Advance European
Aiko Bartels
The pre-arrival security and safety programme will support effective risk-based customs controls whilst facilitating free flow of legitimate trade across the EU external borders. It represents the first line of defence in terms of protection of the EU internal market and the EU consumers. The new programme will remodel the existing process in terms of IT, legal, customs risk management/controls and trade operational perspectives.
The EU's new advance cargo information system ICS2 supports implementation of this new customs safety and security regulatory regime aimed to better protect single market and EU citizens. It will collect data about all goods entering the EU prior to their arrival. Economic Operators (EOs) will have to declare safety and security data to ICS2, through the Entry Summary Declaration (ENS). The obligation to start filing such declarations will not be the same for all EOs. It will depend on the type of services that they provide in the international movement of goods and is linked to the three release dates of ICS2 (15 March 2021, 1 March 2023, and 3 June 2024).
Yesterday finished the third session of the International Negotiating Committee (INC) on Plastic Pollution which took place between 13-19 November in Nairobi, Kenya. UN Member States decided to go ahead with the preparation of a draft treaty text before the next round of negotiations in April. With this step, the process leading to a legally binding global agreement on plastic pollution, which was initiated in March 2022, is entering a more advanced phase. Full textual negotiations can start at the next INC meeting in Canada in April 2024.
The EU is taking a leading role in global action on plastics, as demonstrated by its support for the setting up of the High Ambition Coalition to End Plastic Pollution. The Coalition advocates for an ambitious and effective treaty covering the entire plastics lifecycle to end plastic pollution by 2040.
Whilst plastic materials have become an integral part of our lives, the way in which plastics are produced, used and disposed, is harmful for the environment. Each person in the EU generated an average of 35.9 kg of plastic packaging waste in 2021. At the same time, the recycling rate was only 39.7%. Moreover, the overall amount of plastic waste continues to steeply increase, with plastic production expected to triple by 2060. Between 2011 and 2021, the amount per capita of plastic packaging waste generated in the EU increased by 26.7%.
In addition, some ATMPs may contain one or more medical devices as an integral part of the medicine, which are referred to as combined ATMPs. An example of this is cells embedded in a biodegradable matrix or scaffold.
As with all medicines, the Agency continues to monitor the safety and efficacy of advanced therapy medicines after they are approved and marketed. The Agency also gives scientific support to developers to help them design pharmacovigilance and risk management systems used to monitor the safety of these medicines.
In October 2017, the European Commission and EMA published a joint action plan on ATMPs, which aims to streamline procedures and better address the specific requirements of ATMP developers.
The Agency's Committee for Advanced Therapies (CAT) plays a central role in the scientific assessment of advanced therapy medicines. It provides the expertise that is needed to evaluate advanced therapy medicines.
During the assessment procedure, the CAT prepares a draft opinion on the quality, safety and efficacy of the advanced therapy medicine. It sends this to the Committee for Medicinal Products for Human Use (CHMP)">Committee for Medicinal Products for Human Use (CHMP). Based on the CAT opinion, the CHMP adopts an opinion recommending or not the authorisation of the medicine by the European Commission. The European Commission makes its final decision on the basis of the CHMP opinion.
Stem cells are naturally occurring cells in the body that have the ability to divide and produce a range of different cell types. Stem cells are important in the growth and development of the body, as well as in repair after injury.
Stems cells are categorised as ATMPs when these cells undergo substantial manipulation or are used for a different essential function. They can be somatic-cell therapy products or tissue-engineered products, depending on how the medicine works in the body.
In February 2011, the Agency published a Reflection paper on stem cell-based medicinal products. The paper stressed the fact that developers of stem-cell based medicines need to pay close attention to the way the medicines are manufactured, to ensure that the final medicine is as consistent and reproducible as possible. Pre-clinical and clinical testing also needs to take account of the cells' properties, ensuring that the possible risks of tumour development and rejection by the body are studied adequately and balanced against their benefits for patients.
