Allgemeine Ortskrankenkasse-Bundesverband
AOK-BV
Vertretung der Interessen der elf regionalen AOK Krankenkassen (Allgemeine Ortskrankenkassen); Beratung der EU-Institutionen in allen Fragen, die im Zusammenhang mit der Aufgabenwahrnehmung der gesetzlichen Kranken- und Pflegekassen stehen.
ID: 775903212549-24
Lobbying Activity
Response to EU cardiovascular health plan
15 Sept 2025
As statutory health insurance funds, the AOKs insure around 27.5 million people in Germany and provided services worth 115 billion euros for their insured persons in 2024. With their extensive commitment to prevention and health promotion, the AOKs pursue the goal of preventing diseases from developing in the first place or at least mitigating their progression. Their services are aimed at establishing low-threshold measures to promote a healthy lifestyle and, on the other hand, at establishing health-promoting living environments, starting with daycare centers and schools, through workplace health promotion, to nursing homes. The AOKs welcome the EU's plan to support Member States in reducing the number of people falling ill with cardiovascular diseases and preventing premature deaths for those with existing illnesses or risk factors, such as obesity, high blood pressure, or related comorbidities that increase the risk of developing heart disease. In addition to the best possible treatment of risk factors such as high blood pressure or diabetes mellitus, a significant proportion of cardiovascular diseases could be prevented by addressing risk factors such as tobacco consumption, unhealthy diet, lack of exercise, stress and alcohol consumption. In Germany, around 4 out of 10 deaths can be attributed to the aforementioned risk factors. The burden of disease causes millions of cases of preventable individual suffering and places a financial burden worth billions on social security systems and the economy. A comprehensive strategy for promoting healthy living conditions is needed to improve the health of the population. A rational and evidence-based "cardiovascular strategy" should tackle the problem at its root and combat the causes of cardiovascular disease. Currently, the increasing and preventable disease burden in Germany is increasingly being addressed by a constant expansion of treatment via secondary and tertiary prevention of coronary heart disease. This is too one-sided a focus. People are allowed to become ill first, and then helped to slow down the progression of the disease. This is not a sustainable strategy and, contrary to relevant scientific findings, narrows prevention to early detection medicine. Instead of focusing on early detection and treatment of individual diseases, more attention should be given to the potential of preventive measures to enable healthy growing up and ageing. The greatest leverage lies in the framework conditions for maintaining health and thus outside the healthcare system. Key areas of action include nutrition policy, addiction policy and the promotion of physical activity and active mobility in everyday life - for example, through strategies to promote cycling and walking. The goal should be to make healthy behaviour the easier choice by creating favourable conditions, for example through the EU-wide introduction of the Nutri-Score system or improved regulations to protect children from tobacco, alcohol and nicotine products such as e-cigarettes. Health promotion and prevention can be used to counteract the effects of social inequality on health in the long term and effectively. Healthy living conditions benefit everyone, regardless of socioeconomic status. This requires a strategy geared towards health-promoting conditions and an action plan that embeds health in all policy areas (Health in all policies) in a regulatory framework. This should systematically take into account research and regulatory needs, specific action requirements and campaign feasibility.
