Concorrência não funciona
A Comissão Europeia publicou (28.11.08) um relatório preliminar sobre o inquérito à concorrência no sector farmacêutico: “Pharmaceutical Sector Inquiry, Preliminary Report (DG Competition Staff Working Paper)” link onde se conclui que a concorrência neste sector não funciona de forma satisfatória.
Isto por as empresas de medicamentos de marca recorrerem a diversas práticas com o objectivo de atrasar ou entravar a entrada no mercado dos medicamentos concorrentes.
Isto por as empresas de medicamentos de marca recorrerem a diversas práticas com o objectivo de atrasar ou entravar a entrada no mercado dos medicamentos concorrentes.
Em relação às empresas de genéricos estas práticas «incluem o pedido de múltiplas patentes para o mesmo medicamento (designadas aglomerados de patentes), litígios e processos judiciais, conclusão de acordos sobre patentes que limitam a entrada no mercado das empresas de genéricos, e intervenções junto das autoridades nacionais quando as empresas de produtos genéricos solicitam autorizações regulamentares.»
Com base numa amostra de medicamentos que perderam a exclusividade (patente) no período 2000-2007 nos 17 Estados-Membros o grupo responsável pelo estudo estima que teriam sido possíveis economias adicionais de cerca de 3 mil milhões de euros caso os medicamentos genéricos tivessem entrado imediatamente no mercado.»
pedro moreira, bruxelas
Etiquetas: PM
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Sobre esta matéria gostava de lançar uma pequena provocação ao é-pá tendo em atenção o seu comentário ao post “incidências de mercado” link
Pela primeira vez, está preto no branco. A Comissão Europeia (CE) acusou ontem as empresas farmacêuticas europeias que produzem medicamentos originais de atrasar ou entravar a entrada de genéricos de mercado. No relatório preliminar de centenas de páginas em que o sector é analisado, Portugal surge com destaque pelos piores motivos. Tudo porque o país é recordista no número de acções judiciais que impedem a chegada dos genéricos às farmácias. No total, denuncia a CE, há mais de 70 processos pendentes nos tribunais portugueses e alguns arrastam-se há mais de um ano.
Dos 75 casos pendentes na Europa que contestam as Autorizações de Introdução no Mercado (AIM) dos genéricos, 58 estão a decorrer na justiça portuguesa. Somando todas as acções judiciais que, de alguma forma, fazem com que os genéricos tenham de esperar para entrar no mercado, Portugal terá mais de 70 casos pendentes. Os dados surgem com destaque no relatório divulgado ontem pela CE, que concluiu que a chegada dos medicamentos mais baratos tem sido bloqueada pelas empresas farmacêuticas produtoras de fármacos originais através de inúmeras estratégias que vão desde o pedido de múltiplas patentes para o mesmo medicamento até litígios e processos judiciais. Este bloqueio, dizem, resulta em custos adicionais para os Estados-membros e para os contribuintes. Analisando uma amostra de medicamentos que perderam a exclusividade entre 2000 e 2007 (as patentes protegem os fármacos durante dez anos), a CE estima que teria sido possível poupar cerca de três mil milhões de euros se os genéricos tivessem entrado mais cedo no mercado. O relatório nota ainda que as farmacêuticas aplicaram estratégias defensivas em matéria de patentes para dificultar o desenvolvimento de novos fármacos por parte dos concorrentes.
"Estamos muito satisfeitos, mas só ficaremos totalmente satisfeitos quando esta situação for totalmente desbloqueada", comenta Paulo Lilaia, presidente da Associação Portuguesa de Medicamentos Genéricos (APOGEN), que defende a criação de uma entidade reguladora europeia para tratar das complexas questões de registo de patentes.
Fixação de preços
Sobre Portugal, o responsável nota que o elevado número de casos deve-se ao facto de, ao contrário de outros países na Europa, o processo ficar suspenso enquanto decorre a acção judicial. É que, contestando as AIM emitidas pelo Infarmed, fica suspenso o processo de fixação de preços dos genéricos (da competência da Direcção-Geral das Actividades Económicas, na dependência do Ministério da Economia e Inovação). E sem preço os genéricos não chegam às farmácias. Paulo Lilaia faz questão de frisar que a CE revela que as empresas de medicamentos originais perderam nos tribunais em 95 por cento do casos. "É só uma forma de ganhar tempo e lucrar mais uns meses com a exclusividade", diz o presidente da Apogen, concluindo que "o que o Estado e os utentes perdem, estas empresas ganham".
Em reacção ao relatório da CE, Carlos Pires, porta-voz do Infarmed sublinha que a autoridade apenas tem competência para se pronunciar sobre a "eficácia, segurança e qualidade" do genérico que pediu a AIM e, por isso, sem qualquer relação com o registo ou validade da patente.
Já a Apifarma se limita a referir, em comunicado, que não foi solicitada a sua participação na elaboração do relatório preliminar da CE e remete mais esclarecimentos para a sua congénere europeia. Fonte da Apifarma adiantou apenas que o documento está a ser analisado e que, por isso, prefere não fazer mais comentários.
