The use of AI and machine learning solutions in drug manufacturing technologies with the use of machine learning and quantitative, high-throughput in vivo experiments; the EU regulations for advanced therapy medicinal products (ATMP) and the procedures for placing the most modern drugs on the world market by the European Medicines Agency.
The intensive development of medicine affects the medical regulatory law in the European Union, which should cover more and more new legal problems related to the increasingly common application of advanced solutions of artificial intelligence, machine learning, telemedicine solutions and cyber solutions to the technology of manufacturing medicinal products.
At the turn of the 21st century, technologies were gaining significant importance. Information technology was the fastest-growing influence on the lives of ordinary people, as more and more services became digitized, automated, and transferred to cyberspace. These included, for example, correspondence and electronic communication, such as email, developed from the mid-1960s to the 1980s. Banking, financial services, were also introduced electronically in the 1970s and 1980s, as were the sharing of works of art and the storage of various data in digital form. These services are linked to key areas of our lives, such as economics, privacy, and security. These same areas also attract criminals of various kinds, many of them members of organized crime groups or terrorist and sabotage groups, but not exclusively. Their activities are referred to, primarily colloquially, as cybercrime. However, this term presents significant challenges in defining its meaning, as it evolves with technological advancements. However, in criminal law, the requirement of legal certainty must be met, linked to the principle that there is no crime without law. For this reason, various attempts are being made to develop such a definition.
The Digital Omnibus is a comprehensive draft of two regulations of the European Parliament and Council, the most important part of a broader package of changes to data regulations (especially personal data) and those regulating the digital market in the EU. The changes aim to stimulate innovation and the development of the European artificial intelligence market, and to introduce solutions that could save businesses capital (estimated at up to €4 billion in total by 2029). The changes aim to ensure that businesses of all types, from factories to start-ups, spend less time and money on administration and maintaining the documentation required by current EU regulations.
A documentary letter of credit (L/C) is a form of non-cash monetary settlement made through a bank. It serves to protect the interests of the parties in commercial transactions, particularly in sales contracts. Its essence is the bank’s commitment to pay an appropriate amount of money upon receipt of specific documents, which are assumed to constitute confirmation of the obligation’s fulfillment. The use of letters of credit is now standard in international trade.
General information
From a legal perspective, a documentary letter of credit is a legal relationship between the parties (in the example of a sales contract) the importer (buyer), the exporter (seller), and the bank issuing the letter of credit (buyer’s bank). In some cases, the exporter may wish to utilize the services of its own bank, which can collect the letter of credit documents from the exporter or confirm the letter of credit (intermediary bank). In the sales contract (underlying agreement), the buyer and seller specify that payment for the goods will be made via letter of credit and specify which documents the seller will need to submit to the bank to receive the funds. The agreement commits one party (usually the buyer) to conclude a letter of credit agreement with a specific bank under specific terms. After issuing the letter of credit, the buyer deposits funds. After the seller obtains the documents specified in the sales contract, they submit them to the bank (directly or through an intermediary bank). After the bank examines the documents, the importer receives the funds immediately or after a period specified in the letter of credit agreement. The bank’s obligation to pay the funds is abstract in nature, which means that their payment is not dependent in any way on the underlying agreement, but only on the presentation of the relevant documents.
One of the characteristics of diseases and conditions is that different illnesses often affect people to completely different degrees and with completely different frequencies. With the advancement of modern medicine, organizations have begun to take a more serious look at the problem of rare diseases. However, the diagnosis and treatment of such diseases are still highly problematic. One of the problems associated with this is the low revenue from such drugs. Due to the fact that some diseases are very rare, the cost of the process of developing and introducing them to the market is disproportionate to the expected sales of such drugs. This happens because of a very narrow group of people affected by such diseases. Drugs for these rare diseases are called orphan drugs or orphan medicinal products (Orphan medicinal products).