Read full responseResponse to Critical Medicines Act
30 Jun 2025
As statutory health insurance funds, the AOKs insure around 27.5 million people in Germany and provided services worth 115 billion euros in 2024. The draft Regulation aims to strengthen the security of supply and availability of critical medicines. Specific measures envisaged are: Expanding production capacities in Europe by identifying strategic projects that address weaknesses in the supply chain and are to benefit from incentives and facilitations; Guidelines for award criteria and conditions that promote the diversification and resilience of supply chains; Strengthening joint procurement by Member States, supported or carried out on behalf of the EU Commission upon request; International partnerships to expand and diversify supply chains in order to reduce dependence on third countries. The draft Regulation focuses on financial incentives and regulatory support for industry without, however, requiring binding and clear conditions for timely and demand-based supply volumes from pharmaceutical companies. There is no guarantee that these subsidized EU production sites and volumes will be utilized to any significant degree by pharmaceutical companies operating in Europe and thus benefitting European patients. This obvious regulatory gap must be closed urgently and accompanied by sanction-based measures. In addition, there is a lack of an EU-wide monitoring and early warning system for the effective management of temporary or longer-term shortages and sanction-based reporting obligations for stocks at all stages of the supply chain, and an effective stockpiling. The actual supply capacity of pharmaceutical companies must be objectively verified and made transparent, for example in a publicly accessible EU deliverability register. Changes to the conditions for awarding public contracts, e. g. in the case of discount contracts for medicines, cannot ensure the establishment or expansion of production sites in the EU. Strengthening EU production and utilization of EU products can be achieved independently from national procurement procedures, for example by binding requirements in EU drug approval through mandatory use and utilization of existing, accredited EU production facilities and pharmaceutical ingredients from EU production. When awarding contracts, public contracting authorities can only rely on objective, independent, and directly accessible information. Immediate access to information on the origin and quantities of the pharmaceutical ingredients used in a medicinal product is necessary. In addition, there must be a transparency obligation for subsidized EU production facilities that are actually used by pharmaceutical companies. The draft Regulation creates, for the first time, a legal basis for giving preference to EU production or production equivalent to EU production in public procurement. However, the regulatory concept is dominated by many vague legal terms. Therefore, the application of further procurement requirements must remain at the discretion of public contracting authorities. If bidders with production facilities in the EU are to be given preference over bidders with production facilities in third countries, and if further procurement criteria are to be applied in addition to price, clear and unambiguous rules of application are necessary to minimize the legal risk for public contracting authorities during implementation. Due to the lack of an impact assessment, it is difficult to estimate whether the Regulation in its current form is at all suitable for achieving the overarching objective of greater security of supply and better market availability of medicinal products.
Read full responseResponse to Evaluation of the Public Procurement Directives
7 Mar 2025
Die AOKs versichern als gesetzliche Krankenkassen in Deutschland rund 27,5 Millionen Menschen und erbrachten im Jahr 2024 Leistungen im Wert von 114,8 Milliarden Euro. Um den Herausforderungen eines sich dynamisch verändernden Beschaffungsumfeldes in öffentlichen Auftragsvergaben erfolgreich zu begegnen, regen die AOKs an, die Richtlinie 2014/24/EU (nachfolgend RL) wie folgt zu überarbeiten: 1) Die Versorgungssicherheit ist durch zusätzliche vergaberechtskonforme Instrumente zu stärken, insbesondere durch Vorgaben für Produktions- und Lagerstätten oder durch qualifizierte Nachweispflichten der Lieferfähigkeit auf Bieterseite. Die RL soll zur strategischen Autonomie beitragen und ausdrücklich ermöglichen, dass Unternehmen aus Nicht-EU-Ländern, insbesondere auch in Nachunternehmerkonstellationen, ausgeschlossen werden können (Umsetzung Urteil EuGH v. 22.10.2024, C-652/22 Rs. Kolin). Es fehlt an Rechtssicherheit für die Berücksichtigung von Zuschlagskriterien zur Bevorzugung von Angeboten, die Produktionsstätten für Arzneimittel in der EU umfassen, und für Möglichkeiten, um Lieferketten zu verkürzen/resilienter zu gestalten und zu fördern. Ungeachtet der Art der zu vergebenden Leistungen, soll den Mitgliedstaaten im Rahmen ihrer gem. Art. 168 Abs. 7 AEUV zugewiesenen Verantwortung für die Organisation des Gesundheitswesens und die medizinische Versorgung ermöglicht werden, den Vergabeprozess autonom zu regeln. 