Farmaindustria presents improvements to the Medicines Bill to prepare healthcare for innovation over the next 20 years
Farmaindustria presents improvements to the Draft Medicines Bill to prepare healthcare for innovation in the next 20 yearsThe future law should promote greater investment in healthcare, focusing on biopharmaceutical innovation, R&D and promoting improvements in the availability of new medicines in our country, guaranteeing compliance with the 180-day deadline for the decision on price and financing, in accordance with EU regulations.
Ensure the maintenance of drug production in Europe and in Spain in order to promote the necessary open strategic autonomy, which is compromised by proposals included in the Preliminary Draft, such as the selected prices.
Farmaindustria.es
Farmaindustria has presented a series of allegations to the Draft Bill on Medicines and Medical Devices, presented by the Ministry of Health and approved on 8 April by the Council of Ministers in the first round. These allegations seek to introduce improvements to the current text aimed at transforming our healthcare system and preparing it for the next 20 years. The Association believes that there is a unique opportunity with this future law to take advantage of the important innovations that will take place in healthcare and medicine, including the use of data science and artificial intelligence in the coming years.
For this reason, the proposed improvements seek to boost greater investment in healthcare, with a commitment to biopharmaceutical innovation, new technologies and the production of medicines in Europe and Spain, while at the same time ensuring that Spanish society has the best possible innovative treatments within its reach and on time.
“Medicines should not be seen as a public expenditure item, but as an investment strategy. The main objective is to improve the health of the population, while also contributing to the sustainability of the welfare state; it generates savings in other budget items such as hospitalisations and sick leave, and contributes to productivity and employment, and therefore to economic growth,” says Farmaindustria’s president, Fina Lladós Canela.
‘In a current context where Europe’s competitiveness is declining in the face of the push in the field of biomedical R&D by other regions of the world, especially the US and China, we need regulatory developments that strengthen intellectual property to attract investment to the country and the continent,’ she says.
To encourage such investment in R&D, it is essential to boost access to innovation. And in Spain, although the situation has improved in recent years and timeframes have been reduced to an average of 616 days, promoting a model that consolidates an improvement in patient access to new drugs is still an unresolved issue. For this reason, Farmaindustria has proposed to guarantee in the Draft Bill the inclusion of procedures for the necessary compliance with the 180-day deadline for the decision on financing and price (EU Transparency Directive), which should be even shorter (90 days) in the case of medicines for diseases for which there is no treatment alternative or which represent a relevant therapeutic benefit, by means of accelerated financing.
Another of the proposals made by Farmaindustria focuses on reducing the delays in the availability of innovative medicines caused by the public procurement procedure. The application of the usual public procurement procedure is not adequate for the acquisition of essential goods such as medicines. For this reason, it would be necessary to regulate a special procedure for the purchase of exclusive medicines that is flexible and simple and avoids unnecessary delays and bureaucracy.
The Association has also put forward measures to ensure the principle of territorial equality and the right of all citizens to obtain medicines on equal terms. Performing a quality scientific evaluation, during the phase prior to the funding decision, can avoid successive evaluations both at regional and hospital level, and this makes it possible to speed up the availability of medicines for patients.
This Draft Bill should take up the major transformational lines that are already being imposed by the biomedical and technological revolution, but not only does it not reflect the vision of medicines as an investment, but it is impregnated with an economic vision centred mainly on short-term savings policies. Proof of this is that it includes continuous references to the need for reports from the Government’s Delegate Commission for Economic Affairs (CDGAE) even on matters unrelated to economic and budgetary issues. Most of the financing and pricing criteria have a clinical, healthcare and social dimension that should not be attributed to a body such as the CDGAE.
Strengthening the productive fabric
Farmaindustria has also introduced improvements to the text in order to strengthen the industrial fabric and promote the open strategic autonomy that Europe needs through a clear reinforcement of drug production. On this point, it has proposed replacing the new system of selected prices included in the Draft Bill with a system of dynamic prices, aimed at promoting competition and ensuring the supply of medicines, while guaranteeing the necessary predictability and legal certainty for companies. ‘We are already a leading country in clinical research, and in production, our more than 100 manufacturing plants for medicines for human use make us one of the European countries with the greatest manufacturing potential at a time when medicines have proven to be a strategic and security asset for States,’ says Lladós.
The text also contemplates the extension of the contributions to the National Health System already made by pharmaceutical companies for sales in pharmacies to the sale of medicines to hospitals. This contribution would be in addition to many others already made by the sector, which in 2023 and 2024 amounted to more than 2,000 million euros. In any case, it would be necessary to improve transparency on the destination of this contribution so that it has an impact on the improvement of the health system and the welfare of patients.
Hand outstretched for collaboration
This Draft Bill generates great uncertainty for the sector in a very tense international context for the pharmaceutical industry: the inflation resulting from the war in Ukraine, which entailed more than 1,500 million euros in additional costs in just two years; the uncertainty created by the review of European pharmaceutical legislation and the new environmental regulations; the instability resulting from the potential imposition of tariffs by the US which, although for the moment leaves medicines out, will have repercussions on global production chains.
‘The allegations presented by Farmaindustria are proactive, with the aim of always being at the disposal of the Ministry of Health to improve this Law, because it is a great opportunity to adapt the world of medicines to the technological revolution we are experiencing and that should help us to improve the health of citizens and promote a strategic sector for this country’, concludes the president of Farmaindustria.
