The European Medicines Agency (EMA) has insisted that the concerns raised about its scientific advice given to pharmaceutical companies stem from a flawed understanding of the activities of the agency and its partners in this area.
A coalition of European medicines advocates, including Health Action International (HAI), has criticized the EMA for providing confidential advice to pharmaceutical companies in exchange for fees, to give them guidance on their development plans for new drugs. The coalition worried that the agency is attempting to extend this practice to national health technology assessment bodies in the European Union, according to a report published on July 15 by thepharmaletter.com.
In a statement sent to appliedclinicaltrialsonline.com, EMA says it welcomes all comments submitted by stakeholders about its public consultation on its best practice guidance for pilot parallel scientific advice procedures involving the EMA and health-technology-assessment (HTA) bodies.
“Scientific advice is an important tool used by the EMA, EU Member States and other international regulators to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients,” noted the agency. “Scientific advice helps the company to make sure that it performs the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorization application.”
EMA concedes that seeking and following scientific advice increases the probability of a positive outcome for a marketing application, but says it is not always the case. Scientific advice is prospective in nature; it focuses on development strategies rather than pre-evaluation of data to support a marketing-authorization application, and it is not legally binding on the agency or on the sponsor, continued the statement.
“Scientific advice is also a valuable instrument to support SMEs, as well as to assist in the development of new medicines for orphan (rare) diseases, pediatric medicines and advanced therapy medicinal products. For these categories, reduced scientific advice fees apply,” explained the agency.
Also, some new medicines authorized by the European Commission based on the EMA’s scientific opinions fail to be reimbursed and/or used as expected because they fail to match the requirements of HTA bodies. “Therefore there is a clear need to initiate early dialogue between medicines developers, the EMA and HTA bodies to discuss and agree on a development plan that generates data that both parties can use to determine a medicine's benefit-risk balance and value. This strong interaction is critical to enable innovation to reach patients, and ultimately for the benefit of public health,” noted the statement.
Regulation 726/2004 foresees that the agency must provide scientific advice to companies, and in fact the Scientific Advice Working Party is mandated in the legislation. This working party includes patient representatives for its procedures.