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In Environment

South Africa: The latest developments in Just Energy Transition

by 7 Mins Read

At COP 27 in November 2022, South Africa launched its new Just Energy Transition Investment Plan and announced a five-year investment plan for the USD 8.5 billion financing package, which was announced as part of the country’s Just Energy Transition Partnership with France, Germany, the United Kingdom, the United States and the European Union at COP 26. The JET IP is aligned with the Cabinet-approved National Just Transition Framework and outlines the investments required to achieve the country’s decarbonization commitments, while promoting sustainable development, and ensuring a just transition for affected workers and communities.

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In ESG

Germany: New German Supply Chain Due Diligence Act — The early bird catches the worm

by and 6 Mins Read

After the introduction of the UK Modern Slavery Act, the French Duty of Vigilance Law, Germany also followed by adopting the Act on Corporate Due Diligence Obligations in Supply Chains (Lieferkettensorgfaltspflichtengesetz or “LkSG”). The LkSG lays down extensive obligations for companies with regard to their own business area, but also their direct and indirect suppliers. Many of the necessary measures require preparation. Therefore, companies should finalize their preparation in the coming weeks as the LkSG enters into force in 2023.

In Product Regulation & Liability

Germany: ‘Legalize it?!’ Latest developments of plans on the legalization of cannabis for recreational use

by , and 4 Mins Read

Roughly one year after the federal election in September 2021, the German government’s plans to legalize cannabis for recreational use have further taken shape. German Minister of Health Karl Lauterbach has introduced a document on the key points of the planned legislative changes on Wednesday, 26 October 2022. According to this document, cultivation, distribution and taxation — as well as advertisement for recreational use — of cannabis will be specifically regulated.

In

Germany: The Hamamatsu TP/customs valuation case comes to a surprising conclusion

by and 4 Mins Read

On 17 May 2022 the German Federal Fiscal Court – which is the Highest court for tax related matters in Germany – gave its final judgement in the (in)famous Hamamatsu case. This proceeding is part of the referral to the European Court of Justice that resulted in a startling – albeit unclear – decision by the ECJ that retroactive TP-adjustments (whether upwards or downwards) are not to be considered in the determination of the customs value.

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In Tax

Germany: Reform of tax audit rules underway

by and 3 Mins Read

On 12 July 2022, the German Ministry of Finance has published a preliminary draft ministerial bill that, inter alia, provides for a reform of the tax audit and bookkeeping rules in the German General Tax Code and the German Act on crossborder administrative cooperation within the EU for tax audits. The draft has been resolved by the Federal Cabinett on 24 August 2022 and on 29 August 2022 the official Government’s Draft Bill has been published.

In Product Regulation and Liability

Germany: New reimbursement price for German medical cannabis flowers

by , and 6 Mins Read

EUR 4.30 instead of EUR 9.52 per gram: The reimbursable base price for medical cannabis cultivated in Germany has been almost cut in half whereas the base price for imported cannabis flowers remains unaffected. According to an arbitration ruling of 17 June 2022, a base price of EUR 4.30 (plus surcharges of 90% or 100%) per gram is reimbursable for cannabis flowers cultivated in Germany. Prior to the ruling, statutory health insurance funds reimbursed a base price of EUR 9.52 per gram plus varying surcharges for all cannabis flowers. This also applied to cannabis flowers cultivated in Germany and sold to pharmacies for a fixed price of only EUR 4.30 per gram.

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In Antitrust / Competition

Germany/Europe: Current Developments in German and European Antitrust Law

by , , , , , , , , , , , , and 1 Min Read

On 21 September 2022, colleagues from the German Baker McKenzie offices will host a webinar exploring current developments in German and European Antitrust Law. The event will be in German only.

In Whistleblowing

Germany: The government draft of the Whistleblower Protection Act

by , and 7 Mins Read

The EU Whistleblower Directive has been in force since 16 December 2019, and was to be implemented in national law by 17 December 2021. On 27 July 2022, the German Federal Cabinet approved a government draft of the Whistleblower Protection Act, so that — with considerable delay — the further legislative process has been initiated.

In Product Regulation & Liability

Germany: German government announces bill to drastically slash drug reimbursement

by , and 7 Mins Read

On 8 July 2022, the German Health Ministry officially shared the second edition of a new bill referred to as the Act for Financial Stability of the Public Health Insurance (GKV-Finanzstabilisierungsgesetz). The bill is still subject to discussions with stakeholders and several rounds of congress hearings. If ultimately implemented, which is a likely scenario, pharma companies will face several painful cutbacks on the statutory reimbursement of prescription-only medicinal products.

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