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EU Parliament Prepares to Discuss Reauthorization of Two Regulatory-Focused Programs

Posted 29 August 2013 | By Alexander Gaffney, RAC

Members of the EU Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) have been on hiatus for much of the summer, tabling legislative plans on a wide array of regulatory topics including medical device legislation and transparency measures. But with their recess set to soon end, the committee has released a draft agenda of an upcoming meeting detailing new policies on two topics of regulatory interest: Clinical trials and product innovation.

Neglected Diseases

The first of these items is a clinical trials partnership program between the EU and so-called "developing countries." The European and Developing Countries Clinical Trials Partnership (EDCTP), as the program is known, was established in 2003 as a means to address malaria, tuberculosis and HIV/AIDS in developing countries under the United Nation's (UN) Millennium Development Goals.

The program is intended to spur and accelerate the development of clinical trials for treatments for the diseases noted above, as well as supporting basic research and capacity building and accelerating the development of new drugs for use in sub-Saharan Africa.

ENVI notes that drug-resistant versions of the diseases have spurred a new need for medical products, as many products used in the past are no longer effective. Moreover, "Most of the new drugs and vaccines under development, however, are stuck at the stage of early clinical development," ENVI writes in a report. "This is mainly due to the significant costs involved in the clinical development and testing needed in humans to prove the effectiveness and safety of new or improved medical interventions."

In other words, this is in many ways a regulatory problem, and one with three primary problem drivers:

  • The regulatory costs are not outweighed by the eventual return on investment for profit-driven companies.
  • Many countries where diseases are most prevalent have a weak clinical research capacity.
  • Public support for trials and research is weak or fragmented.

Now ENVI is looking to address ongoing problems with the program by launching a second round of EDCTP with the goal of investing EU funding more efficiently.

ENVI explained that it aims to achieve four specific objectives through the new plan:

  • increase the number of new or improved medical products, including at least one new medical intervention, 20 candidate medical interventions and dozens of new treatment guidelines
  • strengthen clinical capacity in sub-Saharan countries in line with international ethical norms
  • coordinate, align and integrate EU, African and international programs
  • leverage the expertise of the private sector

The plan is estimated to cost EUR 683 million through 2023.

IMI: Part Two

ENVI is also set to review a non-legislative proposal for a regulation, again for a program that seeks to account for regulatory difficulties while spurring innovation. The program, known as the Innovative Medicines Initiative Joint Undertaking (IMI 2) is intended as a continuation of the first IMI program, which worked to build research partnerships to improve the drug development process and ultimately deliver "better and safer medicines to patients."

ENVI notes that like the with the EDCTP program, the EU faces regulatory and drug development problems that are best addressed through a government-led, united approach.

"Because industry on its own will not invest due to these obstacles, and because public support from the Member States acting alone is too fragmented and cannot achieve the coordinated, long-term, large-scale, transnational, cross-sectorial effort required," it wrote in a report.

The IMI, by contrast, "can help the life-science industries to set a long-term research and innovation strategic agenda in a pan-European structure, create the necessary critical mass, leverage private investment, provide stable funding, facilitate knowledge sharing and reduce risk at lower costs," ENVI argued.

ENVI said the proposal would "build upon the achievements of the previous IMI JU," but offered little explanation of what differences might exist between the first and second versions of the program.

The ENVI meeting will take place on 5 September 2013.

ENVI Draft Agenda

Second European and Developing Countries Clinical Trials Partnership Programme: participation of the Union

Innovative Medicines Initiative 2 Joint Undertaking

Tags: ENVI, EU

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