2) Der Prozess des wettbewerblichen Verfahrens bis zur Vorlage vergleichbarer Angebote muss jedenfalls effizienter und zielorientierter gestaltet werden können. Dabei muss geprüft werden, ob die Verrechtlichung der Beschaffung durch die ausdifferenzierte Reglementierung der öffentlichen Auftragsvergabe in der aktuellen RL in Verbindung mit den weitreichenden Individualrechtsschutzmöglichkeiten noch das geeignete Mittel darstellt, um die RL-Ziele unter Aufrechterhaltung der Funktionsfähigkeit der Verwaltung zu erreichen. Denkbar ist daher eine Deregulierung des Vergabeprozesses, so dass sich die RL vorrangig auf die Definition zwingender Vergabegrundsätze und Zielsetzungen sowie die der Transparenz dienlichen Bekanntmachungs- und Informationspflichten fokussiert. Die konkrete Verfahrensausgestaltung mittels ausdifferenzierter Verfahrensarten und -methoden zur Generierung von vergleichbaren Angeboten muss dem Auftraggeber zur freien Bestimmung überlassen werden. Die Rechtsschutzmöglichkeiten sind ebenfalls zu überprüfen, insbesondere das mit dem Primärrechtschutz einhergehende Zuschlagsverbot. Sollte es hingegen bei der aktuellen Regelungslage bleiben, sind zumindest folgende Anpassungen überlegenswert: a. Die Grundsätze und Kriterien der Auftragsvergabe müssen um die Interessen der öffentlichen Hand an effizienter und versorgungsgesicherter Bedarfsdeckung ergänzt werden. Verfahrensbehindernde Rechtsschutzmöglichkeiten dürfen sich nur auf schwerwiegende Rechtsverstöße beschränken. b. Die Schwellenwerte für Liefer- und Dienstleistungsaufträge müssen angesichts der wirtschaftlichen Entwicklungen deutlich angehoben werden. c. Die öffentlich-öffentliche Zusammenarbeit muss auch ohne Vorliegen der In-House-Voraussetzungen oder einer Kooperation durch eine weitere Ausnahme vom Vergaberecht möglich sein, wenn keine privaten Dritten (auch nicht mittelbar als Nachunternehmer) begünstigt werden, d. h. entgeltliche Aufträge über Leistungen vergeben werden, die die öffentliche Hand zu 100% mit eigenen Mitteln und ohne Gewinnabsicht (z.B. auf Selbstkostenerstattungsbasis) erfüllt. d. Es müssen Möglichkeiten geschaffen werden, vorhandene Vergabeverfahrensarten optimaler im Ablauf zu gestalten, z. B. Verhandlungsverfahren mit integriertem Teilnahmewettbewerb, Zulassungs-/Poolverfahren mit anschließendem Wettbewerb um Einzelaufträge als Alternative zu dynamischen Beschaffungssystemen oder Mehrpartnerrahmenvereinbarungen. Es muss kürzere Teilnahmeantragsfristen geben.
Read full responseResponse to Critical Medicines Act
27 Feb 2025
AOK statutory health insurance funds insure about 27.5 million people in Germany providing benefits worth 107 billion Euros in 2023. The AOK welcomes recent efforts to tackle shortages of medicinal products and secure patient care in the EU following a coordinated approach. We express concerns about the absence of a comprehensive impact assessment in the course of CMA, as the impacts on economic sustainability of health care systems are disregarded. To design and implement efficient measures to guarantee continuous and sufficient supply volumes a thorough analysis of root causes and supply chain vulnerabilities is paramount. Possible regulatory and financial incentives must be adequate and require legally binding commitments from the pharmaceutical industry to meet the identified supply needs. Conditions for any incentives should include compliance with the obligations set out in the EU general pharmaceutical legislation in terms of reporting of potential stock disruptions and developing plans to prevent shortages. Manufacturers of critical medicines who received incentives for production should also commit to maintaining adequate stocks including for health crises, prioritizing supply to the European market and/or developing appropriate production capacity to address potential surges in demand. Penalties should be imposed on companies that fail to fulfil these obligations. Responsibility for continuous EU-wide monitoring of supply and shortages should lie with the European Commission, in cooperation with EMA, Member States and relevant healthcare stakeholders. A coordinated reporting system shared by national competent authorities would enhance transparency regarding current and future stocks and shortages. EU strategic reserves of critical medicines and/or active pharmaceutical ingredients should be considered, without prejudice to national stockpiling obligations. As part of the CMA, the stockpiling of active pharmaceutical ingredients as an EU strategic reserve needs to be examined. To facilitate this, stocks must be recorded at all distribution levels digitally and in real time. In addition, the voluntary EU solidarity mechanism for medicines could be used to redistribute existing stocks that exceed national supply needs. Development of international packaging layouts and QR-code related medicine information would