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INNOVATIVE CAR-T THERAPY REFUNDED IN POLAND FROM MAY 1, 2022 FOR ADULT PATIENTS WITH LYMPHOMA

From May 1, 2022 in Poland adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two lines of systemic treatment will receive funding for the novel CAR-T (tisagenlecleucel) therapy.

CAR-T is a breakthrough in the treatment of hematology patients. The mechanism of action of this therapy is completely different from the drugs used so far. Individualized CAR-T therapy uses the patient’s immune system. The patient’s T lymphocytes are collected and modified outside the body, thanks to which they are able to recognize cancer cells expressing a specific antigen and fight them.

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Inspections launched by the Polish Data Protection Authority

Polish data protection authority announced the launch of inspections regarding compliance with regulations concerning data protection officers and published questions to be asked by the Polish authority in the course of such inspections.

From the beginning of the application of the provisions of the GDPR, the Polish Office for Personal Data Protection, both as part of the ongoing proceedings and in response to reported cases of non-compliance with the provisions on data protection officers, took actions resulting from its powers, specified in art. 58 of GDPR. The previous experience of the supervisory authority in this area has been used to formulate a list of issues which – together with the presentation of relevant evidence – will have to be addressed by the requested controllers and processors.

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PROPOSALS FOR AMENDMENTS TO THE DRAFT REGULATION ON INFORMATION ACCOMPANYING TRANSFERS OF FUNDS AND CERTAIN CRYPTO-ASSETS (RECAST)  — WHAT IT CAN MEAN FOR CRYPTO ASSETS INDUSTRY

On 1 April 2022, the European Parliament’s Committee on Economic and Monetary Affairs (ECON) published a report setting out its proposed amendments to the draft regulation on information accompanying transfers of funds and certain crypto-assets (recast).

The draft report puts forward the following key proposals:

1. No exemptions based on the value of the transfer:

With respect to wire transfers, the Transfer of Funds Regulation requires a payment service provider to ensure that transfers of funds are accompanied by complete information on the originator and the beneficiary and to verify the information on their customer only if the transfers of funds exceeds EUR 1000, individually or as part of small linked transfers which together would exceed EUR 1000, except where the funds to be transferred are received in cash or anonymous electronic money or there are reasonable grounds for suspecting money laundering or terrorist financing. Due to the specific characteristics and risk profile of crypto-assets, the information obligation should apply to crypto-assets transfers, regardless of the value of the transfer. There are clear indications that crypto-asset activities associated with criminal activities and terrorism financing are often transfers of small value. Furthermore, crypto-assets and related technologies enable criminals to split high value transfers into small amounts across multiple wallet addresses in order to avoid detection of AML/CFT monitoring systems and to carry out illicit activities via structured transactions to a scale and global reach not available to wire transfers. In the view of the co-rapporteurs, the removal of a de minimis threshold for crypto-asset transfers would facilitate, rather than complicate, compliance and risk management by cryptoasset service providers. This is particularly relevant in light of the difficulty to identify linked transfers executed via multiple apparently unrelated wallet addresses as well as the high volatility of the valuation of most crypto-assets.

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Generic drugs in Poland

What are generic drugs?

Patent protection for a newly introduced drug on the market lasts almost 20 years. During this time, no other company (except the one with the patent) has the right to produce it. When protection ends, the drug may be manufactured by other manufacturers who begin to compete with each other – such competing drugs are called generics.

The original and generic medicine may differ in name, manufacturer and price. However, the active substance contained in them, which is responsible for the action of the drug, and its amount will always be the same. Thanks to the guarantee of equally high production standards and constant monitoring of safety and effectiveness, patients can freely choose the product that best suits them in the pharmacy. The manufacturing process of generic drugs must follow the principles of Good Manufacturing Practice (GMP). Compliance with the GMP rules allows for the provision of good quality medical devices.

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KIELTYKA GLADKOWSKI RANKED IN THE LEGAL500 EMEA 2022 RANKING IN THREE CATEGORIES

KIELTYKA GLADKOWSKI humbly boasts its success.

We have been ranked in the Legal500 EMEA 2022 ranking in the following categories:

Data privacy and data protection

Private client

Healthcare and life sciences

 

Our entire team is very grateful to all our Clients for reviews and assessment. The success would not be possible without our Clients.

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