The Jair Bolsonaro government (PL) is considering allowing drug prices to be raised or lowered at any time, in an exceptional way, instead of just applying annual readjustments.
The team of Minister Paulo Guedes (Economy), however, resists the idea, which is discussed on at least two fronts: MP proposals (provisional measure) and a resolution by Cmed (Drug Market Regulation Chamber).
Behind the resistance of the economic team is the fear that future governments will decide to cut drug prices for political purposes, in an attempt to benefit consumers.
The assessment is that the proposal is very open, leaving in the hands of the Executive a great power of intervention in the market.
On the other hand, government members in favor of the change say that the new rule can help to put some medicines back on the market that would have maximum values ​​below those practiced in the international market – which would make it difficult to offer these drugs in Brazil.
The measure would also make it possible to avoid the shortage of products that suffer high variation in the manufacturing price during a health or political crisis. Prices could still fall in cases such as drugs that lost their patent or gained competitors in the market, say the same sources.
Entities such as Idec (Brazilian Institute for Consumer Protection) are concerned about the possibility of increasing prices at intervals shorter than one year.
In general, drug prices in Brazil have maximum sales values ​​set by the government, which are adjusted annually based on a calculation that takes into account inflation for the period, industry productivity and other factors.
In 2020, the government decided to postpone the adjustment in the price ceiling of medicines because of the coronavirus pandemic in the country. The Ministry of Health now suggests an MP to allow these out-of-hours price revisions.
The government is also discussing a broader change in the way of pricing medicines, through a resolution by Cmed, in which it could also provide for this type of exceptional review of the maximum values ​​of products.
Guedes’ team strongly criticized the MP’s proposal. At a meeting of Cmed’s council of ministers at the end of January, representatives of the Economy said that the measure would leave room for revisions “in an ideological and arbitrary way”.
They also stated that they were against the proposal “because they understand that, by introducing a high degree of subjectivity in the price adjustment, the new rule would generate legal uncertainty in the sector”.
The representative of the Civil House at the meeting said that the proposal was still under analysis in the legal area of ​​the Presidency. The manifestations of the Economy were recorded in the minutes of the meeting, obtained by the sheet.
The assessment in the economic area is that it is not known how future administrations will face questions about drug prices. A source warns of the risk of abuse of power for political ends.
In the view of Guedes’ portfolio, there is no reason to allow the reduction of drug prices at any time because the current pricing has left a margin capable of stimulating competition between pharmaceutical companies. Regarding the increases, team members recognize that the current model can inhibit the agile incorporation of innovations.
The idea of ​​allowing Cmed to move drug prices outside the period of annual adjustments, which usually occur in March, is not new. In 2016 the government of Michel Temer (MDB) presented an MP along this line, but the text expired.
At the time, government officials used the example of the antibiotic penicillin to defend the measure. Manufactured by a few companies, the drug has gone through periods of shortages in the market in recent years.
Even today, Ministry of Health officials try to circumvent price limits for the purchase of some drugs, such as immunoglobulin, made from blood. With no offer in the Brazilian market, the government has exceptionally purchased bottles from the SUS not registered in Brazil.
In addition to the change in the way drugs are readjusted, the government has disputes about strengthening the sector’s regulation or loosening the rules and letting the market dictate prices.
One of the ideas is to transfer from Anvisa (National Health Surveillance Agency) to the Economy the executive secretary of Cmed.
The most solid debate to change the pricing rules for medicines deals with the proposal for a resolution by Cmed that was taken to public consultation in 2021 by SEAE (Secretariat of Advocacy for Competition and Competitiveness).
This discussion involves members of the Health, Justice, Economy and Civil House. A new draft resolution must still undergo regulatory impact analysis. According to government officials who follow the discussion, the trend is for the process to last until the end of the year.
In a note, Guedes’s portfolio said that the proposed resolution “does not have the full agreement of the Ministry of Economy”. “The draft presented there was not prepared exclusively by this ministry and contains proposals from all the members that make up Cmed”, said Economy.
When questioned, Health said only “that the proposal is under analysis”.
In the debate on Cmed’s new resolution, Sindusfarma pointed out that pricing rules in the pharmaceutical sector are delayed. “The biggest example of this is the absurdity of not recognizing an advanced or gene therapy as innovative”, said the entity in the process, in May 2021.
Lawyer and coordinator of the Idec Health program, Ana Carolina Navarrete says that the possibility of reducing drug prices outside the annual review window is positive, but that the idea of ​​an exceptional increase is worrying.
“The bitter memory of hyperinflation lights up the consumer,” said Navarrete.
For the coordinator of Idec, just changing the maximum price of the drug does not solve a problem of shortage of a certain product. The lawyer defends that policies of the national health complex, which involves the production of essential drugs in public laboratories, be reinforced.
The debate on drug pricing has gained greater urgency in the government with the entry of more high-cost products, such as gene therapy.
In one of the cases dealing with these drugs, the CMED council of ministers agreed to raise the ceiling price of zolgensma, a single-dose treatment considered to be the most expensive in the world, from R$2.9 million to R$6.5 million, as revealed to sheet.
Even with the change, there is no guarantee that the Ministry of Health will be able to buy the drug at this price.
As the drug was not launched in Brazil and is outside the SUS, the Union ends up funding the treatment used against SMA (spinal muscular atrophy) at the international price, around R$ 10 million, after court decisions.
GOVERNMENT EVALUATES REVIEW MEDICATION PRICES AT ANY TIME
Proposal, which suffers internal resistance in the government, could become MP or resolution of an agency that defines product values
how is it today
Maximum prices are set by the government and adjusted annually to take account of inflation, industry productivity and other factors.
how can it stay
In addition to the annual readjustment, the government could review amounts at any time, in exceptional cases, such as product shortages or patent fall.
What does the government think?
Economics is against the proposal and says that it leaves room for revisions “in an ideological and arbitrary way”. Another wing of the government, like some members of Saúde, consider that the measure is beneficial to avoid shortages and bring some new products to the market.
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