participate, and instead smaller pharmaceutical companies took part. In the early days of discount contracts in 2007, some drugs were some manufacturers whose market share in the drug supply had previously been very low, who had then suddenly to supply a large number of insured large health insurance companies almost . When new discount agreements come into effect at the turn of the year, there may still be brief delivery delays until the pharmacies have adjusted their warehouses to the new discount situation. Due to the changed market situation, the medical field service at many manufacturers has been significantly reduced.
Consequences for doctors and pharmacists
Especially in the early days of the discount agreements from April 2007, doctors' practices and pharmacies needed a considerable amount of explanation about the new situation. The implementation of the discount agreements turned out to be difficult because the medication of many patients had to be exchanged to a considerable extent and in a very short time. In particular, the medication of patients suffering from food and additive intolerance requires extensive compatibility testing, as other tablet additives may be contained in the drugs that have been exchanged. The changes in the practice and pharmacy computers and, very rarely, inconsistencies in the discount data records also increased the time required to correctly determine the discount drug.
Even a year later, doctors who do not allow the medication to be exchanged cannot reliably estimate how this will affect their remuneration through the health insurance company. So far, it is unclear whether doctors who prescribe their patients the usual drugs that are not listed in discount contracts will be held liable by the health insurance companies. The pharmacists were often unable to hand over the drugs from the discount agreements, especially in the initial phase of the discount agreements, although they would have to do so in accordance with the regulation. This was due to the fact that supply shortages arose in the case of discount drugs because some large health insurance companies had concluded discount agreements with companies that had barely had a market share in the German health system. However, every single delivery difficulty must be documented, since it cannot be foreseen whether the health insurance company will completely refuse to pay for the drug dispensed if the delivery difficulty cannot be proven. The question of liability also worries doctors, because they are liable if a patient receives a drug that they cannot tolerate and if the doctor has not informed them about this health risk. Since the doctor cannot always predict which medication will be exchanged for, the legal risk for the doctor can be incalculable.
Criticism of the drug discount agreements and legal disruptions
The health insurance companies have been criticized because no figures are published from which the amount of the discount payments made by the manufacturers to the health insurance companies can be determined. The official statistics (KJ1) only show the total amount by type of cash register. The procurement procedure also lacked transparency . As a result, at the end of 2007 some manufacturers sued certain health insurance companies because they were ignored when the contract was awarded. The public procurement tribunal of the Düsseldorf district government , a court that examines contracts for compliance with competition law provisions, then issued a ban on awarding contracts. The procurement chamber of the Federal Cartel Office also stopped the award of contracts by prohibiting awards. The health insurers concerned were therefore prohibited from concluding the discount agreement, while some of them lodged a complaint with a social court.
Curiously enough, various regional courts ruling under competition law and social courts ruling under social law subsequently declared themselves responsible and thus the other type of court was not responsible. The judging courts made completely opposing decisions. This legal confusion is attributed to the inclusion of competition law elements in Book V of the Social Code (SGB V), which revealed a conflict of norms between social legislation followed by statutory health insurers and the legal provisions of the Commercial Code , which drug manufacturers follow as companies. Representatives of the drug manufacturers as well as the statutory health insurance companies called on the legislature to ensure legal clarity.
On April 22nd, 2008, the Federal Social Court decided that in the event of disputes due to the health insurances' mandate to provide care, the only way for your insured persons to go through the social courts (Ref .: B 1 SF 1/08 R). According to the statements of the court, this is in accordance with the Basic Law and the provisions of European law. Nevertheless, there was no legal certainty for the statutory health insurance companies and the pharmaceutical manufacturers because it remained unclear whether the proceedings then ongoing before the regional courts and procurement chambers were to be continued despite this decision by the Federal Social Court. Since the first-named instances insisted on their jurisdiction in accordance with competition law, the Federal Court of Justice (BGH), as the last instance of ordinary jurisdiction, decided on jurisdiction. On July 15, 2008, he pronounced a judgment on a specific case that had previously been decided by the Federal Social Court. The BGH made it clear that the specific judgment was valid because the Federal Social Court, as a supreme federal court, had pronounced a “fundamentally binding” judgment for this procedure, but contradicted the Federal Social Court's opinion that the social courts are generally responsible for legal disputes on drug discount contracts be. The reason given by the Federal Court of Justice was that social court proceedings lasted far too long compared to proceedings in civil courts. The Federal Social Court rejected the criticism of the BGH expressed in the judgment: The duration of the proceedings was not slower on the social court route, the BSG had already made a final decision on the process route in the judgment.