A Federação Europeia da Indústria Farmacêutica (EFPIA) afirma estar "desapontada" e considera que este inquérito ao sector foi uma "oportunidade perdida", não tendo conseguido "responder aos reais problemas que impedem o acesso a medicamentos inovadores e a necessidade urgente de criar um mercado de genéricos mais eficiente na Europa".
Caro Xavier:
O meu comentário ao post "incidências de mercado" é fácil de entender e não alimenta qualquer atitude ou posição dúbia.
O contexto está subentendido - diria mesmo explícito - nas primeiras linhas em que faço uma espécie de "declaração de interesses":
"Não me compete, nem tenho qualquer tipo de motivação, para defender a inocência, a candura, ou eventuais filantropias da indústria farmacêutica."
Não possuindo na altura, quaisquer informações sobre os mecanismos de concorrência no mercado europeu, não tenho qualquer prurido em associar (a dita concorrência) às minhas naturais reservas sobre o comportamento das multinacionais farmacêuticas.
O meu comentário pretendeu distinguir podutos similares/cópias (para iludir o mercado e prolongar o periodo de protecção das moléculas originais atrasando o aparecimento de genéricos) de produtos isómeros (que são "avanços" do ponto de vista de investigação molecular e com aplicações terapêuticas práticas válidas e promissoras).
Como é facilmente dedutível passei - virtualmente - ao largo dos enormes interesses económicos (que certamente podem conspurcar todo o processo).
"Individuals and governments want a strong pharmaceuticals sector that delivers better products and value for money. But if innovative products are not being produced, and cheaper generic alternatives to existing products are being delayed, then we need to find out why and, if necessary, take action."
Neelie Kroes, European Commissioner for competition
Próximas etapas
Os resultados preliminares do inquérito ao sector são apresentados às partes interessadas numa audição pública a realizar em Bruxelas em 28 de Novembro de 2008. Antes de alcançar as conclusões finais, a Comissão convida todas as partes interessadas a apresentarem as suas observações sobre as conclusões preliminares. A consulta pública está aberta até 31 de Janeiro de 2009. O relatório final terá em conta os comentários recebidos durante a consulta pública e a sua publicação está prevista para a Primavera de 2009.
Following investigations which started early this year Marketletter January 21), the European Commission has now published its preliminary report on the competition inquiry into the pharmaceutical sector, which finds that in this industry it does not work as well as it should. Although not naming specific companies in its report, it is known that raids by EC officials on drugmakers' premises relating to this project included majors such as Pfizer, GlaxoSmithKline and Sanofi-Aventis, and anti-trust action could be instigated against some.
According to the initial findings, there is evidence that brand-name drugmakers have engaged in practices with the objective of delaying or blocking market entry of competing medicines. Practices vis-a-vis generic companies include multiple patent applications for the same medicine (so-called patent clusters), initiation of disputes and litigation, conclusion of patent settlements which constrain market entry of generic companies and interventions before national authorities when copy firms ask for regulatory approvals. Where successful, these practices result in significant additional costs for public health budgets - and ultimately taxpayers and patients - and reduce incentives to innovate, the EC states.
3-billion euros could have been saved
The report takes a sample of medicines that faced loss of exclusivity in the period 2000 to 2007 in 17 member states and estimates that additional savings of around 3.0 billion euros ($3.85 billion) would have been possible on that sample over this period if generic medicines had entered the market without delay. The EC's findings also claim that drugmakers applied defensive patenting strategies, primarily aimed at blocking competitors in the development of new medicines.
Industry body EFPIA takes issue
Noting that the EC's enquiry had missed an opportunity - and fails to address the real issues impeding patient access to innovative medicines, the European Federation of Pharmaceutical Industries and Associations' president, Arthur Higgins, said: "the preliminary report does not adequately recognize the complex and highly-regulated nature of the pharmaceutical market in Europe."
Mr Higgins, also president of Bayer Healthcare, added: that "the report also overstates the level as well as the reasons for delays in generic market access. In line with EFPIA's own findings, DG Competition's analysis has confirmed that where there is a strong commercial incentive, generics enter the market rapidly within four months or less. This compares very favourably with the delay in access by patients to innovative products which can be up to 14 months in some EU markets."
The director general of the EFPIA, Brian Ager, commented, noting that "the Commission's report does not substantiate in any respect their statement made at the opening of the inquiry that the industry is impeding innovation. Over the last few years pharmaceutical research companies have continued to make breakthrough advances in complex therapeutic areas such as cancer, rheumatoid arthritis and HIV/AIDS for the benefit of patients."
