By Desmond Hinton-Beales and Ruth Marsden - 8th November 2011
There are inequalities in access to medicines and it is policymakers that must meet these challenges
Marisa Matias, MEP
Patient safety should be the primary concern when considering the impact of innovative medicinal products, a roundtable discussion has heard.
The event, which took place in the European parliament on Tuesday and was organised by the Parliament Magazine and Europabio in association with Novo Nordisk, looked at the relationship between patient safety and biological medicines.
Biologic medicines, such as insulin, are increasingly being used for treatment, but different versions of the drug produced by different companies are not identical in structure or effect.
These increasingly subtle differences between medicinal products are causing problems, as it becomes harder to predict how these medicines will interact with other treatments.
Portuguese GUE/NGL deputy Marisa Matias, who hosted the event, said that "patient safety is a key concern", and called for greater "articulation between member states and institutions".
Matias highlighted the "complexity of these medicines" and the issues surrounding them, but added that "if there are more innovative and effective medicines available" then they should be accessible.
She said, "There are inequalities in access to medicines and it is policymakers that must meet these challenges. It is surprising that the commission thinks it can support competitiveness and improve quality of life."
Patient safety
Foundation of European nurses in diabetes (Fend) president Anne Felton said that when it comes to patient safety there are challenges in the area of "reporting of trials and their interpretation".
Felton cited a study which showed that "women who take the pill for 10 years show a 50 per cent reduction in ovarian cancer".
However, Felton said the study failed to communicate was that, while cases of ovarian cancer dropped, cases of breast cancer, which is far more common, increased significantly.
"Quality, safety and efficacy" should be key watchwords, she added, but underlined the difficulty of ensuring this due to national variations in the EU.
"We need commonality across Europe for these factors," she said.
Felton also highlighted the effect of the free movement of people across the EU and the various language barriers this throws up in relation to patients' ability to understand medical prescriptions.
"We need clear guidance, record making, proper reporting and feedback about adverse reactions to medication. However, we don't want to terrify people so they won't take any medicine," she said.
Felton stressed that efforts must also be made to improve the work of those prescribing medicines, as "there are more medication errors from licensed practitioners than by the patients themselves".
Stéphane Hogan, of DG Research and Innovation, said, "2011 has seen investigative driven trials, adverse drug reaction research and the adaption of specific antibody drugs for children" from the commission.
"Efficacy and safety" were highlighted by Hogan as the main focus for seventh framework programme (FP7) funding in this area.
Hogan told participants that support for clinical trials would remain a part of FP7 plans in 2012 and 2013, along with research for new methodologies and adverse immune reaction.
Biosimilars
Inger Mollerup, the vice-president of Novo Nordisk, said no two biosimilar products can be exactly the same, so traceability is particularly important when it comes to medicines.
"We must be able to identify which product the patient was treated with and be able to trace it back to the manufacturer," Nordisk added.
Biosimilar products are new biological products which are analogous to an already authorised medicine, but not identical.
Discussing the safety issues taken into consideration when prescribing biological medicines, Mollerup, who has years of experience in developing processes for the manufacture of recombinant proteins, warned that the process is extremely complex and unique.
She said, "We must ensure products have highly similar molecular structural features to the reference medicine to ensure clinical safety and efficacy.
"Full comparability is needed, quality, non clinical and clinical."
Mollerup went on to tell the event that biosimilars should not be considered as identical to their biological reference product and the decision to treat the patient should therefore be made by a qualified healthcare professional.
"The safety of biologics on our patients are key issues we must consider," she added.
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