provide additional support. Contingency stocks can enable countries to withstand a period of limited supply volumes. Contingency stocks should be located at national level with pharmaceutical companies to avoid expiry date issues by maintaining a rolling stock. The procurement and reimbursement of medicinal products fall within the jurisdiction of the Member States. European procurement law allows for qualitative (MEAT) criteria to be included alongside price. It should be made clear that aspects such as security of supply, production location and the resilience of the supply chain can also be taken into account. Procurement law must continue to ensure the efficient use of social security contributions. While tenders issued by statutory health insurance funds in Germany only aim at reducing prices, not at procuring medicines, many Member States procure medicines for clinical care by means of tenders directly or alternatively via framework contracts and call-off quotas. In this respect, the consequences of the non-conclusion of such contracts are extremely varied. The AOK calls to ensure that the design of public tenders should be defined by tendering authorities only: Which specific MEAT criterion can be applied depends on national legal frameworks. MEAT criteria can conflict with or be equivalent to existing national regulations. Multi-winner tenders cannot contribute to the diversification of supply chains if all bidders depend on a single source. Knowing that this scenario is especially common for critical medicines with vulnerable supply chains, we expect no relevant effects where we need them most urgently.
Read full response11 Dec 2022
The member statutory health insurance funds of the AOK-Bundesverband (Federal Association of the AOK) welcome the European Commission's initiative to modernise product liability law. Particularly due to digitalisation, products and technologies have developed rapidly in recent decades. Modern product liability law must keep pace with this so that no gaps in liability arise. In addition, injured consumers should also be able to enforce justified claims and not fail due to excessively high evidence requirements. The proposal for a new Directive on liability for defective products grants natural persons the right to compensation for damages resulting from defective products, including digital products, software or AI systems. With regard to the right to compensation, for reasons of legal certainty it should be additionally clarified in Article 5(2) and Article 8(1) that the injured parties can be both natural persons and legal entities. In many Member States of the European Union and also in Germany, claims for damages of injured parties are transferred to the health insurance fund by way of cession of right (§ 116 SGB X), insofar as the statutory health insurance fund has to provide benefits on the basis of the statutory insurance coverage. Therefore, the health insurance funds should also be given the right to assert these claims for damages under the same conditions. So far, the standard of proof for the product defect, the damage suffered as well as the causality, which the injured parties have to provide, is determined by laws or jurisprudence of the Member States. The proposal for a Directive reduces the high standard of proof for Member States such as Germany (§ 286 Code of Civil Procedure - ZPO). This is a prerequisite for those injured by defective medicinal products or medical devices to have any chance at all of successfully asserting their justified claims for damages. This also applies equally to injured consumers as well as to their subsequently also injured statutory health insurance funds. In addition to easing the burden of proof, the new right of injured parties to disclosure of manufacturer information strengthens the consumers who have suffered damage in order to counteract the existing asymmetry of information. Particularly in complex cases, the competent national courts have to ensure that there is more equality between manufacturers and injured parties. In doing so, they have to pay attention to a fair balance between the legitimate interests of industry and consumers. Any national liability limits and the property-damage threshold of 500 euros provided for in Article 9 of the currently still valid Product Liability Directive 85/374/EEC are to be removed. In Germany, for example, the current maximum liability limits for damage caused by medicinal products under § 88 of the German Medicines Act (AMG), or by (medical) products under § 10 of the German Product Liability Act (ProdHaftG) and the above-mentioned deductible for damage to property (§ 11 ProdHaftG) would no longer apply. The AOK-Bundesverband shares the European Commission's assessment that the envisaged reduction of restrictions on the assertion of claims and the easing of the burden of proof, particularly in the case of complex products, will have a positive impact on product safety and thus on consumer protection.
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