EFPIA response to December EPSCO meeting

EFPIA has today [Friday 9 December] responded to the EPSCO quarterly meeting. 
Today’s Council meeting provided an informative update on the progress of numerous health-related files and saw the adoption of long-awaited cancer screening recommendations. EFPIA Members very much welcome the decision which we believe will help improve time to diagnosis and subsequent treatment for patients across the EU. 
On Cancer Screening recommendations 

Nathalie Moll, EFPIA Director General, said:  
“EFPIA and its Oncology Platform very much welcome the adoption of the Cancer Screening Recommendation. This is an important milestone towards optimization of the cancer care pathway and a fantastic first step towards the implementation of the EU Beating Cancer Plan. 
By improving existing screening guidelines for breast, colorectal and cervical cancer, and introducing new screening programmes for lung, prostate, and gastric cancer, Europe can reduce inequalities in cancer care and improve outcomes for cancer patients. 
However, we believe that despite clear evidenced based recommendations from SAPEA, the wording of the final text has been diluted compared to the Commission’s initial proposal. Timely cancer diagnosis ensures that patients can be treated early and with higher chances of survival, benefiting both the patients, their families and ultimately to society through the ability to live and work in better health. 
It is important that Member States remain committed to the implementation of the revised guidelines and that the European Commission support the coordination and monitoring of the screening efforts across the EU. We look forward to working with partners to ensure that the recommendations are implemented in full and, where necessary, adapted to keep up with the pace of scientific advancement.” 
On Council conclusions on vaccination 
Sibilia Quilici, Executive Director, Vaccines Europe, said:  
"Vaccines Europe welcomes the Council Conclusions on Vaccination, which rightly call for coordinated action against vaccine hesitancy and misinformation, one of the biggest health threats nowadays. The call from the Council to Member States to put in place campaigns for adult vaccination programmes is an important policy priority to protect adults against Vaccine-Preventable Diseases, support public health goals, and contribute to building resilience of our healthcare systems and societies." 

On advanced purchase agreements for Vaccines  
Sibilia Quilici, Executive Director, Vaccines Europe, said:  
“EFPIA and Vaccines Europe understand the constraints on the economies of all EU Member  States caused by the COVID-19 pandemic, the energy crisis, the war in Ukraine, and hence, the pursuit for short and long-term cost-containment solutions. 
However, Europe is about to enter the winter season, and we should not lose sight of the perils  of current three life-threatening seasonal respiratory diseases: COVID-19, seasonal influenza,  and respiratory syncytial virus (RSV). With 54% of EU population up-taken the first COVID-19  vaccine booster, and only 11% the second booster, we could expect that public health systems will be put to the test once more in the weeks to come. Sustainable immunisation financing is essential to ensure efficient protection against vaccines-preventable diseases, and immunisation budgets should be protected from any fiscal consolidation measures. 
Advance purchase agreements were an important mechanism to secure more equitable access to Covid-19 vaccines in response to such an extraordinary, cross-border public health challenge. Our member companies are working continuously to produce new vaccines responding to the emerging variants, in addition to the normal routine vaccines. But providing the vaccine is only one step in the equation. An EU-coordinated vaccination strategy is needed as much as an EU vaccine strategy. 
To tackle these challenges, we call on Member States to increase their efforts in deploying all necessary tools to protect their populations, reinvigorate vaccination initiatives and information campaigns, encourage citizens to be vaccinated against COVID-19 and influenza to support the resilience of our healthcare systems and societies.” 

On the Transfer of Exclusivity Voucher Extension proposal 
Nathalie Moll, said:   
“We appreciate that a number of organisations and Member States have stepped into this important debate. And there remains a consensus on the need for novel incentives. Independent research as well as our own analysis shows that transferable exclusivity vouchers would provide a strong incentive for companies to research and develop new antimicrobials, providing a sustainable pipeline. Moreover, it would save individual Member States hundreds of millions of Euros in AMR related costs. 
It is essential that a system to incentivise research in a sustainable manner is delivered within the pharmaceutical legislation otherwise we are no closer to preventing the 400,000 annual deaths and the substantial economic costs related to AMR. We remain open to all options that could drive research and development and we will continue to engage in constructive dialogue with our partners on this urgent topic. 
On European Health Data Space (EHDS) 
Nathalie Moll, Director General, EFPIA said:  
“The legislative proposal on a European Health Data Space (EHDS) and respective horizontal proposals provide an unprecedented opportunity to shape the future health data and digital ecosystem.  More effective use of health data is necessary to drive greater sustainability in the healthcare system and to increase the innovation and productivity of the EU economy. It is of paramount importance that EHDS merits full support and encourages implementation by all Member States.  
It will be critical to ensure consistency across different Member States to ensure interoperability, appropriate level of data protection and harmonised processes for accessing data for secondary purposes such as scientific research and innovation. EFPIA supports the ambition of the proposal but is concerned by lack of assurances on the conditions for sharing data, including clinical trial data and around how IP and trade secrets will be protected when data is requested from a data holder.  
The current text does not provide clarity on the scope of the data that is covered and consistency with horizontal legislation such as interpretation of key definitions i.e. data holder. Further clarification is needed to avoid causing confusion about roles and responsibilities.”