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The 'Pharmaceutical Package' has arrived on approval; now the debate begins

An illustration of a 'Pharma Parcel' The pharmaceutical industry is quite happy taking care of business away from the limelight, quietly getting on with what it does best. In some ways this is understandable, as too often forays into the public eye seemed to place it in an unflattering light. The pharma sector is, after all, a unique and sometimes arcane industry. The European Commission's 'Pharmaceutical Package' has been long expected to present a deserved opportunity for the industry to take centre stage.

The Package seeks to bring together a number of crucial issues for industry. Enterprise Commissioner Günter Verheugen has described it as "a Communication and three legislative proposals with the overarching objective of ensuring that European citizens can increasingly benefit from a competitive industry that generates safe, innovative and accessible medicines."

Delayed and distracted
The Package presents the perfect opportunity for industry to demonstrate its commitment to patients as well as its role as a major contributor to European innovation. Yet as anticipation grew, delays mounted up. The Package was subject to what Harold McMillan wearily referred to as "events, dear boy, events."

First, a proposal for Animal Welfare legislation hit polarised opinions and had to be reviewed. Then it emerged that the Commission's DG Competition was planning to launch an interim report on pharma competitiveness at roughly the same time as the Package. Meanwhile the media was carrying tales of unannounced dawn inspections at pharmaceutical manufacturers' offices.

This was not really what industry had expected. The Pharmaceutical Package was supposed to stand on its own and address many of the issues industry felt were really important: simplifying pharmacovigilance, facing up to the threat of counterfeit medicines in the supply chain, and improving the supply of information on diseases and medicines to patients. So the delays were frustrating, and launching so close to other, less positive news was not what had been hoped for.

In the end, the animal legislation and sector inquiry were less eventful than feared and when the Package finally did emerge the relief was tangible. The details were interesting. However useful it had been for the media to use the shorthand 'Pharmaceutical Package', the title seemed rather misleading. Although it bundled together much that was relevant to the sector, the separate legislative elements were diverse, not only in content but also in the reactions they provoked and stakeholders they affected.

Streamlining safety
The review of existing pharmacovigilance legislation was probably the least contentious proposal. Its aim – to improve the reporting of drugs safety monitoring – is  a desirable objective on all levels, with  positive implications for patient safety. The Commission's proposal aims to streamline the methods of tracking and reporting adverse reactions. It seeks to clarify where responsibility lies for safety reporting, and to use IT to better coordinate data collection – logical and timely moves. In truth, most of the Commission pharmacovigilance proposal seems broadly in line with expectations and should, in theory, face a relatively untroubled – though not necessarily swift – journey through the EU institutions.

However measures to deal with counterfeit medicines have been less clear cut. Counterfeiting medicines, like counterfeiting iconic clothing brands, is potentially highly lucrative. However, when the fake item is a medicine rather than a handbag, the possible consequences are much more serious – even fatal.  No one wants to see counterfeit medicines enter the supply chain.

The industry had argued that the easiest and most effective way to secure the supply chain was by inserting overt, covert and forensic security features into product packs with a ban on repackaging to ensure that these features are preserved. Manufacturers view repackaging as the weak link in the supply chain. They argue that only securing the supply chain for medicines, from point of manufacture to point of dispensing will maintain security.

Parallel trade off
It was disappointing that the Commission's initial proposal did not include a ban on repackaging. Pharma's logic was challenged by those who benefit from the repackaging – parallel traders. "Not so fast", they said, "There is no evidence of counterfeit medicines entering the supply chain via repackaging: the real issue with counterfeits is with prescription medicines sold over the internet."

Despite the Commission's own evidence to the contrary, parallel traders claim they act as a bulwark against fake products, and that a ban on repackaging would harm business interests and restrict their trade. Traders claim that parallel trade in pharmaceuticals saves national healthcare systems money and provides jobs, and their supporters within the European Parliament are prepared to fight a ban on repackaging 'tooth and nail'.