Meanwhile, the European Commission had threatened the German government with infringement proceedings before the European Court of Justice . The discount contracts of the statutory health insurances contradict the EU rules for the award of contracts by the public sector and exclude pharmaceutical manufacturers who could not conclude a discount contract from the German health market. The federal government was given two months to revise the social legislation to meet the demands of the European Commission.
On December 17, 2008, the “Law for the Further Development of Organizational Structures of Statutory Health Insurance” (GKV-OrgWG) came into force. With the GKV-OrgWG, among other things, the disputed problem areas of discount contracts were reorganized. On the one hand, the applicability of the public procurement law to the discount contracts is clarified by the redesign of § 69 SGB V. The EU's infringement proceedings could therefore have been settled by the fulfillment of the requirements on the part of the EU Commission. A decision about the continuation or completion is still pending.
On the other hand, the question of legal recourse for discount contracts is expressly regulated. The GKV-OrgWG represents a compromise solution between the previously mentioned and potentially authoritative legal channels in relation to the determination of the legal process for disputes under competition law in the area of discount contracts. Section 69 (2) SGB V new version makes public procurement law GWB applicable to contracts of statutory health insurance companies. Insofar as the procurement law is applied due to the presence of the requirements of §§ 97 ff. GWB, legal protection according to §§ 102 ff. GWB is also given. Accordingly, a review procedure according to § 104 ff. GWB must first be carried out before the public procurement tribunals . According to Section 116 (1) sentence 1 GWB, immediate complaints can be lodged against decisions of the public procurement tribunals regardless of the subject of the dispute. However, with regard to disputes in the area of legal relationships established in accordance with Section 69 of the Book V of the Social Code, an immediate complaint must be made in accordance with Section 116, Paragraph 3, Clause 1. 2 GWB new version, the regional social courts have jurisdiction. The modalities of such a procedure are regulated in § 142a SGG new version . This essentially refers to the provisions of the immediate complaint according to §§ 116 ff. GWB and should serve an accelerated and appropriate decision. According to the new legal regulation, a special allocation is required in accordance with Section 130a (9) SGB V a. F. no longer possible. In order to avoid persistent uncertainties and the resulting further delays in proceedings that are already pending, these are transferred to the regional courts in accordance with Section 207 SGG new version. With the entry into force of the Act on the Reform of the Market for Medicinal Products (AMNOG), responsibility was transferred again from the regional social courts to the higher regional courts on January 1, 2011.
→ see also: Section "Pharmaceutical Discount Agreements" in the Article Procurement Law
Another point of criticism was that the discount payments were not included in the calculations of the drug expenses, so that there was a distortion of an unknown amount in the information on drug costs. Therefore, from the third quarter of 2008, the health insurance companies are obliged to submit an invoice in which the discounts are shown in detail.
The German Generics Association , which was dissolved at the end of 2012 and represents the interests of small and medium-sized generics suppliers, called in 2008 to end the “experiment on discount contracts”, as “chaos without rules and transparency has arisen”, which is particularly a burden on medium-sized companies carried out on the backs of patients, doctors and pharmacists ”.
