The EMA being Transparent – Detective Week

The Principle of the European Medicines Agency is transparency

The main objectives of the policy by making clinical data available proactively, are to enable 

• public scrutiny,
• and application of new knowledge in future research, all this in the interest of public health. 

They say a high degree of transparency will take regulatory decision-making one step closer to EU citizens, and promote better-informed use of medicines. 

In addition, the Agency takes the view that access to clinical data will benefit public health in future. The policy has the potential to make medicine development more efficient by establishing a level playing field that allows all medicine developers to learn from past successes and failures. 

Furthermore, it will enable the wider scientific community to make use of detailed clinical data to develop new knowledge in the interest of public health. 

Access to clinical data will allow third parties to verify the original analysis and conclusions, to conduct further analyses, and to examine the regulatory authority’s positions and challenge them where appropriate. 

In addition, those who perform secondary analysis of clinical data published in accordance with this policy, are encouraged to provide the Agency with a copy of any article resulting from such secondary analysis before publication, in particular in those circumstances where the secondary analysis might result in the need for regulatory action to protect public health. 

This is a critical consideration in view of the Agency’s role and responsibilities for a timely review of all available information which might have an impact on the benefit/risk ratio of centrally authorised products. 

The Agency cannot guarantee that all secondary data analyses that are enabled by the policy will be conducted and reported to the highest possible scientific standard; this is not possible with a truly open approach. 

Allowing external parties access to clinical data held by the Agency will directly or indirectly affect different stakeholders’ rights, interests and values. 

In developing this policy the Agency had to consider a number of competing principles which needed to be carefully balanced in order to best ensure the overarching, long-term goal of protecting and fostering public health. 

These principles, as well as the Agency’s positions and views, are described below: 

• Protecting personal data: The protection of personal data is enshrined in EU legislation; it is a fundamental right of EU citizens. The policy has to ensure adequate personal data protection; it must be fully compliant with applicable regulations in the EU, in particular Regulation (EC) No 45/2001 and Directive 95/46/EC. 
There are ways and means to anonymise data and protect patients from retroactive identification. Yet, the Agency is primarily concerned that emerging technologies for data mining and database linkage will increase the potential for unlawful retroactive patient identification. The Agency, therefore, takes a guarded approach to the sharing of patient-level data, which is done to enable legitimate learning from sharing patient-level data while preventing rare but potentially damaging instances of patient identification. Furthermore, patients’ informed consent should be respected. The secondary analysis of personal data will have to be fully compatible with the individual privacy of clinical trial participants and data protection. 

• Protecting commercially confidential information (CCI): The Agency respects and will not divulge CCI. In general, however, clinical data cannot be considered CCI. The Agency acknowledges that there are limited circumstances where information could constitute CCI. European Medicines Agency policy on publication of clinical data for medicinal products for human use EMA/240810/2013 Page 4/22

 • Protecting the Agency’s and the European Commission’s deliberations and decisionmaking process: Regulators have a legal mandate to evaluate medicines. In doing so, they should only focus on the science and the best interests of patients. The decision-making process should be protected against external pressures from whatever direction. Once a decision has been reached, this consideration no longer applies. 

• Ensuring future investment in pharmaceutical research and development (R&D): Sustained and extensive pharmaceutical research activity is a precondition for future improvements in public health. The policy has no intention to negatively impact on the incentives to invest in future pharmaceutical R&D. It is designed to guard against unintended consequences, e.g. breaches of intellectual property rights that might disincentivise future investment in R&D.

So what should we request?

Come Back at 16.00 (British Summer Time) to find out.

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