Cue predictable arguments between the relative merits of the safety of Europe's citizens and the founding principles of European Free Trade enshrined in 1957 in the Treaty of Rome. In their proposal, the Commission stated that a total ban on repackaging was not required, suggesting that as long as 'equivalent' safety features were used by the repackagers, there would be sufficient protection. At the same time, the Commission has recognised the need for increased traceability, putting some of the responsibility back onto repackagers to ensure this is technically possible. EFPIA, the voice of the pharmaceutical industry in Europe, still believes that these measures are insufficient, and has identified this as a priority issue. EFPIA believes a total ban of repackaging is the best solution. The debate has now moved to the European Parliament Committee system, where details will be thrashed out.

Informing patients
If counterfeiting sounds a challenge, the other main proposal – on information to patients – presents yet higher hurdles and inspires even shriller arguments. This is probably the most contentious and controversial section of the Package. Many of the delays were reported to be the result of internal arguments on this topic between different Directorates.

This particular discussion might sound familiar. Those of us who have been around the industry for a few years will be experiencing déjà vu. Just a few years ago we had a similar debate. The European Parliament decided that a proposal to provide information to patients for a set of clearly defined therapy areas was a Trojan horse that would bring US-style DTC (direct-to-consumer) advertising in Europe. Following the exhortations of consumer groups, sick funds and the ever-excitable HAI, the proposal was unceremoniously dumped by parliament.

What has changed to provoke revisiting the topic? Well quite a lot, actually. Most notably, the internet has become the world's number one source of health information. A recent study by Manhattan Research showed that in 2008 the internet replaced GPs as the primary source of health information for Europeans. Much of the traffic was directed at the US sites of major pharmaceutical companies, where access to product information is much more liberal. The information is already out there – in spades.

There are other sources of information, many of them with no approval or quality control standards at all. It is not without irony that pharmaceutical manufacturers, who know more about their products than anyone else, are the ones facing the toughest restrictions on the communication of information on diseases and their treatments. As a result, the question is not whether patients should receive information, but what form this information should take and whom we allow to provide it.

The Commission's motives are admirable. They recognise that, despite the pervasive nature of the internet, access is not yet universal: putting those who cannot take broadband connections for granted at a disadvantage. Equally, the internet is a predominantly Anglophone medium, and is not so open to those whose mother tongue is not English. The challenge is to provide information that is relevant to all Europe's citizens, in their own language, via the most appropriate communications channels.

These circumstances seem to have been enough to soften the position of those, such as patient associations and pharmacists, who had been implacably opposed to any increase of information from pharma to patients. Recognising that the challenge in future will not be supplying information but guaranteeing the quality of information, seems to have stimulated pragmatism. Among those once rigidly opposed to allowing any role for industry in providing information, there seems to be recognition that it may be better to have them – in the words of Lyndon B Johnson – 'inside the tent'.

The industry stance seems to be aligned with this. There is no desire to take a lead in the process, but to be seen as one of a group of trusted bodies who can deliver quality information, and to see information judged solely on its quality, not its provenance. Given the sheer volume of product and disease information that will be required, some kind of public/private partnership seems a likely solution. The industry can also point to the benefits of existing initiatives of information to patients pursued in Sweden and the UK where interpretation of what is permitted has been relatively liberal.

Hopefully this means that the debate (now in the European Parliament) will focus on the details of which channels and outlets can be used and what can be said that is acceptable. It is a complex debate; it will take time and will certainly create controversy – but  it is early days and the battle lines are yet to be drawn.

Only the start
Publication of the Package was only the end of the beginning. Delays to the initial proposal mean that the debates will be interrupted by the election of new MEPs and almost certainly a new Commission. Nobody knows what the European and global financial outlook will be by the end of 2009. One thing is sure: although the pharmaceutical industry has for now stepped out of the light, it will once again face the glare of attention when the legislative heavy lifting starts.

The Author
Colin Mackay is director, communication and partnerships at EFPIA
To comment on this article, email pme@pmlive.com

7th April 2009

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