AGERPRES special correspondent Florin Stefan reports: Romania wants to be part of strategic drug production projects that will be facilitated by the adoption of the Critical Medicines Act and would like a fair distribution mechanism in the event of a pharmaceutical crisis, Save Romania Union (USR) MEP Vlad Voiculescu, Renew Group shadow rapporteur for this legislation, declared in Strasbourg.

Voiculescu says that the new legislation, on which the EU legislature is to present its negotiating position on December 2, is based on several realities, including 'the disappearance of certain drugs from the market almost constantly and not only from countries like Romania or Bulgaria or Hungary, but also from countries that can afford a little more'.

In a briefing for Romanian journalists, the MEP explained that these are 'very cheap drugs, which have been on the market for 30, 40, 50 years and which cannot be replaced'.

'The effect is that you can suddenly have hundreds or thousands of children or adults suffering from cancer, from other pathologies, who cannot be treated. The World Health Organization calls these essential drugs. (...) The effects are dramatic,' stated the former Romanian health minister.

Another category of problems is related to the fact that the production of generic drugs, for which the profit margin is generally much lower and which are produced by more companies compared to innovative ones, 'has moved in the last 15 years to a great extent towards China, India'.

In addition, Voiculescu said, 80% of the active ingredients in generic drugs, which represent 80% of the total, 'are again produced in China or India'.

'Basically, if a trade war or any kind of conflict were to erupt between the US and China, and Europe had to choose sides - and we imagine which side it would take - there is a major risk that 80% of the active ingredients for 80% of medicines would suddenly become unavailable. That is another major vulnerability,' Voiculescu warned.

A third type of problem that the law tries to address is the tendency of states to stockpile drugs.

'(...) In recent years, countries such as Germany have imposed strategic supply reserves. More precisely, if a pharmaceutical company wanted to sell in Germany, it had to set aside half of its annual contracted quantity - equivalent to six months' supply - in a warehouse designated for Germany, unavailable for other markets. In this way, Germany guarantees six months of medicine consumption at all times. France, Finland, and other countries have adopted similar measures,' explained the USR MEP.

The answer that the law in question gives to this problem is 'to have a common cabinet to which the Commission must have the key', based on a pre-established mechanism that is fair for everyone. 'So we need 100,000 medicines, (but) we have (only) 60,000, let's divide them fairly according to population, so that every country has access to those medicines.'

On the other hand, Voiculescu noted that legislation on critical medicines offers partial solutions to these vulnerabilities.

'We are talking about European strategic projects that could benefit from EU funding. At the level of the Union, we have already acknowledged the existence of problems and vulnerabilities. Some must therefore be addressed collectively - for example, the fact that most active substances are produced in China and India. Part of that production, or at least the capacity to produce it, should be relocated to Europe. But such production capacities cannot be built without funding and other forms of support,' Voiculescu explained.

The new legislation talks about funds that could go towards strategic projects initiated by several member states and also about various facilities, such as relaxing the rules for state aid or giving priority to energy supply.

Also, the new legislation regulates, in addition to the possible solution of strategic projects, that of centralized procurement.

'The Commission said that if at least nine countries join forces to buy a medicine, they can do so voluntarily, not as a mandate. In that case, the Commission provides the technical secretariat, which is crucial. Negotiating together is always more effective - you can secure a lower price or reach a better deal. Some companies avoid markets like Bulgaria or Romania because our prices must be lower, which undermines pricing in richer countries,' the official explained.

After the Commission initially proposed that nine countries would be required for a joint medicine purchase, Vlad Voiculescu said he suggested lowering the threshold to three.

'It seems we are moving toward a compromise of at least five countries. I also proposed including candidate states, with Moldova in mind, and this was accepted. A bilateral agreement will probably still be needed, but it is merely a formality. In practice, when Romania and four other countries decide to buy a medicine together, Moldova will be able to join the package and benefit from lower prices and better conditions,' the Renew MEP explained.

'It would be great if Romania were part of these strategic projects sooner or later. If we could bring production to Romania. It would be great for Romania to have that mechanism for equitable distribution in case of a crisis of available medicines, that key to the cabinet that I was talking about, and that is a matter for negotiation (...),' said Voiculescu.

Voiculescu added that Romania's potential partners in projects under the new legislation would likely be 'eastern countries and smaller states.'

'Countries like France, Germany or Sweden have very strict regulations and essentially prioritize their own populations, having already taken safety measures. They generally prefer not to have European-level regulation, since they manage their own needs. By contrast, many smaller and poorer countries argue that 'we are a family, we need a common mechanism',' Voiculescu explained. AGERPRES (RO - editing by: Gabriela Ionescu; EN - writing by: Simona Klodnischi)