An uphill struggle for European Pharma
Sometimes you just have to feel sorry for the European pharmaceutical industry. It tries and tries and tries to obtain that long-sought level playing field so that it can up its game and keep scoring in international competition. Because the pitch is often sloped against it, and it often finds itself playing into the wind as well as uphill, each of its occasional successes is a real triumph of heroism over adversity. Sometimes, as it struggles to improve the conditions it has to operate, it just goes wrong.
It has just gone horribly wrong for the industry's long-running battle to combat counterfeit drugs.
The European industry's campaign to beat fraudsters is just reaching its climax. As this column recently remarked, it is one of the current priorities for the industry. Discussions are underway right now in the European Union institutions about how to combat counterfeiters.
The industry was starting to feel that its efforts were at last paying off, with European lawmakers coming round to its point of view, and exploring ways of tightening up the trade rules. Then Dutch customs officers moved in on shipments of medicines in transit in its ports and airports, and held some of them for up to a month while they investigated whether they were counterfeit.
They were not counterfeit, it emerged. On the contrary, the evidence was that they were bona fide medicines. Some were manufactured in India and being shipped to supply urgent needs in Brazil. Others were destined for Colombia and Peru. The seizures also included a shipment bound for Nigeria ordered by UN drug purchasing agency UNITAID, and involving former US President Clinton's foundation. They were generic medicines, but there was no demonstration that they were counterfeit.
All hell broke loose, leaving the European drug industry, and its anti-counterfeiting campaign, looking distinctly unappealing.
How do you push for tighter trade rules when even the boss of the world's key trade body, the World Trade Organisation, says in public he is ready to help out in preventing any further similar misunderstandings? Pascal Lamy, its director general, said on March 4: "The issue at stake is certainly very important and sensitive. As such, it deserves to be adequately addressed so that efforts to enhance access to medicines are supported and the creation of barriers to legitimate trade in generics is avoided." He was replying to a letter from outraged development aid organisations, including Médecins Sans Frontières and Oxfam.
However, Lamy had already received plenty of first-hand information about the seizure. The delegations of Brazil and India had raised the matter at the WTO's General Council meeting in early February and at at a meeting of the WTO's intellectual property Council in early March. On both occasions, the EU delegation had squirmed with embarrassment and tried to recover as much credibility as possible by reiterating its commitment to "the efforts being made to facilitate access to medicines."
As if concerns within WTO were not enough, the World Health Organisation added its condemnation in mid-March: "Recent events related to the handling of medicines in transit and the potential consequences for the supply of medicines in developing countries are of major concern to the organisation."
The EU Council of Ministers is also facing questions from incredulous members of the European Parliament. "What steps will the Council take to ensure that the supply of generic medicines to developing countries is not thwarted by similar seizures in future?" demanded David Martin in March.
Inevitably, concerns were expressed by health activists that authorities are acting on behalf of developed-nation patent holders to interfere with generics trade. Allegations have been made that specific companies, including MSD and Sanofi-Aventis, were instrumental in seeking the seizures. And bodies including WHO and the EU have been accused of showing a lack of leadership and an inability to resist pressure for intrusive action from brand-name producers.
In a timid bid to rescue what dignity it can for its bid to clamp down on counterfeiters, the European Federation of Pharmaceutical Industries (EFPIA) and Associations has now issued a statement urging that the seizures should not be "misconstrued." The trade association insists it is "neither the policy nor practice of our members to encourage member states to use the powers of detention available to them to prevent the flow of legitimate generic products from manufacturer to customer outside the EU." But it maintains that member states must be allowed to stop products that they suspect may be counterfeit from entering the supply chain, and "on occasions this will require the temporary detention of some products for the purposes of verification and testing." EFPIA's only concession to "the concerns of the wider community" is that it has "requested that member companies re-examine their procedures to ensure that any inappropriate interceptions are resolved as a matter of urgency."
In this needle-match between the European pharmaceutical industry and public opinion, the chances of victory have been sharply eroded by what looks like a catastrophic own-goal at a crucial point in the game.
How Digital Medicine Can Pinpoint Dosing Regimens to Optimize Drug Efficacy and Safety