Medicines Availability and Pricing - part 1 - 5/5/2006

List of recent positions as stated in the media

April 06
Medicines drop from 9,000 to 1,700
The number of medicines on the market could go down to just 1,200 as from next year, Reginald Fava, an official of the Chamber of Commerce and Enterprise, has warned.

As from next year, medicines registered in Malta must be assigned a specific number on the package by the Medicines Authority.

During a meeting with Labour leader Alfred Sant, Mr Fava explained that several drug companies did not want to implement the system because of the small size of the island.

The registration process had led to a dramatic drop in the number of medicines available on the market. Mr Fava pointed out that 9,000 medicines were available in 2000. That has now slipped to just 1,700.

The chairman of the chamber's health care trade section, Joanna Cremona, said the fact that the registration process here was the same as that for the UK, despite the difference in the market size, did not make sense. This was making it difficult to persuade the suppliers to import medicines because of the expenses involved in preparing the necessary paperwork.

The fees that have to be paid whenever there is a small variation in the medicinal content ranges between Lm50 and Lm500.

According to Dr Sant, patients and pharmacy owners had complained about the lack of medicines on the market and about the price hikes.

He agreed it did not make sense to apply the same regulations of much bigger countries to Malta.

Medicines registered in other EU countries should be accepted here, the Labour leader said.


April 25th
Government warns of possible price orders
Ivan Camilleri in Brussels

The government is seriously considering measures aimed at curbing inflation on items such as imported foodstuffs and medicines as preliminary studies show that their prices do not reflect market conditions but may be the effect of price fixing and cartels.

The Times last week reported that new figures out from Europe show that Malta's plans to introduce the euro may be at risk due to the country's high inflation rate.

Contacted for his reaction, Parliamentary Secretary Tonio Fenech yesterday expressed concern and said the government had been monitoring the situation for the past months. He warned that if certain prices, particularly those of imported foodstuffs and medicine, keep failing to reflect market trends, the government would have no option but to intervene, possibly even by re-introducing price orders.

"We have already discussed the issue with the Chamber of Commerce because according to our analysis certain prices of imported products are being fixed by various cartels operating in the local market.

"We don't want to intervene as we believe that competition should be the main driver in the market. However, if things don't change we will have no other option but to intervene."

Although there is still a year to go before the final recommendation on euro adoption by Malta is given by the European Commission and the European Central Bank, Malta's planned entry to the single currency by the start of 2008 is under serious threat.

Data released last week by Eurostat, the EU's statistical arm, show that Malta is on the brink of breaching the inflation criterion, which is considered to be one of the key benchmarks when the Commission forms its opinion on the preparedness of a member state to join the eurozone.

According to the figures, Malta's 12-month inflation average last March reached 2.6 per cent. Under EU rules the inflation rate in eurozone entrants must be within 1.5 percentage points of the average of the three EU countries with the lowest rates.

Currently the ceiling stands at 2.65 per cent although it changes every month depending on the eurozone inflation.

Malta's inflation will have to be in line with the eurozone rules by May of next year, when the EU decision is taken.

Mr Fenech explained that one of the main causes of Malta's high inflation is an international problem in the shape of the high cost of oil.

"We have no control over this. The high price of oil is adversely affecting our inflation as the surcharge has to go up and that will obviously have an impact.

At the same time, this is affecting everyone, even those countries in the eurozone that we have to compare ourselves with at the end of the day and thus we think that this effect will be neutralised. "What we are most concerned about is our internal inflation. From the government's side we are doing everything possible in order not to induce any extra costs in the measures we introduce.

The other aspect is the price of our imported goods. As I said, we are also tackling this directly with the importers."

Medicine importers warn of possible serious crisis
Malta will be facing a serious medical crisis by the end of the year if nothing is done to curb regulation expenses, the healthcare trade section of the Malta Chamber of Commerce and Enterprise has warned.

Due to high costs arising from the European Union directives on drug registration, medicine suppliers overseas have withdrawn products from the Maltese market to the extent that medicines available here have been reduced by about 7,000 items.

The chamber warned that the country might end up with far fewer than 2,000 medicinal items available to the public by January 1, 2007, when new regulations come into force.

The Parliamentary Secretary at the Finance Ministry, Tonio Fenech, said on Monday that cartels and price fixing were pushing up inflation, adding that if certain prices, particularly those of imported foodstuffs and medicine, keep failing to reflect market trends, the government could intervene through price orders.

The healthcare trade section of the Chamber of Commerce and Enterprise said multinational pharmaceutical companies are considering leaving Malta due to the "labour-intensive, disproportionate costs and fees demanded for full product registration and their maintenance on this tiny market". It said it had been excluded from the government's EU negotiating team with the result that recommendations were not lobbied successfully, if at all.

A factor that was increasing costs was the need to get all medicines certified by the Maltese Medicines Authority, which includes allocating staff to go through dossiers with exhaustive technical details of each individual medicinal product. According to the healthcare section, the authority was duplicating the expensive work being done already by similar EU regulatory authorities when it could automatically allow into Malta any product already registered in an EU country so long as a certificate of pharmaceutical product (CCP) existed.

Another expensive task that was contributing to this state of affairs was translating all information leaflets into Maltese. According to the healthcare section, English was sufficient, being one of Malta's official languages, and given that translating all documents was becoming a barrier.

EU rules specify that a product must be allocated a unique Malta market authorisation number which must appear on the outer pack of the product to be sold here. "This simple requirement very often cannot be met because the required production runs are too small, specialised and too costly," the chamber said.

The profits of medicinal importers were dropping when costs were rising, it said.

"This all comes at a time when, on another front, the government is failing in its duty to pay hospital suppliers within a commercially reasonable time, by-passing its own late payment legislation and bringing increased bank interest costs and severe cash flow problems into the equation. This situation significantly reduces the goodwill that overseas suppliers show towards their Malta agents," the chamber's section said.


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