The reflection paper was adopted by the CAT on 14 January 2011. This followed a public consultation between March and June 2010 and discussion at a public workshop in May 2010 involving 230 participants from academia, industry and regulatory authorities.
Advanced technologies present enormous growth potential for Europe. Technologies such as the Internet of Things, industrial data, advanced manufacturing, robotics, 3D printing, blockchain technologies and artificial intelligence offer a range of opportunities that will enable European industry to expand its leadership in the emerging markets for the products and services of the future.
EU businesses are not taking full advantage of these advanced technologies or the innovative business models offered by the collaborative economy. The state of the uptake of advanced technologies by industry varies across sectors and between EU countries and regions. There are also large disparities between large companies and small and medium-sized enterprises (SMEs). To improve this situation the European Commission is working in the following areas.
Artificial intelligence (AI) is one of the most strategically important technologies of the 21st century and is expected to bring higher productivity, improved corporate performance and economic growth. More importantly, these technologies have the potential to create solutions for pressing societal challenges that we wish to address. To keep up with the evolution of AI and capture the competitive advantages it can yield, companies, in particular SMEs, need further support. Therefore, we are exploring the most critical AI applications to accelerate its deployment and adoption by SMEs within strategic value chains.
Big data and digital platforms have grown dramatically over the past decade and are radically transforming every industry. In spite of huge economic potential, data sharing between companies has not taken off at sufficient scale. So the Commission seeks to identify and address any undue hurdles hindering data sharing and the use of privately-held data by other companies. On business-to-business data sharing, we are deploying two big data pilot projects to explore the innovation potential and innovative business models created by sharing data between data-producing/controlling entities and third-party businesses.
The Strategic Policy Forum on Digital Entrepreneurship was a policy think tank that brought together thought leaders from business, academia and politics in the area of digital transformation and entrepreneurship. It advised the European Commission on policy issues and actions to foster digital transformation, and promoted the development of policy by EU countries at national and regional level. The Strategic Policy Forum drew up several reports on how to accelerate the digital transformation of European industry and enterprises.
Unlike rail passes, it's generally easy to buy point-to-point train tickets right at the station (whereas most rail passes aren't widely available in Europe). But it can be smart to buy in advance for certain trains and destinations, especially if your dates are set and you don't want to risk a specific train journey selling out, or if you're hoping to land an advance-purchase discount.
You have three main options for buying point-to-point tickets: through a US-based retailer before leaving home (we even sell them right here), through the website of one of Europe's national railways, and in person at Europe's train stations (and at some European travel agencies). For big discounts, buy tickets up to three months ahead (just note that these tickets are nonrefundable and nonchangeable).
The easiest way to get train tickets online is to buy them through ricksteves.com (after all, you're already here!). Virtually all US-based websites and travel agents sell European train tickets for the exact same prices you'll find here.
Many European national rail companies allow customers to buy tickets online at the going European price (usually for faster classes of trains for which reservations are required, or at least recommended).
Not all national-railway sites are created equal: While many are fairly easy to navigate (see my tips for using the well-designed British, French, German, Irish, Italian, Swedish, and Swiss railway sites), some are difficult for foreigners to use (notably the Austrian, Norwegian, and Spanish railway sites; PayPal solves some credit-card difficulties).
Your ticket may be a QR code or barcode on your phone, an emailed confirmation code redeemable at the station (in the same country that operates the website you bought it on), or a print-at-home document. Online tickets are valid for a specific date and time and have strict refund restrictions, so read the fine print carefully.
Once in Europe, you can simply get tickets at the station (or on your phone), usually without much fuss, either on your day of travel or in advance (see my tips for buying tickets in European train stations). This is the best option if you'd prefer to keep your itinerary more spontaneous. You can even get tickets for trains in another country: For example, if your trip starts in Paris, you can buy your Berlin-to-Prague ticket at any Parisian train station. Tickets bought at train-station windows tend to be easier to change (or have refunded) than tickets bought online.
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