MaltaToday previous editions

MaltaToday 1 December 2021 MIDWEEK

Issue link: https://maltatoday.uberflip.com/i/1433519

Contents of this Issue

Navigation

Page 14 of 15

15 maltatoday | WEDNESDAY • 1 DECEMBER 2021 NEWS These articles are part of a content series called Ewropej. This is a multi-newsroom initiative part-funded by the European Parliament to bring the work of the EP closer to the citizens of Malta and keep them informed about matters that affect their daily lives. These articles reflect only the authors' view. The European Parliament is not responsible for any use that may be made of the information it contains. MARGRETHE Vestager, the EU's com- petition and digital policy chief, has urged the European Parliament and European Council to approve rules to curb the pow- er of Big Tech as a matter of urgency, re- ported The Irish Times. Speaking ahead of the FT-ETNO Tech and Politics forum on Monday, Vestager said: "It's important that everyone realises that it is best to get 80% now than 100% never. This is another way of saying that perfect should not be the enemy of the very, very good." Vestager's appeal comes after almost a year of discussions among EU regulators and legislators, who have struggled to agree on the fine print of the Digital Mar- kets Act (DMA) and the Digital Services Act (DSA). The DMA was created to force so-called gatekeepers, such as Google, to ensure more equal terms on their online platforms, while the DSA seeks to clarify the way large online companies should keep illegal content off their platforms. Vestager left open the possibility of leg- islators reviewing the new rules once they are enacted, which would mean bringing them before the EU Parliament and council again. "We won't let another 20 years pass be- fore we may revisit [the legislation]. With the parliament and the council's position we can make a very strong rule book that can be enforceable soon," Vestager said. "We have so many companies out there waiting and asking for a level playing field." The latest draft of the DMA was voted through by MEPs on the European Parlia- ment's Internal Market and Consumer Pro- tection Committee (IMCO) on November 22, ahead of a plenary vote in December. Vestager wants to push big tech regulation through EU prepared to tackle ongoing pandemic challenges, EMA chief says HEALTH MEPs quizzed the EMA's Executive Director on Tuesday on the current situation around COVID-19 vaccines and therapeutics, as well as the Agen- cy's future role. In light of increasing COVID-19 cases across the EU and concerns raised by a new variant, mem- bers of the Environment, Public Health and Food Safety Com- mittee focused the debate on COVID-19 vaccines, recent de- velopments in COVID-19 thera- peutics and the Agency's capacity to deal with current and future challenges. MEPs asked wheth- er the agency is prepared to deal with new variants, about the use and effectiveness of booster vac- cines, clinical trials transparency and coordination with European and international counterparts, including the new Health Emer- gency Preparedness and Re- sponse Authority (HERA). Emer Cooke, Executive Direc- tor of the European Medicines Agency (EMA) reassured MEPs that the EMA is prepared to deal with the current challenges posed by the pandemic. Existing vaccines have remained effective until now, with studies showing that an additional dose or booster ensures extended immunity, she added. Should a scientific deci- sion be taken to adapt them, the Agency already has in place guid- ance for manufacturers that plan to modify vaccines to address var- iants. The agency also has a legal framework to authorise adapted vaccines more quickly, which would ensure they are approved within a 3-4 months period. The EMA recently recommend- ed that a booster dose of the two mRNA-based COVID-19 vaccines (Comirnaty-BioNTech/Pfizer and Spikevax - Moderna) may be given to people with severely weakened immune systems as well as the general population over 18 years old, said Emer Cooke. Member states decide how these boosters should be rolled out depending on their vaccination campaigns and the capacity of their national health systems. Regarding clinical trials, Ms Cooke confirmed that the EMA is committed to being transpar- ent in publishing data, also in view of the application of the new requirements under the clinical trials regulation from the end of January 2022. On coordination with HERA, the EMA is current- ly preparing a memorandum of understanding, which will clearly outline the responsibilities of the two bodies and ensure they coor- dinate effectively. With regard to the EMA's ca- pacity to deal with its reinforced role, Ms Cooke informed MEPs that the Agency is still evaluating the impact of its new tasks. How- ever, the general situation is a concern, with the workload con- stantly growing since 2014 and the needs of human resources not being matched with financial resources. Emer Cooke, Executive Director of the European Medicines Agency

Articles in this issue

Archives of this issue

view archives of MaltaToday previous editions - MaltaToday 1 December 2021 MIDWEEK