The Brazilian Government issues the 2017 list of products eligible for PDP proposals

After a long waiting, the Ministry of Health published the List of Strategic Products for the National Healthcare System (SUS), indicating the products eligible to receive proposals for PDPs in the 2017’ roundThe Ministry of Health’s Office published on January 27, 2017, a new list of strategic products for the SUS, Ordinance #252/2017, amended on January 30, 2017. The new list showcases the products that will be part of the 2017’ round of Partnerships for Productive Development (PDP) Program; the first to be issued since the 2015’ round.The issuance of the list is required by the rulemaking of the PDP Program: Ordinance #2,531 of 2014 (section 5). Only the products indicated in the list are eligible to receive PDP proposals by the Government-owned pharmaceutical industries (GOPI) and private companies (alone or as a consortium) interested in signing PDP agreements.Ordinance #252`s annex I indicates the eligible products for proposals, which must be filed by the GOPI with the Ministry of Health`s Department of Science, Technology and Strategic Ingredients (SCTIE/MS) until April 30, 2017. For an overview of the entire process, from the submission of the PDP proposal until its approval, please refer to the enclosed flowchart.Ordinance #252 also mentions the products currently under existing PDP projects or other technology transfer products, in its annex II. These products are not eligible for new proposals.A complete translation of the Ordinance #252/2017 can be downloaded here.In the past, Licks Attorneys has successfully challenged PDP agreements before the Brazilian authorities, having cancelled agreements related to 18 different products that didn’t comply with PDP regulation and Federal Procurement Law. Our team also has in depth experience with the regulation on PDP proposals, having assisted clients in negotiating and submitting the joint proposals before the MoH.For more information, please send an e-mail to info@lickslegal.com .ANNEX I OF ORDINANCE #252 – ELIGIBLE PRODUCTS FOR NEW PDP PROPOSALS1. Abatacept2. Agalsidase alfa3. Amphotericin B4. Amphotericin B Liposomal5. Meglumine antimonate6. Capecitabine7. Certolizumab8. Human prothrombin complex9. Coagulation Factor Concentrates (Factors I, IX, VII recombinant, Factor VIII/von Willebrand, plasma-derived Factor VIII, XIII)10. Daclatasvir11. Dactinomycin12. Darunavir + Ritonavir13. Darunavir14. Dasatinib15. Dolutegravir + Emtricitabine + Tenofovir16. Dolutegravir + Lamivudine17. Dolutegravir + Lamivudine + Tenofovir18. Dolutegravir19. Doxycycline (injectable)20. Eculizumab21. Emtricitabine + Tenofovir22. Erlotinib23. Everolimus24. Fingolimod25. Galsulfase26. Golimumab27. Hydroxyurea28. Imiglucerase29. Glargine (long-acting insulin)30. Aspart (fast-acting insulin)31. L – Asparaginase32. Lenalidomide33. Lopinavir34. Miglustat35. Natalizumab36. Nicotine37. Nilotinib38. Ombitasvir + Veruprevir + Ritonavir + Dasabuvir39. Oseltamivir40. Palivizumab41. Pegaspargase42. Pembrolizumab43. Procarbazine44. Raltegravir45. Simeprevir46. Sofosbuvir47. Vitamins and Minerals Supplement (powder)48. Teriflunomide49. Tocilizumab50. Tofacitinib51. Botulinum toxinANNEX II OF ORDINANCE #252 – NON-ELIGIBLE PRODUCTSFOR NEW PDP PROPOSALS1. Adalimumab2. Epoetin Alfa3. Atazanavir4. Interferon Beta-1a5. Bevacizumab6. Biotin7. Cabergoline8. Sildenafil9. Clozapine10. Entacopone11. Entecavir12. Etanercept13. Allergenic extract14. Recombinant15. factor VII16. Recombinant17. factor VIII18. Filgrastim19. Budesonide – Formoterol20. Galantamine21. Glatiramer22. Gosserrelin23. Infliximab24. Human insulin25. recombinant26. Leflunomide27. Leuprorrelin28. Lopinavir + ritonavir29. Imatinib mesylate30. Mycophenolate (Sodium)31. Octreotide32. Olanzapine33. Pramipexole34. Quetiapine35. Raloxifene36. Ethambutol + Isoniazid + Pyrazinamide + Rifampicin37. Riluzol38. Ritonavir39. Rituximab40. Rivastigmine41. Selegiline42. Sevelamer43. Sirolimus44. Somatropin45. Tacrolimus46. Taliglucerase Alfa47. Tenofovir48. Tenofovir + Lamivudine49. Tenofovir + Lamivudine + Efavirenz50. Tolcapone51. Trastuzumab52. Vaccine Adsorbed Diphtheria, Tetanus and Acellular Pertussis53. Hepatitis A Vaccine54. HPV Vaccine55. Meningococcal C conjugate (MCC) vaccine56. Pneumococcal Vaccine57. Tetraviral vaccine58. Ziprasidone