The European Union on April 26 has released a draft of the probable and proposed revamp of its drug manufacturing laws. The changes have gone on to cause controversy among the manufacturers, with some even opining that they might as well leave the region if the laws actually take effect. That said, as per the announcement made by Stella Kyriakides, the EU Health Commissioner, the transformation will go on to provide EU citizens with more accessible, affordable, and novel medicines.
It is well to be noted that the reforms will fall within the wider EU health plan from 2021 to 2027, in which one of the objectives is the affordability of medicines for members. The revision aims to address the limitations of the industry and, at the same time, increase the supply chain within Europe so that there is more access to the medicines. The step also looks into addressing environmental challenges and taking tangible action when it comes to antimicrobial resistance.
The anticipation is that these changes might as well benefit not just Europe but also third parties of the EU, for instance, the associated countries, by sharing a more robust global supply chain from Europe across the rest of the world.
The program is going to have changes when it comes to data exclusivity, which means that other companies will be able to make use of the work done by their competition sooner than in the present scenario. Significantly, the public has viewed these changes more positively after many were upset at how the healthcare sector has gone on to struggle right from the time the pandemic began.
That said, the changes have also prompted some pushback from the drug manufacturing sector. Many of the costs are directly passed on to the manufacturer, with some even giving serious thought to moving away from Europe. This attitude is indeed at its peak, as there happen to be more profitable markets in certain other countries, like the largely unregulated ones in the US and China. According to the CEO of a pharmaceutical major, sharing data within such a time frame can have a damaging impact on Europe.