Web links
- Federal Ministry of Health : Information on the Drug Supply Efficiency Act - AVWG
- Drug Supply Economy Act - AVWG : Legal text on buzer.de
- National Association of Statutory Health Insurance Physicians (KBV) : Drug information service about discounts
- Medicinal Compass : Medicines database for patients of the statutory health insurance companies
Individual evidence
- ↑ Contribution rate protection law Publication in the Bundesanzeiger Verlag [1]
- ↑ a b c Drug Supply Economy Act - AVWG ( page no longer available , search in web archives ) Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice. - Information offered by the Federal Ministry of Health
- ↑ a b Text and amendments to the GKV Competition Strengthening Act
- ↑ a b Health Reform 2007 ( page no longer available , search in web archives ) Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice. - Information offered by the Federal Ministry of Health
- ↑ a b Management Congress - Nobody likes the GKV-WSG . Pharmaceutical newspaper 46/2007
- ↑ - ( Memento of the original from January 31, 2012 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice.
- ↑ a b German Generics Association demands: End the experiment “discount agreements”! ( Page no longer available , search in web archives ) Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice. Press release of the German Generics Association of March 13, 2008 (PDF, 76 kB)
- ↑ a b Discount agreements - manufacturers see SMEs in danger . Pharmaceutical newspaper 19/2008
- ↑ target prices: In principle, yes, but ... . Pharmaceutical Newspaper - News Archive
- ↑ a b Act to improve profitability in the supply of pharmaceuticals (Drug Supply Economy Act - AVWG) at buzer.de
- ↑ http://www.bmg.bund.de/presse/pressemitteilungen/pressemitteilungen-2016-1-quartal/gkv-finanzverbindungen-2015.html
- ↑ a b [ pharmaceutical expenditure - the pharmacists as problem solvers ]. Pharmaceutical newspaper 06/ 2008
- ^ German Pharmacists' Day 2007 - opening of the Expopharm Pharmazeutische Zeitung, online archive
- ↑ http://www.pharmazeutische-zeitung.de/index.php?id=39169 "The AOK knew when we could deliver"
- ^ AOK discount agreement - Alliance of the Nameless . Pharmaceutical newspaper 07/2007
- ↑ Discount agreement - AOK admits transition problems . Pharmaceutical newspaper 18/2007
- ↑ Discount drugs - substitute health insurance companies start retax orgy . Pharmaceutical newspaper 12/2008:
- ↑ Discount agreements - doctors worry about liability . Pharmaceutical newspaper 33/2007:
- ↑ Health: Pharmaceutical company stops discount negotiations . Spiegel Online - Article from September 27, 2007
- ↑ a b Discount contracts - legislators should fix it . Pharmaceutical newspaper 02/2008
- ↑ Discount agreements - courts disagree over jurisdiction . Pharmaceutical newspaper 48/2007:
- ↑ Press release of the BSG of April 22, 2008 - Procedure No. 7
- ↑ Discount agreements: BSG supports Stuttgarter Richter Pharmazeutische Zeitung - PZ news archive from April 22, 2008
- ^ AOK discount contracts I - BGH ruling does not provide clarity . Pharmaceutical newspaper 34/2008
- ^ AOK discount agreements II - BSG criticizes BGH decision . Pharmaceutical newspaper 34/2008
- ↑ Medication discount contracts - EU threatens Germany with legal action . Handelsblatt, May 6, 2008
- ↑ Law on the further development of organizational structures in statutory health insurance (GKV-OrgWG) , text and amendments ( Federal Law Gazette I p. 2426 , PDF)
- ↑ BT-Drs. 16/10609 pp. 9, 65 (PDF).
- ↑ BT-Drs. 16/10609 pp. 15, 34-36, 74, 81-83 (PDF).
- ↑ BT-Drs. 17/3698 pp. 40–41 (PDF)
- ↑ BT-Drs. 16/9284 p. 7.
- ^ Deutscher Generikaverband - Experiment to terminate discount agreements . Deutsche Apotheker-Zeitung 12/2008: p. 28.