Competition Commissioner Neelie Kroes said that these preliminary results show that market entry of generic companies and the development of new and more affordable medicines is sometimes blocked or delayed, at significant cost to health care systems, consumers and taxpayers. "We now have a solid view of what is happening and why: the next step is to discuss our findings with the stakeholders and to draw the necessary conclusions. It is still early days, but the Commission will not hesitate to open anti-trust cases against companies where there are indications that the antitrust rules may have been breached," she warned
Delays or blocks to market entry
The preliminary report shows that originator companies used a variety of methods with the objective of delaying or blocking market entry of generic companies (that sell medicines equivalent to original medicines once patents have expired) and other originators, and therefore maintain high income streams for themselves. The Commission claims that documents found during the sector inquiry included such declarations as:
- "we identify options to obtain or acquire patents for the sole purpose of limiting the freedom of operation of our competitors...Rights covering competitive alternatives are maintained in major markets until risk of competing products appearing is minimal;"
- "I suppose we have all had conversations around 'how can we block generic manufacturers.' (...) Don't play games in patenting new salt forms too late, the generics are starting earlier and earlier. Get (...) claims on key intermediates that cover a number of routes. Process patents are not the biggest block but can put generics off if a superior chemistry job is done;" and
- "interchangeability issues were used in (several countries) to limit generic erosion. (...) Outcome: extra (...) sales of $61.0 million compared to expected generic."
The preliminary report highlights several different specific delaying strategies, including the following aimed at generic companies: Continued on page 12
Continued from page 11 - originator companies filed so-called "patent clusters" - a large number of European Union-wide patents (in one case 1,300) for a single medicine;
- there were also nearly 700 cases of reported patent litigation with generic companies, which on average lasted nearly three years. The copy firms ultimately won more than 60% of these cases;
- originators also concluded more than 200 settlement agreements with generic companies in the EU, in which they agreed on the terms for ending an ongoing litigation or dispute. More than 10% of the settlements were so-called "reverse payment settlements," which limited the entry to the market of the generic medicines and provided for payments from the originator to the copy firm. These payments amounted in total to more than 200.0 million euros; and
- originator companies intervened in national procedures for the approval of generic medicines in a significant number of cases, which on average led to four months of delay for the generic medicine.
The consequences of these practices are important for patients and taxpayers because generic entry on to the market leads to significant decreases in the prices for medicines, says the Commission. Based on a sample of medicines that faced generic entry in the period from 2000 to 2007, average price levels for medicines fall by almost 20% after the first year following a copy's entry. In rare cases, the decline in price levels can be as high as 90%. For the sample under analysis, total savings gained by generic entry amounted to at least 14.0 billion euros over the period. Without these savings, total expenditure for the medicines analyzed would have been over 25% higher, it notes.
"Seven months for generics to enter market"
Moreover, the Commission says, the sector inquiry confirms that generic entry often occurs later than expected. On average it took about seven months for generic products to enter the market on a weighted average basis and even the top-selling medicines faced an average delay of four months.
The preliminary report also found evidence that originator companies practice defensive patenting strategies to fence off competition from other originator companies. This may obstruct innovation, lead to higher costs for competing pharmaceutical companies and delay consumers' access to innovative medicines, it says.
Stakeholders also made a significant number of comments on the regulatory framework. In particular, both generic and originator companies called for a single Community Patent and the creation of a unified and specialized patent judiciary in Europe. These calls are supported by the preliminary finding, that discovered 11% of contradictory final judgments in litigation cases and total direct costs associated with the patent litigation of 420.0 million euros. Such contradictions and the costs related to the litigation could be avoided, or as a strict minimum reduced, with a Community Patent and an unified specialized patent judiciary.
Need more market-oriented system; EFPIA
Continuing its critique of the Commission's findings the EFPIA said that, in looking at the access delays of generics, the report does not address inefficiencies in the generic market nor why European citizens pay less for innovative pharmaceutical products but more for copy medicines than do citizens in the USA. A more market-oriented mechanism is necessary to ensure an efficient generic market that generates appropriate savings for health care systems, the association argues.
It points to the fact that the Commission's report's headline is that swifter generic entry would have achieved savings of 3.0 billion euros over eight years across 17 countries, which is 375.0 million euros a year. However, says the EFPIA, the same report fails to emphasize that a single member state, the Netherlands, achieved greater savings - up to 400.0 million euros - in one year, on only 33 medicines, simply by promoting active price competition between generics.
The report acknowledges that patents are key to pharmaceutical innovation and should be protected, noted the EFPIA, adding that it then contradicts itself by questioning the right of the industry to use perfectly lawful practices - such as patent portfolios, patent litigation and the release of improved medicines. These are essential for innovators to protect their huge investments in R&D. Indeed, says the association, the interim report accepts that the pharmaceutical sector spends 17% of its turnover on R&D which is more than any other industry sector in Europe. Furthermore, the report does not establish that such activities deter generic entry because the facts on generic entry tell a different story.
"We also acknowledge the conclusion that a Community patent could reduce costs and bring more legal certainty. [The] EFPIA is already actively engaged with the Commission on the development of a cost-effective litigation system that provides legal certainty and above all gives high quality decisions," added Mr Ager.
Next steps
The preliminary findings of the sector inquiry were presented to stakeholders at a public hearing in Brussels on November 28. Before reaching final conclusions, the Commission invites all interested parties to submit their views and observations on the preliminary findings. The public consultation lasts until January 31, 2009. The final report will take into account comments received during the consultation and is expected for spring 2009.
Source & copyright: Pharma Marketletter
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