Orphan drugs have a special position under EU pharma laws. Among other things, the EU orphan drug laws grant the marketing authorization holder (MAH) of an orphan drug a 10 year period of so-called “market exclusivity”. According to Article 8(1) of the Regulation (EC) No. 141/2000 on orphan medicinal products,
Continue Reading German court strengthens market exclusivity right of orphan drugs and the legal position of their marketing authorization holders
Germany plans significant hospital reform with broad impact on life sciences companies
Germany’s hospital system is reported to be of high quality but is also very expensive by international standards. Hospitals and healthcare payers such as health insurances are exposed to increasing economic constraints. One particular point of criticism is, for example, the current system of Diagnosis Related Group (DRG)-based fees.
Patient treatments are compensated based on the DRGs which effectively leads to a lump-sum payment system per diagnosis (with certain exemptions). This system has pros and cons. As a downside, it is reported to create incentives for over-treatments to generate DRG-based fees per patient.
At the same time, many hospitals in Germany are at risk of closure and insolvency due to financial challenges. The German federal states have thus asked the federal government for financial support to finance the restructuring of the hospital system and prevent hospitals from bankruptcy.Continue Reading Germany plans significant hospital reform with broad impact on life sciences companies
Germany to enact new law with significant changes to drug pricing and reimbursement rules
In an earlier blog, we noted that the German drug pricing and reimbursement laws are among the most complicated legal areas in the entire field of life sciences law. Now, these laws and the respective German market access rules are becoming more complicated. A new law will come into effect in the next few weeks.Continue Reading Germany to enact new law with significant changes to drug pricing and reimbursement rules
Germany plans Health Data Use Act and stricter pricing & reimbursement rules for Digital Health Apps
At the end of June 2023, a draft Health Data Use Act (“GDNG”) and a draft Digital Act (“DigiG”) of the German Federal Ministry of Health have become public. These drafts are part of the German government’s digitalization strategy for the health sector. The Health Data Use Act plans to grant industry companies an access right to patient health data for research purposes. The Digital Act envisages significant restrictions for the pricing and reimbursement of Digital Health Apps. Below, we summarize key aspects of these two legislation proposals.Continue Reading Germany plans Health Data Use Act and stricter pricing & reimbursement rules for Digital Health Apps
German Government presents new law to incentivize paediatric medicines and antibiotics and to combat generics shortages
On 14 February 2023, the German Federal Ministry of Health (BMG) has presented the new draft “Act to Combat Supply Shortages of Off-Patent Medicines and to Improve the Supply of Paediatric Medicines” (Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz or “ALBVVG”). Some commentators also refer to the new law
Continue Reading German Government presents new law to incentivize paediatric medicines and antibiotics and to combat generics shortages
CJEU Rules on the Advertising of “Unspecified Medicinal Products” in the EU
On 22 December 2022, the Court of Justice of the European Union (CJEU) — sitting in Grand Chamber — published its judgement in case C-530, Euroaptieka. The judgement adds further commentary to the meaning of “advertising medicinal products” in the EU and the competencies of EU Member States to restrict drug advertising activities. The judgement has particular implications for advertising “unspecified medicinal products”. No doubt, this judgement will be of interest to pharmaceutical companies and pharmacies looking at the communications activities they carry out in the EU and the risks entailed.Continue Reading CJEU Rules on the Advertising of “Unspecified Medicinal Products” in the EU
European Commission proposes significant changes to transition timelines of the Medical Device Regulation and IVD Regulation
Further to our discussion on the European Commission’s proposal to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the Commission has adopted a formal proposal for a legislative amendment of the MDR and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and published a press release, Q&A and factsheet on the proposal. The proposal does not introduce any substantive changes to the broader MDR but focuses on amending the transitional provisions in the MDR.
The proposed changes to the MDR transition provisions aim to address concerns regarding Notified Body capacity and the significant number of medical devices yet to transition from the former Directives to the MDR. This situation is currently threatening the availability of such devices within the EU market.Continue Reading European Commission proposes significant changes to transition timelines of the Medical Device Regulation and IVD Regulation
Germany significantly tightens Drug Pricing and Reimbursement Laws
The German regulation of pricing and reimbursement of pharmaceuticals is probably one of the most complicated legal areas in the entire world of life sciences laws. Now, the German government is adding another layer of complexity to the existing rules.
On 20 October 2022, the German Parliament has accepted the draft Act for the Financial Stabilization of the German Statutory Health Insurance System („GKV-FinStG“). The new act was subject to month-long controversial discussions within and outside of the Parliament and affected stakeholders. This was due to the fact that the new rules will affect almost all players within the healthcare system, including the health insurers, doctors, hospitals, pharmacies and, especially, the pharmaceutical industry. The new law encompasses significant cost-containment measures as the German healthcare system faces increased costs while, at the same time, the system suffers from a reduced inflow of funds.Continue Reading Germany significantly tightens Drug Pricing and Reimbursement Laws
The New Italian Sunshine Act: What Companies Should Know And How To Get Ready
On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act. The Sunshine Act entered into force on 26 June 2022. However, it will become fully enforceable once the Ministry of Health sets up the Public Register where companies will have to disclose their data and issues the necessary implementing acts. This means that realistically the new transparency system will not be operational before 2023. Nonetheless, it is critical that companies operating in Italy make sure that they are ready when the time comes. Here, we outline some of the key features of the new Sunshine Act and the steps that companies could take in preparation.Continue Reading The New Italian Sunshine Act: What Companies Should Know And How To Get Ready
New German Government plans significant changes with Impact on the Healthcare, Life Sciences and Food Sector
Following the federal election in September 2021, Germany will soon be led by a new three-party coalition, the so-called “traffic light coalition”, composed of the Social Democratic Party (SPD), the Liberal Democrats (FDP) and the Green Party (Die Grünen). This new federal government led by the new chancellor Olaf Scholz from the Social Democrats will replace the Merkel administration and will be in office for four years. On November 24, 2021, the new coalition has presented their coalition agreement with their plans for the next 4 years. The agreement needs to be approved by the respective party committees and it is expected that all three parties will approve it.Continue Reading New German Government plans significant changes with Impact on the Healthcare, Life Sciences and Food Sector