European Countries Urged To Boost OTC Profile In Health Care Systems

EU Health Commissioner John Dalli expects the region’s growing health care budgets and economic crisis to lead governments to restructure and impose more responsibility on consumers for health care costs. A self-medication working group launched in France will look at easing Rx-to-OTC switches.

European Union member states should lead the way in making the self-care industry a cornerstone of Europe’s health care systems because EU policy makers appear resistant to new initiatives, according to EU officials and drug industry stakeholders.

At the 48th annual General Meeting of the European Self Medication Industry (AESGP), EU Health Commissioner John Dalli said he expects growing health care budgets in Europe and the region’s economic crisis to lead governments to restructure and impose more responsibility on consumers for their health and wellness and associated costs.

Dalli noted that a recent European Commission report analysing the economic and budgetary impact of an aging population over the longer term suggested current EU members’ health care policies are unsustainable. Under current policies, age-related public expenditure, covering health and other supporting areas, would increase by around 4% to around 29% of gross domestic product between 2010 and 2060. Health care budgets would be roughly a third higher than today.

While changing the system is essential and patient responsibility must increase, changes cannot come at the expense of safety, Dalli added.

“Medicines need to be safe, but they also need to be available,” he said. “Otherwise, we are defeating our purpose.”

Noting that determining the status of medicine availability in Europe could provide a basis for a gradual shift toward wider access to OTCs, Dalli said he has initiated a study to analyze:

• to what extent patients in member states, particularly smaller countries, face availability issues
• identify factors that lead to restricted availability
• determine how, and to what extent, recent changes and implementation of EU pharmaceutical legislation have served to alleviate such problems.

“I want to know how we can best use the regulatory tools at our disposal in order to ensure optimal availability of medicinal products, in the interest of patients and public health,” Dalli said.

French Ray Of OTC Hope

Neither the European Parliament nor the EC has made proposals to propel Europe’s OTC market forward, particularly for making OTC switches easier.

But there is one ray of hope from France’s National Agency of Medicines and Healthcare Products Safety. Director General Dominique Maraninchi said he is setting up a dedicated self-medication working group, the first of its kind in Europe and welcomed by the OTC sector.

The working group would collaborate with other scientific bodies within the French agency to answer questions on risk profiling and facilitating easier Rx-to-OTC switches.

Maraninchi noted at the AESGP conference in Nice, France, June 6-8, that national switches are infrequent and centralized switches are particularly problematic, and that safety issues are a key factor in making any switch work. Only by achieving increased transparency, at the EU and national levels, would the safety issues improve, he said.

The French official agreed with Dalli that patient education about the self-care sector was essential to its success and could help alleviate pressure on national health care budgets. But he added that EU member states also should re-evaluate how they educate all stakeholders – including pharmacists and physicians – about the benefits of self-care.

Industry Wants More

The OTC industry, however, wants EU and member state authorities to do more to further the cause of the self-care sector.

Roger Scarlett-Smith, president of GlaxoSmithKline Inc.’s Consumer Healthcare Europe division, argued that the lack of uniform drug policies across the EU keeps the OTC industry at a disadvantage, in addition to impeding self-care in some countries. The creation of a uniform market and a sustainable self-care climate would maximize drug availability and optimize pharmaceutical benefits, he said.

“The area of nonprescription medicines suffers from many deficits in relation to the single market, and it is important that they are addressed by decision-makers,” Scarlett-Smith said.

He added that among the problems are the differences in drug advertising regulations across EU member states. For instance, GSK is allowed to offer online discussion boards for its weight-loss drug alli in only nine member countries.

“We therefore need public advertising for all nonprescription medicines in all media all over Europe,” said Scarlett-Smith.

The GSK executive and other European pharma industry stakeholders also argued that the lack of uniformity among EU member states in accepting European Medicines Agency decisions to switch Rx products to OTC status significantly hinders drug firms. Although a firm’s switch application could be approved through EMA’s centralized process, each EU member state retains authority over whether the drug is available OTC or remains Rx (Also see "Switch Obstacles In Europe Threaten OTC Industry Growth – GSK Exec" - Pink Sheet, 14 Nov, 2011.).

Only So Much Harmonization

While harmony in EU members’ drug policies does not extend to drug advertising or allowing OTC access, adjustments implemented July 2 to EMA’s process for deciding pharmacovigilance imposes some uniformity across member states’ drug policies and could help firms keep more Rx and OTC drugs available throughout the region.

The European Parliament in 2010 passed legislation to change the process so disagreements between member states and drug firms about the safety of products could be referred to EMA for a rapid assessment, regardless of whether the product was nationally authorized or approved through the EU centralized process (Also see "European Pharmacovigilance Update Still Causing Concern" - Pink Sheet, 24 Feb, 2012.).

Dalli said the EC designed the updated evaluation process to adapt to a drug’s specific risk profile, which means that products with low-risk safety profiles, such as OTCs and some Rx drugs, will not be subject to the same rigorous assessments as medicines with high-risk profiles.

The process “has the potential of significantly reducing red tape by better adapting the system to the risk profile of the product. There is no need, for example, to undertake a systematic review of all authorized medicines whose safety profile is well-known,” he said.

The process will be facilitated by the Pharmacovigilance Risk Assessment Committee, established as part of EMA by the legislation and meeting this month for the first time.

PRAC is tasked with ensuring that any drug-related risk identified in an EU member state leads to appropriate action in all others. The committee will advise EMA’s Committee for Medicinal Products for Human Use – for centrally authorized products – and the Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human – for nationally authorized products. Both the CHMP and Mutual Recognition groups retain power of approval for a product.

Previously, member states could choose to accept or reject CHMP recommendations. If member states represented in CMDh cannot reach agreement in implementing a PRAC recommendation, they will vote on the question and forward the result to the European Commission, which will decide on a course of action.

The EC has indicated the scope of the process might expand beyond safety issues to include, for example, efficacy and quality topics.

Safety issues, however, will remain the primary focus, said European Parliament VP Dagmar Roth Behrendt.

While EU member states must refer to the PRAC information on serious side effects linked to pharmaceuticals, Roth Behrendt emphasized submitting only necessary information. A backlog of work for PRAC could tie up a medicine in the investigative process for a significant period, leaving the product under a cloud, even while it remains on the market.

“Some side effects are normal side effects and if there was not one out of 100, but two out of 100, then that is not a reason for referral,” Roth Behrendt said.

Dalli pointed out another EU pharmaceutical regulation, the July 2011 Falsified Medicines Directive, has had little impact on the OTC sector, partly because regulators and industry stakeholders agree that adverse events are more likely from the more inaccessible and expensive products.

Similarly, a rule the Directorate General for Health is working on to require a unique identifier for outer packaging to guarantee the authenticity of medicines considered to be targets of falsification also should not affect OTC manufacturers. Nonprescription products will be exempted unless there is some exceptional circumstance, Dalli said.

“I am firmly aware of the importance of this element for your sector, and I can reassure you that I am convinced that we need to avoid any undue burden which does not increase patient safety,” he said.